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Clinical trials bridging studies

NR Cutler, JJ Sramek. Scientific and ethical concerns in clinical trials in Alzheimer s patients the bridging study. Eur J Clin Pharmacol 48 421-428, 1995. [Pg.792]

Foreign clinical results are acceptable except in areas where there are immunological and ethnic differences between Japanese and foreigners. The ethnic factors are divided into two components intrinsic factors such as racial factors and physiological differences and extrinsic factors, which include cultural and environmental issues. In these cases, the MHLW may require that some bridging comparative clinical trials be performed with dose ranging protocols. This will enable absorption, distribution, metabolism, and excretion studies to be carried out on Japanese individuals and provide better dosage and indication for the Japanese people. The MHLW also requires that application be accompanied by one year of real-time stability data and that sterility test results be included. [Pg.216]

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See also in sourсe #XX -- [ Pg.210 ]



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