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In the past three decades, Chinas pharmaceutical market has grown to be the fifth largest in the world and is well positioned to be the second largest within the next decade.Many global pharmaceutical companies are setting their R&D centers in China.More and more global clinical studies and drug registration trials have been conducted in the country.Regulated bioanlaysis is playing more and more important role to support both regulated pre-clinical and clinical studies.Therefore it is extremely important for Chinese bioanalytical community and regulatory agency to understand and follow the trend of international bioanalytical guidance.In first part of this presentation, a historical review of the evolution of regulated bioanalysis around the world, along with the advancement of analytical technologies, will be given.The newest development and their indications in bioanalytical guidelines from FDA, EMA and industrial white papers in the past decade will be discussed.The presentation will also give the latest update on bioanalycal guidelines from Japan MHLW, Canada TPD, Brazil ANVISA and China SFDA/Pharmacopeia.The gaps between Chinese and FDA/EMA guidelines will be briefly compared.Then the current status, challenges and opportunities for regulated bioanalysis to support both GLP preclinical and clinical studies in China will be discussed.Finally I will give update on the on-going efforts to harmonize the bioanalytical guidance from global bioanalyticai communities-specifically the goals, current activities and the future impact of Global Bioanalytical Consortium (GBC) will be presented.