NIFDS seeking to ensure bioequivalence of generic drugs
Published: 2013-05-28 06:56:00
Updated: 2013-05-28 06:56:00
The National Institute of Food and Drug Safety Evaluation (NIFDS) plans to introduce a regulation that a generic drug manufacturers must provide a full description of the bioequivalence testing results related to a generic product, such as pharmacokinetic profiles (AUC and Cmax), to ensure the fi...
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