Biowaiver Monographs for Immediate Release Solid Oral Dosage Forms: Aciclovir

Author:

Arnal J.,Gonzalez‐Alvarez I.,Bermejo M.,Amidon G.L.,Junginger H.E.,Kopp S.,Midha K.K.,Shah V.P.,Stavchansky S.,Dressman J.B.,Barends D.M.

Publisher

Elsevier BV

Subject

Pharmaceutical Science

Reference76 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, No937, 40th Report, Annex 8 of WHO Expert committee on specifications for pharmaceutical preparations. Available from URLhttp://whqlibdoc.who.int/trs/WHO_TRS_937_eng.pdf.

3. FDA.2000.Waiver of In Vivo Bioavailability and Bioequivalence Studies for Immediate‐Release Solid Oral Dosage Forms Based on a Biopharmaceutics Classification System. Available from URLhttp://www.fda.gov/cder/guidance/3618fnl.pdf. ed.: U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER).

4. EMEA.2001.Note for guidance on the investigation of bioavailability and bioequivalence. Available from URLhttp://www.emea.eu.int/pdfs/human/ewp/140198en.pdf. ed.: Committee for Proprietary Medicinal Products (CPMP).

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

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