Guidelines on Bioequivalence

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ASEAN Guideline for The Conduct of Bioequivalence Studies

The 22nd ASEAN Consultative Committee for Standards and Quality Pharmaceutical Product Working Group (ACCSQ-PPWG) meeting held on 09th -13th March 2015 in Vientiane,Lao PDR has endorsed the 4th draft of 1st revision for ASEAN Guideline for The Conduct of Bioequivalence Studies.

This latest guideline is adopted from the Guideline on the Investigation of Bioequivalence” (European Medicines Agency, London, 20 January 2010, CPMP/EWP/QWP/1401/98 Rev 1) with some adaptation for ASEAN application.

Malaysia has fully adopted this guideline since March 2015 and it is the most current guide for the conduct of bioequivalence studies.This guideline is to be read in conjunction with all relevant directives, circulars and updates regarding bioavailability and bioequivalence studies.
Malaysian Guidance on Biopharmaceutics Classification System (BCS) - Based Biowaiver

Effective from 1st March 2013, a biowaiver may be granted for generic immediate release oral solid dosage form products containing BCS Class I active ingredients listed in the Guidance On Biopharmaceutics Classification System (BCS) – Based Biowaiver documents. BCS Based biowaiver takes the three major factors that govern the rate and extent of drug absorption from immediate-release solid dosage forms into account i.e solubility and permeability of the drug substance/ active pharmaceutical ingredient (API), and dissolution characteristics of the drug product. This BCS approach provides an opportunity to waive in vivo pharmacokinetic bioequivalence testing for certain categories of immediate-release drug products.

Malaysian Guidance on Biopharmaceutics Classification System (BCS) - Based Biowaiver guideline is adopted mainly from the following guidelines to suit local requirements:

Guideline On The Investigation Of Bioequivalence (European Medicines Agency, London, 20 January 2010, CPMP/EWP/QWP/1401/98 Rev. 1/Corr)
Annex 7: Multisource (generic) pharmaceutical products: guidelines on registration requirements to establish interchangeability (World Health Organization (WHO), Technical Report Series, No 937, 2006)
Annex 8: Proposal to waive in vivo bioequivalence requirements for WHO Model List of Essential Medicines immediate-release, solid oral dosage forms (World Health Organization (WHO), Technical Report Series, No 937, 2006)

Previous BE Guidance Document:

    These two guidances/guidelines were adopted by Malaysia before March 2015 and are no longer in use.

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