Bioequivalence accomplishments, ongoing initiatives, and remaining challenges-Reference-Cited by-同舟云学术

Bioequivalence accomplishments, ongoing initiatives, and remaining challenges

Published:2013-07-11 Issue:1 Volume:37 Page:2-12
ISSN:0140-7783
Container-title:Journal of Veterinary Pharmacology and Therapeutics
language:en
Short-container-title:J. Vet. Pharmacol. Ther.

Author:

Martinez M. N.¹

Affiliation:

1. US Food and Drug Administration; Center for Veterinary Medicine; Rockville MD USA

Publisher

Wiley

Subject

General Veterinary,Pharmacology

Link

http://onlinelibrary.wiley.com/wol1/doi/10.1111/jvp.12063/fullpdf

Reference40 articles.

1. A theoretical basis for a biopharmaceutic drug classification: the correlation of in vitro drug product dissolution and in vivo bioavailability;Amidon;Pharmaceutical Research,1995

2. Annon1 2009 ICH harmonised tripartite guideline pharmaceutical development Q8(R2) http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Quality/Q8_R1/Step4/Q8_R2_Guideline.pdf

3. Annon2 2000 Waiver of in vivo bioavailability and bioequivalence studies for immediate-release solid oral dosage forms based on a biopharmaceutics classification system http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM070246.pdf

4. Annon3 2008 European medicines agency guideline on the investigation of bioequivalence http://www.emea.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500003011.pdf

5. Annon4 2012 Health Canada draft guidance document: biopharmaceutics classification based biowaiver http://www.hc-sc.gc.ca/dhp-mps/alt_formats/pdf/consultation/drug-medic/bcs_draft_guide_ebauche_ld_scb-eng.pdf

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