Items for comparative clinical trial to be waived from re-assessment of bioequivalence testing

Medicines which are designed to conduct a comparative clinical study with an original brand product will be exempted from the re-evaluation plan of bioequivalence testing, according to the Korea Food and Drug Administration.

The drug agency also said that officially unconfirmed validation method for isosorbide nitrate may be verified through re-evaluation of related bioequivalence data.

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