Samaya B
☆    

India,
2015-05-06 15:02
(3608 d 15:17 ago)

Posting: # 14759
Views: 2,727
 

 Draft guidance on BCS based biowaiver: FDA: May 2015 [Regulatives / Guidelines]

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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Draft guidance on Waiver of In Vivo Bioavailability and Bioequivalence Studies for Immediate-Release Solid Oral Dosage Forms Based on a Biopharmaceutics Classification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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