Manager

Year Vadodara, Gujarat, India

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Literature search and study designing of Bioavailability and Bioequivalence studies of oral & non-oral products(injectable, Semisolids, TDS etc.) towards different regulatory submission.
Review of BA/BE study protocol and provide Pharmacokinetic (PK) inputs into the study protocols
Developing protocol for patient based PK end point & also for PD/Clinical end point BE studies for complex generics.
Perform PK and Statistical analysis of in-vivo data obtained from BA/BE and pharmacokinetics studies using Phoenix Software.
Coordinate with the CRO in India and outside India for finalizing biostudy pilot and pivotal study protocol for DCGI BE application.
Preparation of pharmacokinetic queries response, scientific justification for study design/ protocol/ results towards various regulatory agencies for their concurrance or advice.
Having in-depth understanding of in-vitro parameters and indentification of critical variables impacting the in-vivo release. Perform IVIVC, simulation and Pharmacokinetic modelling to improve BE success.

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