Japanese guidance on bioavailability and bioequivalence.
The guideline of bioequivalence tests for generic drugs in our country was recently revised (1), and guidelines for formulation change and different strengths were published in February 2000. This paper describes those guidelines briefly.
Aoyagi
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National Institute of Health Sciences, Tokyo, Japan.
D001682:Biological Availability; D002626:Chemistry, Pharmaceutical; D016568:Drugs, Generic / Q000493:pharmacokinetics* / Q000592:standards; D006801:Humans; D007564:Japan; D010599:Pharmacokinetics; D012106:Research; D013810:Therapeutic Equivalency
D016568:Drugs, Generic