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

Published: 2010-12-15 06:59:00

Updated: 2010-12-15 06:59:00

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 meth...

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