One product, process, set of specifications: A proven quality paradigm for the safety and efficacy of biologic drugs

One product, process, set of specifications: A proven quality paradigm for the safety and efficacy of biologic drugs

If the FDA changes the current policies that preclude "generic biological drugs," manufacturers of those products should be held to the same standards as the first manufacturers. Safe and effective biological products can be assured only by extensive characterization of each drug substance...

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Veröffentlicht in:Biopharm 2001-03, Vol.14 (3), p.14
Hauptverfasser: Copmann, Tom, Davis, Gregory, Garnick, Rob, Landis, John
Format: Artikel
Sprache:eng
Schlagworte:
Bioequivalence
Biological products
Biotechnology
Clinical trials
FDA approval
Federal regulation
Generic drugs
Insulin
Manufacturers
Manufacturing
Process controls
Product development
Proteins
Public health
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Zusammenfassung:If the FDA changes the current policies that preclude "generic biological drugs," manufacturers of those products should be held to the same standards as the first manufacturers. Safe and effective biological products can be assured only by extensive characterization of each drug substance and product, a well-defined and validated manufacturing process and appropriate clinical trials to establish the safety and efficacy for that molecule.
ISSN:1542-166X
1939-1862