Regulated bioanalysis and the desire for harmonized regulations in China


“…there is a great desire for the bioanalytical laboratories in China to follow the same harmonized bioanalytical regulation if possible.” As the pharmaceutical market has become truly global in the last decade, so have the R&D activities for innovative drugs. Conducting both preclinical good laboratory practice (GLP) toxicology studies and clinical trials for new chemical entities (NCEs) in China has experienced a surge of interest in recent years, primarily due to the huge potential Chinese market, along with a perceived low cost. For foreign generic drug companies, the potential large cost saving for conducting bioequivalence (BE) studies in China has...

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