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

Helmut
★★★

Vienna, Austria,
2013-02-12 16:24
(4531 d 07:39 ago)

Posting: # 10004
Views: 7,499

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

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

jag009 ★★★ NJ, 2013-02-13 16:44 (4530 d 07:19 ago) @ Helmut Posting: # 10015 Views: 5,832	FDA: new guidances expected in 2013 Post reply
	Hi Helmut, ❝ Food-Effect Bioavailability and Fed Bioequivalence Studies—Bioavailability and Bioequivalence Studies for Orally Administered Drug Products Submitted in New Drug Applications. General Consideration Do I smell them bringing back a 3-way food effect study (Test Fed, Ref Fed, Test Fast)? John