Draft guidance on BCS based biowaiver: FDA: May 2015 [Regulatives / Guidelines]

posted by Samaya B – India, 2015-05-06 15:02 (4070 d 09:12 ago) – Posting: # 14759
Views: 3,232

Dear all,

Draft guidance on Waiver of In Vivo Bioavailability and Bioequivalence Studies for Immediate-Release Solid Oral Dosage Forms Based on a Biopharmaceutics Classification System: Guidance for Industry: May 2015 is available here:

http://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm070246.pdf


Regards,
Samaya

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