Clinical Pharmacology and Pharmacokinetics: Questions and Answers

On 25 May 2020 the EMA updated the Q&A document on clinical pharmacology and pharmacokinetics.

The EMA added a new Q&A to section 4.12, Clarification on demonstration of bioequivalence for dabigatran etexilate and updated the Q&A to section 7.1, key pharmacokinetic considerations in the assessment of biosimilarity.

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