Bioequivalence and Bioavailability Forum • FDA: new guidances expected in 2013

FDA: new guidances expected in 2013 [BE/BA News]

posted by Helmut – Vienna, Austria, 2013-02-12 16:24 (3946 d 08:18 ago) – Posting: # 10004
Views: 5,816

Dear all,

FDA published their Guidance Agenda for 2013. Interesting:

Food-Effect Bioavailability and Fed Bioequivalence Studies—Bioavailability and Bioequivalence Studies for Orally Administered Drug Products Submitted in New Drug Applications. General
Consideration
Submission of Clinical Pharmacology Data as Evidence of Biosimilarity for Biologics and Protein Products
Bioequivalence Studies with Pharmacokinetic Endpoints for Drug Products Submitted in Abbreviated New Drug Applications
Bioanalytical Methods Validation

—
Dif-tor heh smusma 🖖🏼 Довге життя Україна!
Helmut Schütz

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Science Quotes

FDA: new guidances expected in 2013Helmut 2013-02-12 15:24
- FDA: new guidances expected in 2013 jag009 2013-02-13 15:44