The FDA's assessment of follow-on protein products: a historical perspective

The scientific and regulatory issues associated with the possible introduction of 'follow-on' versions of protein drug products are currently attracting much attention. Past examples are discussed of the FDA's actions involving the evaluation of various types of follow-on and second-g...

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Veröffentlicht in:	Nature reviews. Drug discovery 2007-06, Vol.6 (6), p.437-442
Hauptverfasser:	Woodcock, Janet, Griffin, Joseph, Behrman, Rachel, Cherney, Barry, Crescenzi, Terrie, Fraser, Blair, Hixon, Dena, Joneckis, Christopher, Kozlowski, Steven, Rosenberg, Amy, Schrager, Lewis, Shacter, Emily, Temple, Robert, Webber, Keith, Winkle, Helen
Format:	Artikel
Sprache:	eng
Schlagworte:	Albumins - standards Allergens Biomedical and Life Sciences Biomedicine Biotechnology Calcitonin - standards Cancer Research Drug Approval Drugs Epoetin Alfa Erythropoietin - standards Evaluation Hepatitis B Vaccines - standards Hyaluronoglucosaminidase - standards Medicinal Chemistry Methods Molecular Medicine opinion-2 Pharmacology/Toxicology Proteins - standards Recombinant Proteins - standards Services United States United States Food and Drug Administration
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