Generic Versus Pioneer Product
Equivalence Concepts (CFR 320)
Pharmaceutical Equivalence
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
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
沒有留言:
張貼留言