Malaysian Guidelines for the Conduct of Bioavailability and Bioequivalence Studies, 2000
(2000; 28 pages)

Abstract

The Ministry of Health is constantly emphasising the quality, efficacy and safety of pharmaceutical products to safeguard the Malaysian public. With the increasing availability of generic products in the Malaysian market, it is imperative that the Ministry of Health introduce a mechanism to further ensure that generic products available are therapeutically equivalent to the innovator’s products and are clinically interchangeable. In practice, demonstration of bioequivalence (BE) is generally the most appropriate method of substantiating therapeutic equivalence between medicinal products. The objective of the “Malaysian Guidelines for the Conduct of Bioavailability and Bioequivalence Studies” is to ensure that BE studies in Malaysia are conducted according to the international ethical and scientific standards based on good science. The studies should be well designed and comply to Good Clinical Practice and Good Laboratory Practice. This guideline mainly adopts the basic principles outlined by The European Agency for the Evaluation of Medicinal Products (EMEA).

 
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