2006/8/12

Generics and BE

 
Generic Versus Pioneer Product
Equivalence Concepts (CFR 320)
 Pharmaceutical Equivalence
Same active ingredient
 Same strength
 Same dosage form and route of administration
 Comparable labeling
 Meet compendial or other standards of identity,
strength, quality, purity and potency
 Bioequivalence
 In vivo measurement of active moiety (moieties)
in biologic fluid (blood/urine)
 In vivo pharmacodynamic comparison
 In vivo clinical comparison
 In vitro comparison
 Other
THEN: THERAPEUTIC EQUIVALENCE

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