tag:blogger.com,1999:blog-161312262024-03-13T10:56:20.417+08:00Generic Drug, API & DMFGMP, DMF, active pharmaceutical ingredients (APIs), ドラッグマスターファイル,原薬 原料藥, generic drug, 學名藥, 仿制藥, biogeneric drugAnonymoushttp://www.blogger.com/profile/00641862248583269952noreply@blogger.comBlogger181125tag:blogger.com,1999:blog-16131226.post-64575549390647985402015-03-06T08:30:00.003+08:002015-03-06T08:30:31.014+08:00第17 回医薬品品質フォーラムシンポジウム<center>
<span><b>第17 回医薬品品質フォーラムシンポジウム</b></span><b><br />
<span style="color: olive; font-family: ARIAL;"><i>2015/2/9、東京 </i></span></b><br />
<b>
</b>
<hr size="4" />
<b><br />
講演スライド<br /></b></center>
<b>
<hr size="4" />
<ol>
<li><a href="http://www.nihs.go.jp/drug/PhForum/17thRecord/17Forum01.pdf"> PIC/S加盟後の医薬品規制の変化と課題</a>
<dd>厚生労働省 医薬食品局監視指導麻薬対策課 小池 紘一郎</dd>
<br />
</li>
<li><a href="http://www.nihs.go.jp/drug/PhForum/17thRecord/17Forum02.pdf">PIC/S加盟後のGMP査察と企業への期待</a>
<dd>医薬品医療機器総合機構 品質管理部 森末 政利 </dd>
<br />
</li>
<li><a href="http://www.nihs.go.jp/drug/PhForum/17thRecord/17Forum03.pdf">PIC/S加盟後のGMP査察における留意点-地方省の現場から</a>
<dd> 神奈川県 保健福祉局生活衞生部薬務課 阿武野 晴美</dd>
<br />
</li>
<li><a href="http://www.nihs.go.jp/drug/PhForum/17thRecord/17Forum04.pdf">GMP査察のグローバル化に伴うインパクト-内資新薬メーカーの立場から</a>
<dd>日本製薬工業協会・第一三共株式会社 清水 直樹 </dd>
<br />
</li>
<li><a href="http://www.nihs.go.jp/drug/PhForum/17thRecord/17Forum05.pdf">GMP査察のグローバル化に伴うインパクト-外資新薬メーカーの立場から</a>
<dd> 日本製薬工業協会・ベーリンガーインゲルハイム製薬株式会社 瀬古 則貴</dd>
<br />
</li>
<li><a href="http://www.nihs.go.jp/drug/PhForum/17thRecord/17Forum06.pdf"> GMP査察のグローバル化に伴うインパクト-ジェネリック医薬品メーカーの立場から</a>
<dd> 日本ジェネリック製薬協会・日医工株式会社 中川 涼</dd>
<br />
</li>
<li><a href="http://www.nihs.go.jp/drug/PhForum/17thRecord/17Forum07.pdf">GMP査察のグローバル化に伴うインパクト- 製造受託メーカーの立場から- KFDA&BPOMの査察を受けて</a>
<dd> 医薬品製剤協議会・生晃栄養薬品株式会社 山口 隆弘</dd>
<br />
</li>
<li><a href="http://www.nihs.go.jp/drug/PhForum/17thRecord/17Forum08.pdf">GMP査察のグローバル化に伴うインパクト-製造受託メーカーの立場から</a>
<dd>日本CMO協会・武州製薬 笠井 隆行 </dd>
<br />
</li>
<li><a href="http://www.nihs.go.jp/drug/PhForum/17thRecord/17Forum09.pdf">GMP査察のグローバル化に伴うインパクト-原薬製造業者の立場から</a>
<dd> 日本医薬品原薬工業会・白鳥製薬株式会社 田澤 信之介</dd>
<br />
</li>
</ol>
(敬称略)<br />
<hr size="4" width="50%" />
<span style="font-size: x-small;">更新日: 2015年 3月 5日</span></b>Anonymoushttp://www.blogger.com/profile/00641862248583269952noreply@blogger.com0tag:blogger.com,1999:blog-16131226.post-12205944145734245042013-08-26T08:37:00.000+08:002013-08-26T08:37:40.163+08:00「生物学的同等性に関する最近の議論 -BE試験ガイドラインの改訂 及び 開発段階におけるBA/BEの評価- 」2013.1.15<br />
<br />
<span lang="EN-US" style="mso-bidi-font-family: "MS 明朝";"><span style="mso-list: Ignore;">1)</span></span>フォーラム開催の経緯と概要 <a href="http://www.nihs.go.jp/drug/PhForum/13thRecord/1yomota.pdf"><span lang="EN-US"><span lang="EN-US"><span lang="EN-US">(PDF)</span></span></span></a>
<br />
<div class="MsoNormal" style="margin-left: 70.0mm; mso-para-margin-left: 18.9gd;">
四方田 千佳子(国立衛研<span lang="EN-US"></span>)</div>
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<span lang="EN-US" style="mso-bidi-font-family: "MS 明朝";"><span style="mso-list: Ignore;"><br />
2)</span></span>後発医薬品の生物学的同等性試験ガイドライン等の改訂内容 <a href="http://www.nihs.go.jp/drug/PhForum/13thRecord/2muranushi.pdf"><span lang="EN-US"><span lang="EN-US"><span lang="EN-US">(PDF)</span></span></span></a> </div>
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村主 教行(塩野義製薬)<span lang="EN-US"></span></div>
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<span lang="EN-US" style="mso-bidi-font-family: "MS 明朝";"><span style="mso-list: Ignore;"><br />
3)</span></span>医療用配合剤の生物学的同等性試験に関する新規追加Q&Aについて <a href="http://www.nihs.go.jp/drug/PhForum/13thRecord/3nagai.pdf"><span lang="EN-US"><span lang="EN-US"><span lang="EN-US">(PDF)</span></span></span></a> </div>
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永井 尚美(PMDA)<span lang="EN-US"></span></div>
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<span lang="EN-US" style="mso-bidi-font-family: "MS 明朝";"><span style="mso-list: Ignore;"><br />
4)</span></span>PPI投与による低胃酸被験者を模した臨床試験条件の構築 <a href="http://www.nihs.go.jp/drug/PhForum/13thRecord/4tachiki.pdf"><span lang="EN-US"><span lang="EN-US"><span lang="EN-US">(PDF)</span></span></span></a> </div>
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立木 秀尚(東和薬品)<span lang="EN-US"></span></div>
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<span lang="EN-US" style="mso-bidi-font-family: "MS 明朝";"><span style="mso-list: Ignore;"><br />
5)</span></span>開発段階における生物学的同等性試験の課題① <a href="http://www.nihs.go.jp/drug/PhForum/13thRecord/5hamaura.pdf"><span lang="EN-US"><span lang="EN-US"><span lang="EN-US">(PDF)</span></span></span></a> </div>
<div class="MsoNormal" style="margin-left: 70.0mm; mso-para-margin-left: 18.9gd;">
濱浦 健司(第一三共)<span lang="EN-US"></span></div>
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<span lang="EN-US" style="mso-bidi-font-family: "MS 明朝";"><span style="mso-list: Ignore;"><br />
6)</span></span>開発段階における生物学的同等性試験の課題② <a href="http://www.nihs.go.jp/drug/PhForum/13thRecord/6okazaki.pdf"><span lang="EN-US"><span lang="EN-US"><span lang="EN-US">(PDF)</span></span></span></a> </div>
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岡崎 公哉(製薬協)<span lang="EN-US"></span></div>
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<span lang="EN-US" style="mso-bidi-font-family: "MS 明朝";"><span style="mso-list: Ignore;"><br />
7)</span></span>生物学的同等性試験の今後の流れ <a href="http://www.nihs.go.jp/drug/PhForum/13thRecord/7kaichi.pdf"><span lang="EN-US"><span lang="EN-US"><span lang="EN-US">(PDF)</span></span></span></a> </div>
<div class="MsoNormal" style="margin-left: 70.0mm; mso-para-margin-left: 18.9gd;">
鶏内 雅司(医薬食品局審査管理課)</div>
Anonymoushttp://www.blogger.com/profile/00641862248583269952noreply@blogger.com0tag:blogger.com,1999:blog-16131226.post-29231692403593285222013-08-26T08:14:00.001+08:002013-08-26T08:14:48.516+08:00「ICH Q11:その意義と日本への適用 」 発表スライド 2013.3.5<br />
<span lang="EN-US" style="mso-bidi-font-family: "MS 明朝";"><span style="mso-list: Ignore;">●医薬品品質フォーラム 第14回シンポジウム(2013.3.5、きゅりあん(品川区総合区民会館)大ホール)<br clear="none" />
<span><b>「<span style="font-family: "MS 明朝","serif"; font-size: 12.0pt; mso-ansi-language: EN-US; mso-ascii-font-family: Century; mso-bidi-font-family: "Times New Roman"; mso-bidi-language: AR-SA; mso-fareast-language: JA; mso-font-kerning: 1.0pt;"></span>ICH Q11:その意義と日本への適用
」</b></span></span></span><br />
<span lang="EN-US" style="mso-bidi-font-family: "MS 明朝";"><span style="mso-list: Ignore;"><span><b> </b></span>1)</span></span>01Q11ガイドラインのスコープ <a href="http://www.nihs.go.jp/drug/PhForum/14thRecord/14Forum1.pdf"><span lang="EN-US"><span lang="EN-US"><span lang="EN-US">(PDF)</span></span></span></a>
<br />
<div class="MsoNormal" style="margin-left: 70.0mm; mso-para-margin-left: 18.9gd;">
安藤剛(PMDA<span lang="EN-US"></span>)</div>
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<span lang="EN-US" style="mso-bidi-font-family: "MS 明朝";"><span style="mso-list: Ignore;"><br />
2)</span></span>製造工程開発 <a href="http://www.nihs.go.jp/drug/PhForum/14thRecord/14Forum2.pdf"><span lang="EN-US"><span lang="EN-US"><span lang="EN-US">(PDF)</span></span></span></a> </div>
<div class="MsoNormal" style="margin-left: 70.0mm; mso-para-margin-left: 18.9gd;">
高木公司(Q11 EWG 専門家)<span lang="EN-US"></span></div>
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<span lang="EN-US" style="mso-bidi-font-family: "MS 明朝";"><span style="mso-list: Ignore;"><br />
3)</span></span>出発物質と管理戦略 <a href="http://www.nihs.go.jp/drug/PhForum/14thRecord/14Forum3.pdf"><span lang="EN-US"><span lang="EN-US"><span lang="EN-US">(PDF)</span></span></span></a> </div>
<div class="MsoNormal" style="margin-left: 70.0mm; mso-para-margin-left: 18.9gd;">
奥田晴宏(国立衛研)松村清利(大塚化学)<span lang="EN-US"></span></div>
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<span lang="EN-US" style="mso-bidi-font-family: "MS 明朝";"><span style="mso-list: Ignore;"><br />
4)</span></span>品質リスクマネジメントに基づく承認申請書の記載 <a href="http://www.nihs.go.jp/drug/PhForum/14thRecord/14Forum4.pdf"><span lang="EN-US"><span lang="EN-US"><span lang="EN-US">(PDF)</span></span></span></a> </div>
<div class="MsoNormal" style="margin-left: 70.0mm; mso-para-margin-left: 18.9gd;">
高木和則(PMDA)<span lang="EN-US"></span></div>
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<span lang="EN-US" style="mso-bidi-font-family: "MS 明朝";"><span style="mso-list: Ignore;"><br />
5)</span></span>プロセスバリデーションとライフサイクルマネジメント <a href="http://www.nihs.go.jp/drug/PhForum/14thRecord/14Forum5.pdf"><span lang="EN-US"><span lang="EN-US"><span lang="EN-US">(PDF)</span></span></span></a> </div>
<div class="MsoNormal" style="margin-left: 70.0mm; mso-para-margin-left: 18.9gd;">
仲川知則(大塚製薬)<span lang="EN-US"></span></div>
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<span lang="EN-US" style="mso-bidi-font-family: "MS 明朝";"><span style="mso-list: Ignore;"><br />
6)</span></span>バイオテクノロジー応用医薬品へのQ11の適用と課題1 <a href="http://www.nihs.go.jp/drug/PhForum/14thRecord/14Forum6.pdf"><span lang="EN-US"><span lang="EN-US"><span lang="EN-US">(PDF)</span></span></span></a> </div>
<div class="MsoNormal" style="margin-left: 70.0mm; mso-para-margin-left: 18.9gd;">
安藤剛(PMDA)<span lang="EN-US"></span></div>
<div class="MsoNormal" style="margin-left: 21.0pt; mso-list: l0 level1 lfo2; tab-stops: list 21.0pt; text-indent: -21.0pt;">
<span lang="EN-US" style="mso-bidi-font-family: "MS 明朝";"><span style="mso-list: Ignore;"><br />
7)</span></span>バイオテクノロジー応用医薬品へのQ11の適用と課題2 <a href="http://www.nihs.go.jp/drug/PhForum/14thRecord/14Forum7.pdf"><span lang="EN-US"><span lang="EN-US"><span lang="EN-US">(PDF)</span></span></span></a> </div>
<div class="MsoNormal" style="margin-left: 70.0mm; mso-para-margin-left: 18.9gd;">
古賀淳一(第一三共)<span lang="EN-US"></span></div>
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<span lang="EN-US" style="mso-bidi-font-family: "MS 明朝";"><span style="mso-list: Ignore;"><br />
8)</span></span>08Q-IWGのQ8910の実施に関する指針からみたQ11 <a href="http://www.nihs.go.jp/drug/PhForum/14thRecord/14Forum8.pdf"><span lang="EN-US"><span lang="EN-US"><span lang="EN-US">(PDF)</span></span></span></a> </div>
<div class="MsoNormal" style="margin-left: 70.0mm; mso-para-margin-left: 18.9gd;">
松田嘉弘(PMDA) </div>
Anonymoushttp://www.blogger.com/profile/00641862248583269952noreply@blogger.com0tag:blogger.com,1999:blog-16131226.post-4986216861486885422011-11-22T08:38:00.001+08:002011-11-22T08:46:02.415+08:00美國開發中的生技醫藥Biotech pipeline products in USA<br />
內容請參考這份幾十頁的報告。 <br />
<a href="http://www.phrma.org/sites/default/files/1776/biotech2011.pdf">http://www.phrma.org/sites/default/files/1776/biotech2011.pdf</a><br />
<br />
<table border="0" cellpadding="0" cellspacing="0" style="width: 311px;"><colgroup><col style="mso-width-alt: 4864; mso-width-source: userset; width: 103pt;" width="137"></col>
<col span="2" style="mso-width-alt: 3100; mso-width-source: userset; width: 65pt;" width="87"></col>
</colgroup><tbody>
<tr height="21" style="height: 15.6pt; mso-height-source: userset;">
<td class="xl64" height="21" style="height: 15.6pt; width: 103pt;" width="137">化合物分類</td>
<td class="xl64" style="border-left: none; width: 65pt;" width="87">品項數</td>
<td class="xl64" style="border-left: none; width: 65pt;" width="87">比率(%)</td>
</tr>
<tr height="21" style="height: 15.6pt; mso-height-source: userset;">
<td class="xl65" height="21" style="border-top: none; height: 15.6pt; width: 103pt;" width="137">單株抗體</td>
<td class="xl66" style="border-left: none; border-top: none; width: 65pt;" width="87">300</td>
<td class="xl66" style="border-left: none; border-top: none; width: 65pt;" width="87">33.3</td>
</tr>
<tr height="21" style="height: 15.6pt; mso-height-source: userset;">
<td class="xl65" height="21" style="border-top: none; height: 15.6pt; width: 103pt;" width="137">疫苗</td>
<td class="xl66" style="border-left: none; border-top: none; width: 65pt;" width="87">298</td>
<td class="xl66" style="border-left: none; border-top: none; width: 65pt;" width="87">33.1</td>
</tr>
<tr height="21" style="height: 15.6pt; mso-height-source: userset;">
<td class="xl65" height="21" style="border-top: none; height: 15.6pt; width: 103pt;" width="137">融合蛋白</td>
<td class="xl66" style="border-left: none; border-top: none; width: 65pt;" width="87">78</td>
<td class="xl66" style="border-left: none; border-top: none; width: 65pt;" width="87">8.7</td>
</tr>
<tr height="21" style="height: 15.6pt; mso-height-source: userset;">
<td class="xl65" height="21" style="border-top: none; height: 15.6pt; width: 103pt;" width="137">細胞治療</td>
<td class="xl66" style="border-left: none; border-top: none; width: 65pt;" width="87">64</td>
<td class="xl66" style="border-left: none; border-top: none; width: 65pt;" width="87">7.1</td>
</tr>
<tr height="21" style="height: 15.6pt; mso-height-source: userset;">
<td class="xl65" height="21" style="border-top: none; height: 15.6pt; width: 103pt;" width="137">基因治療</td>
<td class="xl66" style="border-left: none; border-top: none; width: 65pt;" width="87">50</td>
<td class="xl66" style="border-left: none; border-top: none; width: 65pt;" width="87">5.5</td>
</tr>
<tr height="21" style="height: 15.6pt; mso-height-source: userset;">
<td class="xl65" height="21" style="border-top: none; height: 15.6pt; width: 103pt;" width="137">Antisense</td>
<td class="xl66" style="border-left: none; border-top: none; width: 65pt;" width="87">23</td>
<td class="xl66" style="border-left: none; border-top: none; width: 65pt;" width="87">2.6</td>
</tr>
<tr height="21" style="height: 15.6pt; mso-height-source: userset;">
<td class="xl65" height="21" style="border-top: none; height: 15.6pt; width: 103pt;" width="137">Interferon</td>
<td class="xl66" style="border-left: none; border-top: none; width: 65pt;" width="87">20</td>
<td class="xl66" style="border-left: none; border-top: none; width: 65pt;" width="87">2.2</td>
</tr>
<tr height="21" style="height: 15.6pt; mso-height-source: userset;">
<td class="xl65" height="21" style="border-top: none; height: 15.6pt; width: 103pt;" width="137">RNA干擾</td>
<td class="xl66" style="border-left: none; border-top: none; width: 65pt;" width="87">13</td>
<td class="xl66" style="border-left: none; border-top: none; width: 65pt;" width="87">1.4</td>
</tr>
<tr height="21" style="height: 15.6pt; mso-height-source: userset;">
<td class="xl65" height="21" style="border-top: none; height: 15.6pt; width: 103pt;" width="137">成長因子</td>
<td class="xl66" style="border-left: none; border-top: none; width: 65pt;" width="87">10</td>
<td class="xl66" style="border-left: none; border-top: none; width: 65pt;" width="87">1.1</td>
</tr>
<tr height="21" style="height: 15.6pt; mso-height-source: userset;">
<td class="xl65" height="21" style="border-top: none; height: 15.6pt; width: 103pt;" width="137">其他</td>
<td class="xl66" style="border-left: none; border-top: none; width: 65pt;" width="87">45</td>
<td class="xl66" style="border-left: none; border-top: none; width: 65pt;" width="87">5</td>
</tr>
<tr height="21" style="height: 15.6pt; mso-height-source: userset;">
<td class="xl65" height="21" style="border-top: none; height: 15.6pt; width: 103pt;" width="137">合計</td>
<td class="xl66" style="border-left: none; border-top: none; width: 65pt;" width="87">901</td>
<td class="xl66" style="border-left: none; border-top: none; width: 65pt;" width="87">100</td>
</tr>
</tbody></table>
<br />
<br />Anonymoushttp://www.blogger.com/profile/00641862248583269952noreply@blogger.com0tag:blogger.com,1999:blog-16131226.post-91584602648150646562011-10-03T09:42:00.002+08:002011-10-03T09:45:24.442+08:00Wikileaks@Taiwan Pharma: Slower Approvals, Lower PricesA lot of complaints by American pharma subsidiary in Taiwan...<br />
Very true!<br />
<br />
<a href="http://taipeizin.posterous.com/wikileaks-08taipei572">http://taipeizin.posterous.com/wikileaks-08taipei572</a><br />
<br />Anonymoushttp://www.blogger.com/profile/00641862248583269952noreply@blogger.com0tag:blogger.com,1999:blog-16131226.post-65772723355522494662011-08-17T09:48:00.002+08:002011-08-17T12:50:20.293+08:00Taiwan Medtech Fund(TMF)発足<div class="MsoNormal"><span lang="ZH-CN" style="font-family: "新細明體","serif";">「台灣生技醫療產業發展論壇─從生技創投基金之啟航看台灣生技醫療產業發展策略與未來競爭力」</span></div><div class="MsoNormal"><br />
</div><div class="MsoNormal"><span lang="ZH-CN" style="font-family: "新細明體","serif";">•</span><span lang="EN-US"> </span><span lang="ZH-CN" style="font-family: "新細明體","serif";">時間</span><span lang="EN-US"> : </span><span lang="ZH-CN" style="font-family: "新細明體","serif";">民國</span><span lang="EN-US">100</span><span lang="ZH-CN" style="font-family: "新細明體","serif";">年</span><span lang="EN-US">8</span><span lang="ZH-CN" style="font-family: "新細明體","serif";">月</span><span lang="EN-US">16</span><span lang="ZH-CN" style="font-family: "新細明體","serif";">日</span><span lang="EN-US"> (</span><span lang="ZH-CN" style="font-family: "新細明體","serif";">星期二</span><span lang="EN-US">) </span><span lang="ZH-CN" style="font-family: "新細明體","serif";">下午</span><span lang="EN-US">13</span><span lang="ZH-CN" style="font-family: "新細明體","serif";">:</span><span lang="EN-US">00 ~ 17</span><span lang="ZH-CN" style="font-family: "新細明體","serif";">:</span><span lang="EN-US">20 </span></div><div class="MsoNormal"><span lang="ZH-CN" style="font-family: "新細明體","serif";">•</span><span lang="EN-US"> </span><span lang="ZH-CN" style="font-family: "新細明體","serif";">地點</span><span lang="EN-US"> : W Hotel </span><span lang="ZH-CN" style="font-family: "新細明體","serif";">–風尚廳</span><span lang="EN-US"> / </span><span lang="ZH-CN" style="font-family: "新細明體","serif";">台北市信義區忠孝東路</span><span lang="EN-US">5</span><span lang="ZH-CN" style="font-family: "新細明體","serif";">段</span><span lang="EN-US">10</span><span lang="ZH-CN" style="font-family: "新細明體","serif";">號</span><span lang="EN-US">8 F (</span><span lang="ZH-CN" style="font-family: "新細明體","serif";">統一阪急</span><span lang="EN-US">)</span></div><div class="MsoNormal"><span lang="ZH-CN" style="font-family: "新細明體","serif";">•</span><span lang="EN-US"> </span><span lang="ZH-CN" style="font-family: "新細明體","serif";">主辦單位</span><span lang="EN-US">: </span><span lang="ZH-CN" style="font-family: "新細明體","serif";">台灣玉山科技協會、中華民國生物產業發展協會、國家生技醫療產業策進會、資誠聯合會計師事務所</span><span lang="EN-US"> PWC</span></div><div class="MsoNormal"><br />
</div><div class="MsoNormal"><span lang="ZH-CN" style="font-family: "新細明體","serif";">主辦單位</span><span lang="ZH-CN"> </span><span lang="ZH-CN" style="font-family: "新細明體","serif";">國家生技醫療產業策進會</span><span lang="ZH-CN"> </span><span lang="ZH-CN" style="font-family: "新細明體","serif";">陳維昭会長</span><span lang="EN-US"> :</span><span lang="ZH-CN" style="font-family: "新細明體","serif";">因為竹北生醫園區的延宕,看到以前的人員在大陸已升為主任很感慨。</span></div><div class="MsoNormal"><br />
</div><div class="MsoNormal"><span lang="ZH-CN" style="font-family: "新細明體","serif";">台灣生技醫療產業發展趨勢與展望</span><span lang="EN-US"> </span><span lang="ZH-CN" style="font-family: "新細明體","serif";">蕭萬長副總統</span><span lang="ZH-CN"> </span><span lang="ZH-CN" style="font-family: "新細明體","serif";"> </span></div><div class="MsoNormal"><span lang="EN-US">Bio is the industry with big potential. high investment but huge potential; inevitable path for Taiwan as hotspot industry. 13 % growth and population aging concern.</span></div><div class="MsoNormal"><span lang="EN-US">global 8.8 bil usd.only 1% share will be 5 times of current size.Too much focus on IT in Taiwan.</span></div><div class="MsoNormal"><span lang="EN-US">leverage other advantages like ICT or capital.</span></div><div class="MsoNormal"><span lang="EN-US">24 bil NTD to help grow the industry. Superincubator (SCI).</span></div><div class="MsoNormal"><span lang="EN-US">IPO 2010 46 companies ; NTD 30 bil investment.</span></div><div class="MsoNormal"><br />
</div><div class="MsoNormal"><span lang="ZH-CN" style="font-family: "新細明體","serif";">台灣生技醫療產業面臨之挑戰與政府施政策略</span><span lang="EN-US"> </span><span lang="ZH-CN" style="font-family: "新細明體","serif";">行政院朱敬一政務委員</span></div><div class="MsoNormal"><br />
</div><div class="MsoNormal"><span lang="EN-US">1.Policy</span></div><div class="MsoNormal"><span lang="EN-US">Taiwan unique potential: </span></div><div class="MsoNormal"><span lang="EN-US">Colony lead to the best talent in medicine industry or physicians</span></div><div class="MsoNormal"><span lang="EN-US">Biggest Chinese database from reimbursement system.</span></div><div class="MsoNormal"><span lang="EN-US">Already invested in med. 15 bil NTD a year</span></div><div class="MsoNormal"><span lang="EN-US">Clinical trials recognized by big pharma. not only OEM but project leaders. Good upstream results.28 IND passed out of 66 Taiwan new drug. good research not very targeted or followed.</span></div><div class="MsoNormal"><span lang="EN-US">international licensing </span></div><div class="MsoNormal"><br />
</div><div class="MsoNormal"><span lang="EN-US">Good cases:</span><span lang="ZH-CN" style="font-family: "新細明體","serif";"> </span><span lang="EN-US">Scinopharm, Taigen, TTY</span></div><div class="MsoNormal"><br />
</div><div class="MsoNormal"><span lang="EN-US">Taiwan VC as active as Israel. Capital not a issue.</span></div><div class="MsoNormal"><br />
</div><div class="MsoNormal"><span lang="EN-US">ECFA Ch. 3 popular by foreign companies.</span></div><div class="MsoNormal"><span lang="EN-US">Regulation is different from IT.good gateway to China if harmolization.</span></div><div class="MsoNormal"><span lang="EN-US">Taiwan products or services with NAFTA model will be more valuable.</span></div><div class="MsoNormal"><br />
</div><div class="MsoNormal"><span lang="EN-US">Challenges:</span></div><div class="MsoNormal"><span lang="EN-US">Patents from Taiwan are increamental and related to manufacturing; </span></div><div class="MsoNormal"><span lang="EN-US">highly regulated industry; </span></div><div class="MsoNormal"><span lang="EN-US">Focused too much on OEM; </span></div><div class="MsoNormal"><span lang="EN-US">Most RD from academy in advanced countries. Taiwan is not systematical.</span></div><div class="MsoNormal"><br />
</div><div class="MsoNormal"><span lang="EN-US">Taiwan breakthrough: lab to phase 2. Not necessary to see low success rate in new drug RD. It is up to good talent while average success rate is low.</span></div><div class="MsoNormal"><br />
</div><div class="MsoNormal"><span lang="EN-US">Translation 4 players: </span></div><div class="MsoNormal"><span lang="EN-US">DCB, TFDA, BVC and SIC (platform: legal, deal, patent...as COO)</span></div><div class="MsoNormal"><br />
</div><div class="MsoNormal"><span lang="EN-US">EIU Taiwan is top 2 only lower than Sweden in world sanity ranking. </span></div><div class="MsoNormal"><span lang="EN-US">Last chance for Taiwan bio. </span></div><div class="MsoNormal"><span lang="EN-US">Taiwan had confidence in some industries but food and auto car failed and only ICT (<span class="st">Integrated Circuit Technology, </span>semiconductor) has been successful. </span></div><div class="MsoNormal"><br />
</div><div class="MsoNormal"><span lang="EN-US">Insight</span></div><div class="MsoNormal"><br />
</div><div class="MsoNormal"><span lang="ZH-CN" style="font-family: "新細明體","serif";">經建會與國發基金推動生技醫療產業發展之政策與方針</span><span lang="EN-US"> </span><span lang="ZH-CN" style="font-family: "新細明體","serif";">經濟建設委員會胡仲英副主委</span></div><div class="MsoNormal"><span lang="EN-US">BVC</span></div><div class="MsoNormal"><span lang="EN-US">first bio investment was in 1984 GBC</span></div><div class="MsoNormal"><span lang="EN-US">Scinopharm, Taigen, </span><span lang="ZH-CN" style="font-family: "新細明體","serif";">中裕</span><span lang="EN-US"> record breaking in licensing</span></div><div class="MsoNormal"><span lang="EN-US">BVC evaluation procedure</span></div><div class="MsoNormal"><span lang="ZH-CN" style="font-family: "新細明體","serif";">生技鑽石行動方案</span></div><div class="MsoNormal"><span lang="EN-US">3 out 5 submitted BP. TMF project passed; 20% fund</span></div><div class="MsoNormal"><span lang="EN-US">Burrill capital fund IV</span></div><div class="MsoNormal"><br />
</div><div class="MsoNormal"><span lang="EN-US">2 focuses: Device and drug;</span></div><div class="MsoNormal"><span lang="EN-US">subindustry not fixed</span></div><div class="MsoNormal"><span lang="EN-US">how to attract good VC? Actually Taiwan VC is like Israel. eg TSMC is the success case.</span></div><div class="MsoNormal"><br />
</div><div class="MsoNormal"><span lang="ZH-CN" style="font-family: "新細明體","serif";">施振栄</span><span lang="ZH-CN"> </span><span lang="EN-US">smile curve but marketing is difficult for bio</span></div><div class="MsoNormal"><br />
</div><div class="MsoNormal"><span lang="ZH-CN" style="font-family: "新細明體","serif";">從</span><span lang="EN-US">TMF</span><span lang="ZH-CN" style="font-family: "新細明體","serif";">談台灣醫療器材產業競爭力之提升</span><span lang="EN-US"> Vertical Group Partner </span></div><div class="MsoNormal"><span lang="EN-US">TMF (Taiwan Medtech Fund) </span><span lang="ZH-CN" style="font-family: "新細明體","serif";">張有德博士</span></div><div class="MsoNormal"><br />
</div><div class="MsoNormal"><br />
</div>Anonymoushttp://www.blogger.com/profile/00641862248583269952noreply@blogger.com0tag:blogger.com,1999:blog-16131226.post-36338985973203041242011-08-08T14:32:00.002+08:002011-08-08T14:32:56.532+08:00Global GMP guidelines available online<!--[if gte mso 9]><xml> <w:WordDocument> <w:View>Normal</w:View> <w:Zoom>0</w:Zoom> <w:TrackMoves/> <w:TrackFormatting/> <w:PunctuationKerning/> <w:DisplayHorizontalDrawingGridEvery>0</w:DisplayHorizontalDrawingGridEvery> <w:DisplayVerticalDrawingGridEvery>2</w:DisplayVerticalDrawingGridEvery> <w:ValidateAgainstSchemas/> <w:SaveIfXMLInvalid>false</w:SaveIfXMLInvalid> <w:IgnoreMixedContent>false</w:IgnoreMixedContent> <w:AlwaysShowPlaceholderText>false</w:AlwaysShowPlaceholderText> <w:DoNotPromoteQF/> <w:LidThemeOther>EN-US</w:LidThemeOther> <w:LidThemeAsian>ZH-TW</w:LidThemeAsian> <w:LidThemeComplexScript>X-NONE</w:LidThemeComplexScript> <w:Compatibility> <w:SpaceForUL/> <w:BalanceSingleByteDoubleByteWidth/> <w:DoNotLeaveBackslashAlone/> <w:ULTrailSpace/> <w:DoNotExpandShiftReturn/> <w:AdjustLineHeightInTable/> <w:BreakWrappedTables/> <w:SnapToGridInCell/> <w:WrapTextWithPunct/> <w:UseAsianBreakRules/> <w:DontGrowAutofit/> <w:SplitPgBreakAndParaMark/> <w:DontVertAlignCellWithSp/> <w:DontBreakConstrainedForcedTables/> <w:DontVertAlignInTxbx/> <w:Word11KerningPairs/> <w:CachedColBalance/> </w:Compatibility> <w:BrowserLevel>MicrosoftInternetExplorer4</w:BrowserLevel> <m:mathPr> <m:mathFont m:val="Cambria Math"/> <m:brkBin m:val="before"/> <m:brkBinSub m:val="--"/> <m:smallFrac m:val="off"/> <m:dispDef/> <m:lMargin m:val="0"/> <m:rMargin m:val="0"/> <m:defJc m:val="centerGroup"/> <m:wrapIndent m:val="1440"/> <m:intLim m:val="subSup"/> <m:naryLim m:val="undOvr"/> </m:mathPr></w:WordDocument> </xml><![endif]--><!--[if gte mso 9]><xml> <w:LatentStyles DefLockedState="false" DefUnhideWhenUsed="true"
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<div class="MsoNormal"><br />
</div><div class="MsoNormal"><span lang="EN-US">Singapore, Aug 05, 2011: For manufacturers who must comply with current good manufacturing practice (GMP) keeping track of the latest guidelines can be time consuming and difficult. This task is considerably more complex if the manufacturer exports to multiple countries, each with their own GMP requirements.</span></div><div class="MsoNormal"><br />
</div><div class="MsoNormal"><span lang="EN-US">PharmOut, a professional consultancy specializing in GMP compliance, has created an online database of GMP guidelines. This database, available at <b><u><span style="color: red;"><a href="http://gmp.pharmout.net/">http://gmp.pharmout.net</a></span></u></b>, is free to access and allows the user to search across all English language GMP guidelines, past and present. </span></div><div class="MsoNormal"><br />
</div><div class="MsoNormal"><span lang="EN-US">"Take the example of a penicillin manufacturer," said Mr Trevor Schoerie, PharmOut's Managing Director. "If they export to multiple countries and they are planning a change to their facility, they would have to go to each country's regulatory website, download the appropriate GMP guidelines and then search each document. Using the online GMP Library, they can do one search - across all the GMP guidelines. Our consultants have been using this powerful tool for some time and we are now making it available to the industry. The GMP Library makes it easy for manufacturers to determine the highest GMP standard they must comply with, across the countries they ship to."</span></div><div class="MsoNormal"><br />
</div><div class="MsoNormal"><span lang="EN-US">Mr Bob Tribe, former chairman of the Pharmaceutical Inspection Cooperative Scheme (PICS), said, "Regulators recognize that globalization and outsourcing have redrawn the path that drugs navigate to reach the end consumer. The supply chain from manufacturer to consumer has become complex, involving a global web of intermediaries. Companies within this supply chain must keep up to date with the GMP requirements of all the countries they supply to. Whilst harmonization of GMP requirements is certainly making compliance simpler, tools like PharmOut's searchable GMP library will be invaluable for those who must comply with multiple GMP requirements."</span></div><div class="MsoNormal"><br />
</div><div class="MsoNormal"><span lang="EN-US">The GMP library is kept up to date with monthly checks to ensure the documents are current. Each document is flagged with the date of the last check.</span></div>Anonymoushttp://www.blogger.com/profile/00641862248583269952noreply@blogger.com0tag:blogger.com,1999:blog-16131226.post-46231060968040616212011-05-09T10:00:00.001+08:002011-05-09T10:00:53.711+08:00台湾トウ聯が台湾で開発した抗体を生産する動物細胞を使用し、日本で抗体製造プロセスを担う。<!-- https://twitter.com/#!/TaiPeiZin/status/67408209866014721 --> <style type='text/css'>.bbpBox67408209866014721 {background:url(http://a0.twimg.com/profile_background_images/153007742/Taiwan_daily_news_taiwan_map2.jpg) #EDECE9;padding:20px;} p.bbpTweet{background:#fff;padding:10px 12px 10px 12px;margin:0;min-height:48px;color:#000;font-size:18px !important;line-height:22px;-moz-border-radius:5px;-webkit-border-radius:5px} p.bbpTweet span.metadata{display:block;width:100%;clear:both;margin-top:8px;padding-top:12px;height:40px;border-top:1px solid #fff;border-top:1px solid #e6e6e6} p.bbpTweet span.metadata span.author{line-height:19px} p.bbpTweet span.metadata span.author img{float:left;margin:0 7px 0 0px;width:38px;height:38px} p.bbpTweet a:hover{text-decoration:underline}p.bbpTweet span.timestamp{font-size:12px;display:block}</style> <div class='bbpBox67408209866014721'><p class='bbpTweet'>【台湾】三菱ガス化、抗体医薬に参入:台湾トウ聯と提携[医薬]/NNA.ASIA <a href="http://t.co/XD3hwfZ" rel="nofollow">http://t.co/XD3hwfZ</a><span class='timestamp'><a title='Mon May 09 01:59:04 +0000 2011' href='https://twitter.com/#!/TaiPeiZin/status/67408209866014721'>less than a minute ago</a> via <a href="http://twitter.com/tweetbutton" rel="nofollow">Tweet Button</a> <a href='http://twitter.com/intent/favorite?tweet_id=67408209866014721'><img src='http://si0.twimg.com/images/dev/cms/intents/icons/favorite.png' /> Favorite</a> <a href='http://twitter.com/intent/retweet?tweet_id=67408209866014721'><img src='http://si0.twimg.com/images/dev/cms/intents/icons/retweet.png' /> Retweet</a> <a href='http://twitter.com/intent/tweet?in_reply_to=67408209866014721'><img src='http://si0.twimg.com/images/dev/cms/intents/icons/reply.png' /> Reply</a></span><span class='metadata'><span class='author'><a href='http://twitter.com/TaiPeiZin'><img src='http://a3.twimg.com/profile_images/1318263583/___.jpg_normal.jpg' /></a><strong><a href='http://twitter.com/TaiPeiZin'>台湾原薬Taiwan Genyaku </a></strong><br />
TaiPeiZin</span></span></p></div><!-- end of tweet -->Anonymoushttp://www.blogger.com/profile/00641862248583269952noreply@blogger.com0tag:blogger.com,1999:blog-16131226.post-53237223413592336282011-05-09T09:52:00.002+08:002011-05-09T09:55:32.341+08:00台湾東洋<!-- https://twitter.com/#!/TaiPeiZin/status/67403353809883136 --> <style type='text/css'>.bbpBox67403353809883136 {background:url(http://a0.twimg.com/profile_background_images/153007742/Taiwan_daily_news_taiwan_map2.jpg) #EDECE9;padding:20px;} p.bbpTweet{background:#fff;padding:10px 12px 10px 12px;margin:0;min-height:48px;color:#000;font-size:18px !important;line-height:22px;-moz-border-radius:5px;-webkit-border-radius:5px} p.bbpTweet span.metadata{display:block;width:100%;clear:both;margin-top:8px;padding-top:12px;height:40px;border-top:1px solid #fff;border-top:1px solid #e6e6e6} p.bbpTweet span.metadata span.author{line-height:19px} p.bbpTweet span.metadata span.author img{float:left;margin:0 7px 0 0px;width:38px;height:38px} p.bbpTweet a:hover{text-decoration:underline}p.bbpTweet span.timestamp{font-size:12px;display:block}</style> <div class='bbpBox67403353809883136'><p class='bbpTweet'>タンパク医薬工場 台湾東洋巨資蓋廠 揮軍蛋白質藥 <a href="http://bit.ly/jMyAbB" rel="nofollow">http://bit.ly/jMyAbB</a><span class='timestamp'><a title='Mon May 09 01:39:46 +0000 2011' href='https://twitter.com/#!/TaiPeiZin/status/67403353809883136'>less than a minute ago</a> via <a href="http://www.tweetdeck.com" rel="nofollow">TweetDeck</a> <a href='http://twitter.com/intent/favorite?tweet_id=67403353809883136'><img src='http://si0.twimg.com/images/dev/cms/intents/icons/favorite.png' /> Favorite</a> <a href='http://twitter.com/intent/retweet?tweet_id=67403353809883136'><img src='http://si0.twimg.com/images/dev/cms/intents/icons/retweet.png' /> Retweet</a> <a href='http://twitter.com/intent/tweet?in_reply_to=67403353809883136'><img src='http://si0.twimg.com/images/dev/cms/intents/icons/reply.png' /> Reply</a></span><span class='metadata'><span class='author'><a href='http://twitter.com/TaiPeiZin'><img src='http://a3.twimg.com/profile_images/1318263583/___.jpg_normal.jpg' /></a><strong><a href='http://twitter.com/TaiPeiZin'>台湾原薬Taiwan Genyaku </a></strong><br/>TaiPeiZin</span></span></p></div><!-- end of tweet -->Anonymoushttp://www.blogger.com/profile/00641862248583269952noreply@blogger.com0tag:blogger.com,1999:blog-16131226.post-77604235928521860202011-04-20T10:55:00.003+08:002011-04-20T13:51:53.924+08:00わかもと台湾Yung Shinと9月末に合弁会社設立MOU的合作內容是永信可分工製造Wakomoto的部份中間體。然後Wakamoto協助永信進入日本市場。目前Wakomoto也會持續經營原有的癲癇藥和維他命, 但產品線不會和新公司競爭。<br />
<br />
<br />
Yung Shin(YSP, 永信藥品)が台湾での初めてPIC/S GMP製薬会社という。FDAとPMDAによって承認されているYSPは台湾に本社を置き、医療用医薬品やOTC、栄養補助食品等を製造・販売している大手企業。取り扱うジェネリック医薬品の品目数は400~500品目。従業員数は約1100人、売上規模は約170億円です。<br />
<div style="background-color: transparent; border: medium none; color: black; overflow: hidden; text-align: left; text-decoration: none;"><a href="http://nownews.com/2011/04/18/91-2705775.htm#ixzz1K1sDqNH1" style="color: #003399;"></a></div><br />
<h3><a href="http://www.mixonline.jp/Article/tabid/55/artid/40664/Default.aspx">わかもと 台湾企業と9月末に合弁会社設立 日本でジェネリック製造販売へ</a></h3><br />
<div style="background-color: transparent; border: medium none; color: black; overflow: hidden; text-align: left; text-decoration: none;">原文網址: <a href="http://nownews.com/2011/04/18/91-2705775.htm#ixzz1K1pZPKGr" style="color: #003399;">永信、日本WAKAMOTO成立合資公司 進軍日學名藥市場 | 頭條新聞 | NOWnews 今日新聞網</a> <a href="http://nownews.com/2011/04/18/91-2705775.htm#ixzz1K1pZPKGr" style="color: #003399;">http://nownews.com/2011/04/18/91-2705775.htm#ixzz1K1pZPKGr</a></div><h3> </h3>Anonymoushttp://www.blogger.com/profile/00641862248583269952noreply@blogger.com0tag:blogger.com,1999:blog-16131226.post-61181487386465373452011-04-07T17:26:00.000+08:002011-04-07T17:26:48.007+08:00關西地區的製藥業<div class="separator" style="clear: both; text-align: center;"><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEiCEHO8WujyuZnoTL2OxAe9c7eivGo5VFp-oFmiSDdZY8pznYUl6nrg4EAsmDOkYiiLxBhaKh_zA360q2m8e-UujcEz6vwKC1uh_zhWVoppTh-rMyHtOr8RO6RYmz6eEBEKDM3R/s1600/temp.jpg" imageanchor="1" style="margin-left: 1em; margin-right: 1em;"><img border="0" height="241" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEiCEHO8WujyuZnoTL2OxAe9c7eivGo5VFp-oFmiSDdZY8pznYUl6nrg4EAsmDOkYiiLxBhaKh_zA360q2m8e-UujcEz6vwKC1uh_zhWVoppTh-rMyHtOr8RO6RYmz6eEBEKDM3R/s320/temp.jpg" width="320" /></a></div>Anonymoushttp://www.blogger.com/profile/00641862248583269952noreply@blogger.com0tag:blogger.com,1999:blog-16131226.post-91355121814212650082011-01-20T11:23:00.000+08:002011-01-20T11:29:04.272+08:00TFDA Review 2011.1.17《食品藥物管理局藥品藥政業務之回顧與展望說明會之講義內容》<span id="GridView1_ctl02_lcontent" class="contentstyle"><br /><a href="http://www.cde.org.tw/fileupload/news/1000117/%E9%84%92%E7%B5%84%E9%95%B7-%E6%88%91%E5%9C%8B%E8%97%A5%E5%93%81%E8%97%A5%E6%94%BF%E6%94%B9%E9%9D%A9%E7%AD%96%E7%95%A5%E5%8F%8A%E5%B0%87%E4%BE%86%E5%AF%A9%E6%9F%A5%E6%96%B0%E5%88%B6%E8%AA%AA%E6%98%8E.pdf" target="_blank"> 鄒組長-我國藥品藥政改革策略及將來審查新制說明</a><br /><a href="http://www.cde.org.tw/fileupload/news/1000117/%E4%B8%80%E7%A7%91-%E8%97%A5%E5%93%81%E5%AE%89%E5%85%A8%E8%A9%95%E4%BC%B0%E6%A5%AD%E5%8B%99.pdf" target="_blank">一科-藥品安全評估業務</a><br /><a href="http://www.cde.org.tw/fileupload/news/1000117/%E4%BA%8C%E7%A7%91-%E6%96%B0%E5%8C%96%E5%AD%B8%E8%97%A5%E5%93%81%E5%AF%A9%E6%9F%A5%E6%A5%AD%E5%8B%99%E4%B9%8B%E5%9B%9E%E9%A1%A7%E8%88%87%E5%B1%95%E6%9C%9B.pdf" target="_blank">二科-新化學藥品審查業務之回顧與展望</a><br /><a href="http://www.cde.org.tw/fileupload/news/1000117/%E4%B8%89%E7%A7%91-%E5%AD%B8%E5%90%8D%E8%97%A5%E5%93%81%E5%AF%A9%E6%9F%A5%E6%A5%AD%E5%8B%99%E4%B9%8B%E5%9B%9E%E9%A1%A7%E8%88%87%E5%B1%95%E6%9C%9B.pdf" target="_blank">三科-學名藥品審查業務之回顧與展望</a><br /><a href="http://www.cde.org.tw/fileupload/news/1000117/%E5%9B%9B%E7%A7%91-%E7%94%9F%E7%89%A9%E8%97%A5%E5%93%81%E5%8F%8A%E6%96%B0%E8%88%88%E7%94%9F%E6%8A%80%E8%97%A5%E5%93%81%E5%AF%A9%E6%9F%A5%E6%A5%AD%E5%8B%99%E4%B9%8B%E5%9B%9E%E9%A1%A7%E8%88%87%E5%B1%95%E6%9C%9B.pdf" target="_blank">四科-生物藥品及新興生技藥品審查業務之回顧與展望</a><br /><a href="http://www.cde.org.tw/fileupload/news/1000117/%E4%BA%94%E7%A7%91-%E8%97%A5%E5%93%81%E8%87%A8%E5%BA%8A%E8%A9%A6%E9%A9%97%E6%A5%AD%E5%8B%99%E6%88%90%E6%9E%9C%E8%88%87%E5%B1%95%E6%9C%9B.pdf" target="_blank">五科-藥品臨床試驗業務成果與展望</a><br /><a href="http://www.cde.org.tw/fileupload/news/1000117/%E5%85%AD%E7%A7%91-1-%E8%97%A5%E4%BA%8B%E4%BA%BA%E5%93%A1%E7%B9%BC%E7%BA%8C%E6%95%99%E8%82%B2.pdf" target="_blank">六科-1-藥事人員繼續教育</a><br /><a href="http://www.cde.org.tw/fileupload/news/1000117/%E5%85%AD%E7%A7%91-2-%E8%97%A5%E5%B8%AB%E7%AE%A1%E7%90%86%E8%88%87%E8%97%A5%E4%BA%8B%E6%9C%8D%E5%8B%99%E6%A5%AD%E5%8B%99%E5%9B%9E%E9%A1%A7%E8%88%87%E5%B1%95%E6%9C%9B.pdf" target="_blank">六科-2-藥師管理與藥事服務業務回顧與展望</a></span>Anonymoushttp://www.blogger.com/profile/00641862248583269952noreply@blogger.com0tag:blogger.com,1999:blog-16131226.post-38176436629971125322010-10-07T04:16:00.004+08:002010-10-07T04:39:36.810+08:00CPhI WW 2010 Paris: Étude Op. 10, No. 12, RevolutionaryCPhIでショパンの<span class="status-body"><span class="status-content"><span class="entry-content">練習曲第12番 ハ短調:</span></span></span>「革命」<br /><br /><iframe allowfullscreen='allowfullscreen' webkitallowfullscreen='webkitallowfullscreen' mozallowfullscreen='mozallowfullscreen' width='320' height='266' src='https://www.blogger.com/video.g?token=AD6v5dx3hVkI3jWarLmZcMkXq_9-1hqg5Is7kvmXytuVIuKNqmQi_ilogc9svUoWOEW-DRzXxfIAS5AQ8cs' class='b-hbp-video b-uploaded' frameborder='0'></iframe>Anonymoushttp://www.blogger.com/profile/00641862248583269952noreply@blogger.com2tag:blogger.com,1999:blog-16131226.post-45794284997196714242010-09-27T09:55:00.002+08:002010-09-27T09:58:38.894+08:00Japan GMP 2007 (108 pages)1. 変更管理システムに関する提言;<br />2. Science and Regulatory Studies at National Institute of Health Sciences;<br />3. Current Japanese Regulations and Implementation of ICH Q8-Q10;<br /><br /><br /><iframe title="Preview" marginheight="0" marginwidth="0" style="width: 98px; height: 115px; padding: 0pt; background-color: rgb(252, 252, 252);" src="http://cid-36cacf53da5f165e.office.live.com/embedicon.aspx/.Public/H19GMPguideline3.pdf" scrolling="no" frameborder="0"></iframe>Anonymoushttp://www.blogger.com/profile/00641862248583269952noreply@blogger.com0tag:blogger.com,1999:blog-16131226.post-40871917373552566452010-05-10T09:07:00.000+08:002010-05-10T09:10:02.236+08:00CPHI Worldwide 2010<span class="Apple-style-span" style="font-family: 'Trebuchet MS', Tahoma, Helvetica, sans-serif; font-size: small; "><p style="margin-top: 1.2em; margin-bottom: 1.2em; padding-top: 0px; padding-bottom: 0px; font-size: small; "></p><span><span>The CPHI event was first held in 1990 and 2010 marks the 21st year of this prominent and industry-leading occasion. From just 250 delegates at the initial convention, visitor numbers have steadily grown from more than a few hundred visitors to well over 25,000 people. Hosting over 1,400 exhibitors, the event now covers more than 50,000 square meters of exposition space. Regarding global pharmaceuticals ingredients, it is the main promotion leader in the industry.</span></span></span><div><span class="Apple-style-span" style="font-family: 'Trebuchet MS', Tahoma, Helvetica, sans-serif; font-size: small; "><span><span>This important event gives customers of the industry a chance to meet various manufacturers and discuss their products. Medicine has come a long way and the world is learning more each day. Medical professionals today have the privilege of being able to make the best choices and feel confident in making decisions regarding drugs.</span></span></span></div><div><span class="Apple-style-span" style="font-family: 'Trebuchet MS', Tahoma, Helvetica, sans-serif; font-size: small; "><span><span>There are many reasons to attend the CPHI Worldwide Event, of course, but it helps to know that visitors from over 125 countries will be attending and this creates a matchless environment where delegates can gather, study, and share thoughts with each other. The wide-range of exhibitors allows visitors to renew existing acquaintances as well as establish new marketable associations. Every year, over 95% of visitors make new business acquaintances and leads. With both recognized businesses and new participants exhibiting, visitors have access to key pharmaceutical ingredients represented by professionals from around the globe, as well as fast-moving and emerging new markets. CPHI includes a conference agenda, speaker’s area, an industry awards presentation and a series of specialist events.</span></span></span></div><div><span class="Apple-style-span" style="font-family: 'Trebuchet MS', Tahoma, Helvetica, sans-serif; font-size: small; "><span><span><br /></span></span></span></div><div><span class="Apple-style-span" style="font-family: 'Trebuchet MS', Tahoma, Helvetica, sans-serif; font-size: small; "><span><span><a href="http://www.cphi.com/">http://www.cphi.com/</a></span></span></span></div><div><span class="Apple-style-span" style="font-family:'Trebuchet MS', Tahoma, Helvetica, sans-serif;"><span class="Apple-style-span" style="font-size: small;"><br /></span></span></div>Anonymoushttp://www.blogger.com/profile/00641862248583269952noreply@blogger.com0tag:blogger.com,1999:blog-16131226.post-14613411263543282712010-04-20T13:34:00.001+08:002010-04-20T13:36:33.948+08:00Visit to India Companies<div>来週インドの製薬会社へ</div><div><br /></div><a onblur="try {parent.deselectBloggerImageGracefully();} catch(e) {}" href="http://image.movapic.com/pic/m_201004201416244bcd38a8e5dce.jpeg"><img style="float:left; margin:0 10px 10px 0;cursor:pointer; cursor:hand;width: 640px; height: 538px;" src="http://image.movapic.com/pic/m_201004201416244bcd38a8e5dce.jpeg" border="0" alt="" /></a><div><span class="Apple-style-span" style="color:#0000EE;"><u><br /></u></span></div><div><a onblur="try {parent.deselectBloggerImageGracefully();} catch(e) {}" href="http://image.movapic.com/pic/m_201004201416244bcd38a8e5dce.jpeg"></a><span class="Apple-style-span" style="color:#0000EE;"><u><br /></u></span><br /></div>Anonymoushttp://www.blogger.com/profile/00641862248583269952noreply@blogger.com1tag:blogger.com,1999:blog-16131226.post-8443494459232176202010-04-19T13:56:00.001+08:002010-04-19T13:59:21.790+08:00TFDA Chief speech TFDA局長康照洲 (mp3)<div>2010.4.15</div><div><br /></div><div><span class="Apple-style-span" style=" color: rgb(99, 64, 71); line-height: 21px; font-family:'Lucida Grande', sans-serif;font-size:25px;"><a href="http://twaud.io/SVM" class="tweet-url web" rel="nofollow" target="_blank" style="margin-top: 0px; margin-right: 0px; margin-bottom: 0px; margin-left: 0px; padding-top: 0px; padding-right: 0px; padding-bottom: 0px; padding-left: 0px; text-decoration: underline; color: rgb(130, 8, 68); ">http://twaud.io/SVM</a></span></div><div><br /></div><div><span><span></span></span><span class="Apple-style-span" style="font-family: Verdana, Arial, Helvetica, sans-serif; font-size: 15px; color: rgb(65, 65, 65); line-height: 24px; -webkit-border-horizontal-spacing: 3px; -webkit-border-vertical-spacing: 3px; ">兩岸醫藥交流自去年10月由國家生技醫療產業策進會率團拜會大陸衛生部後,雙方都期待在今年的江陳會能簽署實質醫藥協議,為了這項共識,衛生署藥物食品管理局(TFDA)局長康照洲已計劃4月底拜會大陸國家食品藥品監督管理局(SFDA)局長邵明立。</span></div>Anonymoushttp://www.blogger.com/profile/00641862248583269952noreply@blogger.com0tag:blogger.com,1999:blog-16131226.post-41769963259528556202010-03-31T10:39:00.001+08:002010-03-31T10:41:53.942+08:00Ranbaxy, Pfenex ties up for Biosimilar Therapeutic development<div><span class="Apple-style-span" style="font-family: 'MS PGothic', 'Hiragino Kaku Gothic Pro', 'ヒラギノ角ゴ Pro W3', Arial, Helvetica, sans-serif; line-height: 24px; "><span><span>インドの製薬最大手ランバクシー・ラボラトリーズ(500359.BY)は29日、バイオシミラーの治療用タンパク質を米フィーネックス(Pfenex、本社:カリフォルニア州)と共同で開発する契約を締結したと発表した。</span></span></span></div><div><span class="Apple-style-span" style="font-family: 'MS PGothic', 'Hiragino Kaku Gothic Pro', 'ヒラギノ角ゴ Pro W3', Arial, Helvetica, sans-serif; line-height: 24px; "><span><span><br /></span></span></span></div><div><span class="Apple-style-span" style="font-family: arial; font-size: 12px; color: rgb(51, 51, 51); "></span></div><span><span>Ranbaxy Laboratories Limited and Pfenex Inc. announced that Ranbaxy will develop an undisclosed biosimilar therapeutic produced in the Pfēnex Expression Technology™ platform, a Pseudomonas-based recombinant protein expression technology.</span></span><div><span class="Apple-style-span" style="font-family: arial; font-size: 12px; color: rgb(51, 51, 51); "><br /></span></div><div><a href="http://www.indiainfoline.com/Markets/News/Ranbaxy-Pfenex-ties-up-for-Biosimilar-Therapeutic-development/4804638377">http://www.indiainfoline.com/Markets/News/Ranbaxy-Pfenex-ties-up-for-Biosimilar-Therapeutic-development/4804638377</a></div>Anonymoushttp://www.blogger.com/profile/00641862248583269952noreply@blogger.com0tag:blogger.com,1999:blog-16131226.post-69010552617601307262010-03-31T09:43:00.006+08:002010-03-31T10:02:10.806+08:00Fire Burns Savior Lifetec Factory, Causing $7Mln Loss<div><span class="Apple-style-span" style="font-family: 'MS Pゴシック'; font-size: 14px; line-height: 25px; "><span><span><a href="http://ejje.weblio.jp/content/%E3%82%AB%E3%83%AB%E3%83%90%E3%83%9A%E3%83%8D%E3%83%A0%E7%B3%BB%E6%8A%97%E7%94%9F%E7%89%A9%E8%B3%AA" title="カルバペネム系抗生物質の英訳" class="crosslink" style="font-size: 14px; line-height: 1.8em; border-bottom-color: rgb(255, 0, 0); border-bottom-style: solid; border-bottom-width: 1px; text-decoration: none; "><span class="Apple-style-span" style="color:#000000;"><span><span>カルバペネム系抗生物質</span></span></span></a>メーカーが火事</span></span></span></div><div><span class="Apple-style-span" style="font-family: 'MS Pゴシック'; font-size: 14px; line-height: 25px; "><span><span><br /></span></span></span></div><div>Savior Lifetec is a Taiwanese manufacturer of <span class="Apple-style-span" style=" ;font-family:'Arial Unicode MS';">carbapenem antibiotics. The fire in the morning of Mar 30th caused USD 7 million loss.</span></div><div><span class="Apple-style-span" style=" ;font-family:'Arial Unicode MS';"><br /></span></div><div><a href="http://udn.com/NEWS/SOCIETY/SOC2/5507761.shtml">火事写真</a></div><div><br /></div><div><span class="Apple-style-span" style=" color: rgb(105, 105, 105); font-family:Verdana, Arial, Helvetica, sans-serif;font-size:12px;"></span></div><span><span>【聯合報╱記者胡蓬生/竹南報導】</span></span><div><span><span><br /></span></span></div><div><span><span>苗栗縣竹南科學園區展旺生命科技公司,昨天上午發生火警,大火延燒逾2小時,不斷發生爆炸,巨大火球和濃煙直竄,火勢在10時後逐漸控制,這起火災是竹南園區成立近10年來最嚴重的,廠商損失估計超過2億元以上,但實際財務損失,展旺仍估算中。苗栗縣消防局今天到火場鑑識,調查火警原因。</span></span><div><span class="Apple-style-span" style=" color: rgb(65, 65, 65); line-height: 24px; -webkit-border-horizontal-spacing: 3px; -webkit-border-vertical-spacing: 3px; font-family:Verdana, Arial, Helvetica, sans-serif;font-size:15px;"></span></div></div><div><span><span><br /></span></span></div><div><span><span><a href="http://udn.com/NEWS/SOCIETY/SOC2/5507761.shtml">News in Chinese</a></span></span></div><div><span class="Apple-style-span" style="color:#551A8B;"><span class="Apple-style-span" style="color:#000000;"><br /></span></span></div><div><span><span><span class="Apple-style-span" style="color: rgb(85, 26, 139); -webkit-text-decorations-in-effect: underline; "><br /></span></span></span></div>Anonymoushttp://www.blogger.com/profile/00641862248583269952noreply@blogger.com0tag:blogger.com,1999:blog-16131226.post-86701517222656045682010-03-30T08:54:00.006+08:002010-04-11T20:34:58.057+08:00The First 2 Biosimilars (Follow on Biologicals) in Japan<div></div><span><span><div><span><span>Please refer to the new Regulation on Biosimilar in Mar 2009. (Japanese)</span></span><span class="Apple-style-span" style=" line-height: 19px; font-family:arial, sans-serif;font-size:medium;"></span></div></span></span><div><div><div><iframe title="Preview" scrolling="no" marginheight="0" marginwidth="0" frameborder="0" style="width:98px;height:115px;padding:0;background-color:#fcfcfc;" src="http://cid-36cacf53da5f165e.skydrive.live.com/embedicon.aspx/.Public/2005I210304007.pdf"></iframe></div><div><br /></div><div>There are 2 products in the market now: </div><div><span><span><div><span><span><br /></span></span></div>1. The first biosimilar in Japan was Sandoz' Somatropin BS. (<a href="http://www.genengnews.com/news/bnitem.aspx?name=64624116">English news</a>)</span></span><div><span><span><br />The Novartis generics business, Sandoz, launched its recombinant human growth hormone somatropin, Somatropin BS S.C., in Japan. The company says the drug is the first ever biosimilar to be approved and launched in that country, which represents the world’s second largest pharma market. </span></span></div><div></div><span><span><div><span><span><br /></span></span></div></span></span><span><span>2. Nippon Chemical Research's EPO was the second biosimilar approved in Japan. (2010 Jan)</span></span></div><div><br /></div><div><span><span></span></span></div><span><span>Reference:<br /><a href="http://www.ge-academy.org/img/academic_jounal_sample/vol3-1/GE3-1smp_p71.pdf">バイオ後続品の品質・安全性・有効性確保のための指針</a></span></span></div><div><span><br /></span></div><div><span><span></span></span><span><span><a href="http://www.mhlw.go.jp/shingi/2009/11/dl/s1104-7l.pdf">バイオ後続品について</a></span></span></div><div><br /></div><div><a href="http://wwwhourei.mhlw.go.jp/hourei/doc/tsuchi/T100406I0020.pdf">質疑応答集</a> (2010.3.31)<br /><div><div><span><span><br /><a href="http://www.nature.com/nbt/journal/v27/n11/fig_tab/nbt1109-963a_T1.html">Biosimilars approval status worldwide</a></span></span><div><br /><span class="Apple-style-span" style=" line-height: 19px; font-family:arial, sans-serif;font-size:medium;"><a href="http://www.dir.co.jp/souken/research/report/emg-inc/biz-model/10030101biz-model.pdf" class="l" style="font-family: arial, sans-serif; color: rgb(85, 26, 139); ">動き出す<em style="color: rgb(204, 0, 51); font-style: normal; font-weight: normal; text-decoration: underline; ">バイオ後続品</em>市場</a></span><div><span class="Apple-style-span" style="font-family:arial, sans-serif;"><span class="Apple-style-span" style="line-height: 19px; font-size:medium;"><br /></span></span></div><div><a href="http://www.dir.co.jp/souken/research/report/emg-inc/biz-model/10030101biz-model.pdf" class="l" style="color: rgb(85, 26, 139); "></a><span class="Apple-style-span" style="font-family:arial, sans-serif;"><span class="Apple-style-span" style="line-height: 19px; font-size:medium;"><span class="Apple-style-span" style=" ;font-size:small;"><h3 class="r" style="font-size: medium; font-weight: normal; padding-top: 0px; padding-right: 0px; padding-bottom: 0px; padding-left: 0px; margin-top: 0px; margin-right: 0px; margin-bottom: 0px; margin-left: 0px; display: inline; "><a href="http://www.jpwa.or.jp/kinyaku/diexmple/img/DI20090812.pdf" class="l" style="font-family: arial, sans-serif; color: rgb(85, 26, 139); ">学術 Q&A Q <em style="color: rgb(204, 0, 51); font-style: normal; font-weight: normal; text-decoration: underline; ">バイオ後続品</em>とは何ですか</a></h3></span></span></span></div><div><span class="Apple-style-span" style="font-family:arial, sans-serif;"><span class="Apple-style-span" style="line-height: 19px; font-size:medium;"><span class="Apple-style-span" style=" ;font-size:small;"><br /></span></span></span></div></div></div></div></div></div>Anonymoushttp://www.blogger.com/profile/00641862248583269952noreply@blogger.com0tag:blogger.com,1999:blog-16131226.post-2701914252036931172010-03-26T10:51:00.003+08:002010-05-06T20:01:14.581+08:00日欧米三極におけるGMP【システム】査察とGMP体制の違い<div></div><span><span><span class="Apple-style-span" style="font-family:'Lucida Grande', sans-serif;font-size:100%;color:#666666;"><span class="Apple-style-span" style=" line-height: 14px;font-size:12px;"><span class="Apple-style-span" style="color: rgb(0, 0, 0); line-height: normal; font-family:Georgia, serif;font-size:16px;"><span><span>It has been my interest to know the difference of GMP systems among USA, EU and Japan.</span></span> </span></span></span></span></span><div><span><span><span class="Apple-style-span" style="font-family:'Lucida Grande', sans-serif;font-size:100%;color:#666666;"><span class="Apple-style-span" style=" line-height: 14px;font-size:12px;"><span class="Apple-style-span" style="font-family:Georgia, serif;font-size:130%;color:#000000;"><span class="Apple-style-span" style=" line-height: normal;font-size:16px;"><br /></span></span></span></span></span></span></div><div>According to Mr Yasumoto:</div><div><br /></div><div><div><div>" The impression was that PMDA (Japanese authorities) is not as demanding as FDA. However, PMDA seems to be very strict for biopharmaceuticals and analytical procedures. PIC/s is similar to WHO and FDA, while some particular analytical methods are required."</div><div><br /><!-- http://twitter.com/Atsu_4/status/11037107159 --> <style type="text/css">.bbpBox{background:url(http://s.twimg.com/a/1273086425/images/themes/theme9/bg.gif) #1A1B1F;padding:20px;}p.bbpTweet{background:#fff;padding:10px 12px 10px 12px;margin:0;min-height:48px;color:#000;font-size:18px !important;line-height:22px;-moz-border-radius:5px;-webkit-border-radius:5px}p.bbpTweet span.metadata{display:block;width:100%;clear:both;margin-top:8px;padding-top:12px;height:40px;border-top:1px solid #fff;border-top:1px solid #e6e6e6}p.bbpTweet span.metadata span.author{line-height:19px}p.bbpTweet span.metadata span.author img{float:left;margin:0 7px 0 0px;width:38px;height:38px}p.bbpTweet a:hover{text-decoration:underline}p.bbpTweet span.timestamp{font-size:12px;display:block}</style> <div class="bbpBox"><p class="bbpTweet">@<a class="tweet-url username" href="http://twitter.com/Asian_API" rel="nofollow">Asian_API</a> 日本のPMDAはFDAのシステム査察よりは甘い印象がある反面、バイオ医薬や試験法には非常に厳格なイメージがあります。PIC/SはWHOとFDAとほぼ同じですが、一部独自の試験法が要求されている感じ。でしょうか?140字だとなかなか説明は難しいですね。<span class="timestamp"><a title="Thu Mar 25 14:42:33 +0000 2010" href="http://twitter.com/Atsu_4/status/11037107159">less than a minute ago</a> via <a href="http://www.hootsuite.com/" rel="nofollow">HootSuite</a></span><span class="metadata"><span class="author"><a href="http://twitter.com/Atsu_4"><img src="http://a1.twimg.com/profile_images/429164108/060825_134105_normal.jpg" /></a><strong><a href="http://twitter.com/Atsu_4">Atsushi Yasumoto</a></strong><br />Atsu_4</span></span></p></div> <!-- end of tweet --><br /></div><div>参考:FDAとEMEAの相違点 <a href="http://www.jstage.jst.go.jp/article/pda/9/1/42/_pdf">査察官特別講演p48</a></div><div><br /></div><div>In EU, Germany has special regulation for biological /fermentation products while other European countries don't. Still, fermentation products like statins or immunosuppressants are not as difficult as protein drugs. </div><div><br /></div></div></div>Anonymoushttp://www.blogger.com/profile/00641862248583269952noreply@blogger.com0tag:blogger.com,1999:blog-16131226.post-63690716175217873092010-03-18T14:54:00.004+08:002010-03-18T15:23:37.906+08:00Taiyo Pharmaceutical Plant to be shutdown for 10 days<div><span class="Apple-style-span" style="font-family: arial, sans-serif; font-size: small; line-height: 19px; "><em style="color: rgb(204, 0, 51); font-style: normal; font-weight: normal; "><span><span>大洋薬品高山工場</span></span></em></span></div><div><br /></div><div><span class="Apple-style-span" style="font-family: arial, sans-serif; font-size: small; line-height: 19px; "><em style="color: rgb(204, 0, 51); font-style: normal; font-weight: normal; "></em></span>28,500 cartons of Famotidine 20mg were delivered in April~Sep 2009. But the assay was OOS. </div><div><br /></div><div>The government ruled that operaton of Takayam plant should be held for 10 days from Mar 26th. </div><div><br /></div><div><a href="http://www.yakuji.co.jp/entry18556.html">http://www.yakuji.co.jp/entry18556.html</a></div><div><br /></div><div><a href="http://www.seikiken.or.jp/activity/enterprise/kengaku/repo_kengaku31-2.pdf">高山工場見学</a></div><div><br /></div>Anonymoushttp://www.blogger.com/profile/00641862248583269952noreply@blogger.com0tag:blogger.com,1999:blog-16131226.post-83377921569162792552010-03-15T10:26:00.002+08:002010-03-15T10:28:28.173+08:00APIs Export More than Dosages in 2009<div>The news from Taiwan</div><div><span class="Apple-style-span" style=" ;font-family:Arial;font-size:medium;"><table width="100%" border="0" cellspacing="3" cellpadding="0"><tbody><tr><td width="76%"><div class="story_title" id="story_title" style="font-family: Verdana, Arial, Helvetica, sans-serif; font-size: 16px; line-height: 18px; font-weight: bold; color: rgb(255, 128, 0); float: left; padding-top: 9px; ">我國原料藥出口值高於西藥製劑</div><br /></td></tr></tbody></table><table width="100%" border="0" cellpadding="0" cellspacing="3"><tbody><tr><td width="130%" background="http://udn.com/1024/images/linedot.gif"></td></tr><tr><td><table width="100%" border="0" cellspacing="0" cellpadding="0"><tbody><tr><td width="75%" class="story_author" style="font-family: Verdana, Arial, Helvetica, sans-serif; font-size: 11px; color: rgb(105, 105, 105); "><div id="story_author">【經濟日報╱記者謝柏宏/即時報導】</div></td><td width="25%" class="story_author" style="font-family: Verdana, Arial, Helvetica, sans-serif; font-size: 11px; color: rgb(105, 105, 105); "><div align="right" id="story_update">2010.02.26 11:21 pm</div></td></tr></tbody></table></td></tr><tr><td class="story_author" style="font-family: Verdana, Arial, Helvetica, sans-serif; font-size: 11px; color: rgb(105, 105, 105); "> </td></tr><tr><td valign="top"><div class="story" id="story" style="font-family: Verdana, Arial, Helvetica, sans-serif; font-size: 11pt; line-height: 18pt; color: rgb(65, 65, 65); "><p>ITIS公布98年第四季及全年製藥產業發展,原料藥出口值高於西藥製劑。</p><p>ITIS指出,歷年來我國製藥產業的出口多以西藥製劑為主,但2008年原料藥的出口值已超越了西藥製劑,使得我國原料藥開始呈現貿易順差。</p><p>推估2009年全年我國原料藥的出口較2008年同期成長6.8%,為新台幣51.9億元;反觀西藥製劑,則一直呈現貿易逆差,2009年全年出口值為新台幣48.6億元。</p><p></p></div><p class="story" style=" line-height: 18pt; color: rgb(65, 65, 65); font-family:Verdana, Arial, Helvetica, sans-serif;font-size:11pt;"><span id="source_name" class="story" style=" line-height: 18pt; color: rgb(65, 65, 65); font-family:Verdana, Arial, Helvetica, sans-serif;font-size:11pt;">【2010/02/26 經濟日報】</span><span class="author" style=" color: rgb(105, 105, 105); font-family:Verdana, Arial, Helvetica, sans-serif;font-size:11px;"><a href="http://udn.com/" target="_blank" style="color: rgb(65, 65, 65); font-style: normal; text-decoration: none; ">@ </a><a href="http://udn.com/" target="_blank" style="color: rgb(65, 65, 65); font-style: normal; text-decoration: none; ">http://udn.com/</a></span> </p></td></tr></tbody></table></span></div>Anonymoushttp://www.blogger.com/profile/00641862248583269952noreply@blogger.com0tag:blogger.com,1999:blog-16131226.post-27578036810090750772010-02-23T11:41:00.001+08:002010-02-23T11:41:47.888+08:00Taiyo's commercial to promote Generics<object width="425" height="344"><param name="movie" value="http://www.youtube.com/v/gy75tEwlmco&hl=zh_TW&fs=1&"></param><param name="allowFullScreen" value="true"></param><param name="allowscriptaccess" value="always"></param><embed src="http://www.youtube.com/v/gy75tEwlmco&hl=zh_TW&fs=1&" type="application/x-shockwave-flash" allowscriptaccess="always" allowfullscreen="true" width="425" height="344"></embed></object>Anonymoushttp://www.blogger.com/profile/00641862248583269952noreply@blogger.com0tag:blogger.com,1999:blog-16131226.post-81253506189579229632009-12-29T10:39:00.002+08:002009-12-29T10:42:50.492+08:00Taiwan biotech: FDA - Taiwanese-styleAnonymoushttp://www.blogger.com/profile/00641862248583269952noreply@blogger.com0