Malaysian Guideline For The Conduct Of Bioavailability And Bioequivalence Studies

  • General Information

The guideline was published in the year of 2000 based on similar contents from “Note For Guidance On The Investigation of Bioavailability And Bioequivalence”, which is  a standard set of guidelines outlined especially for The European Agency for the Evaluation of Medicinal Products (EMEA, 1998). However, some adaptation has been made for Malaysian application. The objective of the guideline is to define products with  systemic effect where  bioavailability (BA) and bioequivalence (BE) studies are necessary as well as to formulate requirements for their design, conduct and evaluation. It serves as  guide to the local researchers in conducting Bioavailability and Bioequivalence  Studies (BA/BE) in accordance to established international ethical guidelines  and scientific standards. The guideline also provides detailed definitions on the terms such as pharmaceutical equivalence, pharmaceutical alternatives, bioavailability, bioequivalence, essentially similar products and therapeutic equivalence. The core topics in the guideline relate to design and  how studies are to be conducted. It also highlights the necessity to submit BA/BE studies  for new  and  approved active substances (1).

 

  • Contact Details

National Pharmaceutical Control Bureau (NPCB)
Biro Pengawalan Farmaseutikal Kebangsaan
Lot 36, Jalan Universiti
46200 Petaling Jaya,Selangor Darul Ehsan, Malaysia
Tel: +603-7883 5400
Fax: +603-7956 2924, +603-7956 7075
Website: http://www.bpfk.gov.my


Reference:

  1. National Pharmaceutical Control Bureau (NPCB). Guidelines; Malaysian guidelines for the conduct of bioavailability and bioequivalence studies. Malaysia: Ministry of Health Malaysia; 2000 Sep 14 [cited 2012 Oct 29]. Available from: http://portal.bpfk.gov.my/index.cfm?menuid=51&parentid=50