Biowaiver monographs for immediate release solid oral dosage forms based on biopharmaceutics classification system (BCS) literature data: Verapamil hydrochloride, propranolol hydrochloride, and atenolol

Author:

Vogelpoel H.,Welink J.,Amidon G.L.,Junginger H.E.,Midha K.K.,Möller H.,Olling M.,Shah V.P.,Barends D.M.

Publisher

Elsevier BV

Subject

Pharmaceutical Science

Reference58 articles.

1. A theoretical basis for a Biopharmaceutics Drug Classification: The correlation of in vitro drug product dissolution and in vivo bioavailability;Amidon;Pharm Res,1995

2. Guidance for industry: Waiver of in vivo bioavailability and bioequivalence studies for immediate-release solid oral dosage forms based on a Biopharmaceutics Classification System,2006

3. Note for guidance on the investigation of bioavailability and bioequivalence.,2001

4. Martindale. The extra pharmacopoeia, 31st edn. Royal Pharmaceutical Society, London, UK: Royal Pharmaceutical Society, London.

5. European Directorate for the Quality of Medicines. European pharmacopoeia, 4th edn. Strasbourg, France: European Directorate for the Quality of Medicines, Council of Europe, Strasbourg, France.

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