Nikunj Patel
Dr. Nikunj Patel is a senior director of PBPK Consultancy Services in the Simcyp division of Certara. Nikunj helps clients with advanced PBPK modeling to expedite internal decision making, support biowaivers via virtual bioequivalence assessments, and develop model-informed regulatory strategies for novel products, generic formulations, scale-up and post-approval changes (SUPAC), and justification of dissolution specifications. He has more than more 13 years’ experience in computer-aided drug design and PKPD modeling, including 10+ years’ experience focusing on PBPK modeling.
Articles
Advancing Oral Drug Development Using MIFD
October 16th 2023Model informed formulation development uses in-silico modeling and simulation to identify and/or refine promising formulations faster and cheaper, support formulation strategy and increasingly, demonstrate virtual bioequivalence and obtain biowaivers.
