Biowaiver Monographs for Immediate Release Solid Oral Dosage Forms: Piroxicam

Author:

Shohin Igor E.,Kulinich Julia I.,Ramenskaya Galina V.,Abrahamsson Bertil,Kopp Sabine,Langguth Peter,Polli James E.,Shah Vinod P.,Groot D.W.,Barends Dirk M.,Dressman Jennifer B.

Publisher

Elsevier BV

Subject

Pharmaceutical Science

Reference79 articles.

1. World Health Organization (WHO).Proposal to waive in vivo bioequivalence requirements for WHO Model List of Essential Medicines immediate-release, solid oral dosage forms;Technical Report Series, No 937, 40th Report, Annex 8 of WHO Expert Committee on Specifications for Pharmaceutical Preparations,2006

2. U.S. Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research (CDER);Guidances for industry: Waiver of in vivo bioavailability and bioequivalence studies for immediate-release solid oral dosage forms based on a Biopharmaceutics Classification System,2000

3. European Medicines Agency (EMA), Committee for Medicinal Products of Human Use (CHMP);Guidance on the Investigation of Bioequivalence,2010

4. International Pharmaceutical Federation (FIP);Biopharmaceutics Classification System (BCS),2009

5. World Health Organization (WHO);Guidance on INN,1997

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