Guide to BA/BE Centres in Malaysia
Opportunities for Bioavailability and Bioequivalence Studies in Malaysia
Many drug patents have recently expired or are scheduled to expire in the near future. As a result, many drug manufacturers have expanded their generic drug portfolio, which requires them to conduct bioavailability/bioequivalence (BA/BE) studies that demonstrate that their generic equivalents perform similarly to the innovator drug product. Bioinequivalence and variations in the bioavailability of generics can result in therapeutic failure and/or toxicity, further stressing the importance of developing standards for bioequivalence and bioavailability testing.
In Malaysia, five local BE centres (total of nine clinical and four bioanalytical sites) are listed in the National Pharmaceutical Control Bureau (NPCB) Compliance Programme for Bioequivalence Centres. Located in the major urban centres of Penang, Selangor/Kuala Lumpur and Kuching, these centres are well placed to recruit sufficient numbers of volunteer participants.
Malaysia is the first country in ASEAN to perform inspection and certification for BE centres locally and abroad. This is to ensure that BE studies being conducted satisfy the stipulated Malaysian regulatory requirements as well as international guidelines. These conditions have to be met before a generic product will be registered in Malaysia.
Malaysia’s competitive edge for the conduct of BA/BE studies lies in the strong support from the government, stringent drug regulatory policies, diverse genetic pool of human subjects, hospital-based clinical sites, and bioanalytical sites that comply with the OECD GLP (Organisation for Economic Cooperation and Development Good Laboratory Practice) principles.
In 2014, BA/BE studies contributed almost one third of the total number of Industry Sponsored Research (ISR) clinical trials conducted in Malaysia. (more statistics presented on pages 7 & 8)
This “Guide to BA/BE Centres in Malaysia” showcases the country’s capabilities in conducting these studies in well-equipped facilities, supported by experienced investigators and research team, as well as laboratories with state-of-the-art equipment for bioanalysis. These are the very foundation required for the conduct of high quality BA/BE studies.
