Francis Micheal, M. Pharm., Ph.D.

Areas of Expertise:

• Clinical Pharmacologist with over 23 years of experience and expertise in leading, managing clinical development related activities for multiple ANDAs for complex generics, generics, 505(b)(2)s, biosimilars and NDAs.
• Over couple of decade experience of effectively handling different external service providers in different geographies for the effective collaboration, planning, designing, execution of non-clinical & clinical studies for different regulatory agencies submission.
• Pharmacokinetics
• Clinical Operations
• In-Vitro In-Vivo Correlation (IVIVC)

Publications:

Over 20 manuscripts/ oral presentations in peer reviewed journals/ presented in a different reputed forum. Couple of recent publications are presented here.

• Has the Time Come to Employ Population and Individual Bioequivalence for the Evaluation of Generics? Francis Micheal, Mohanlal Sayana, Rajendra Prasad M, Balamurali MM, Current Drug Metabolism, 21(2), 2020, 112-125.
• Current Regulatory Standpoint on Evaluating the Bioequivalence of Different Classes of Generic Drugs - is the Evaluation in the Right Direction? Francis Micheal, Balamurali MM, Mohanlal Sayana, Current Drug Metabolism, 20(1), 2019, 835-844.