Biowaiver Monographs for Immediate Release Solid Oral Dosage Forms: Diclofenac Sodium and Diclofenac Potassium

Author:

B.Chuasuwan ,Binjesoh V.,Polli J.E.,Zhang H.,Amidon G.L.,Junginger H.E.,Midha K.K.,Shah V.P.,Stavchansky S.,Dressman J.B.,Barends D.M.

Publisher

Elsevier BV

Subject

Pharmaceutical Science

Reference71 articles.

1. Biowaiver monographs for immediate release solid oral dosage forms based on biopharmaceutics classification system (BCS) literature data: Verapamil hydrochloride, propranolol hydrochloride, and atenolol;Vogelpoel;J Pharm Sci,2004

2. WHO. 2006. 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. Available from URL http://healthtech.who.int/pq/info3_general/documents/TRS937/WHO_TRS_937_annex8_eng.pdf

3. U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER). 2000. Guidance for industry: Waiver of in vivo bioavailability and bioequivalence studies for immediate-release solid oral dosage forms based on a Biopharmaceutics Classification System. Available from URL http://www.fda.gov/cder/guidance/3618fnl.pdf.

4. Committee for Proprietary Medicinal Products (CPMP). 2007. Concept paper on BCS-based biowaiver. Available from URL http://www.emea.europa.eu/pdfs/human/ewp/21303507en.pdf

5. Biowaiver monographs for immediate release solid oral dosage forms: Acetaminophen (paracetamol);Kalantzi;J Pharm Sci,2006

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