Pharmacokinetic interaction study [Regulatives / Guidelines]

posted by Mahesh M – India, 2016-05-12 09:07 (3202 d 11:56 ago) – Posting: # 16296
Views: 4,200

Dear All,
My concern regarding Pharmacokinetic interaction study for new combination product, what are the criteria for passing (or how we can say not interact with each other) the Pharmacokinetic interaction study? Is it same as conventional Bioequivalence study criteria (90% CI 80 – 125%).

Please share If any guidance or literature available.

Thanks

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