IVIVC Analysis Platform -Leadingpharm

Hemant P.Joshi

Chief scientist，General manager of IVIVR
Ph.D. in Rajiv Gandhi University of Health Science

● He was working as advanced scientist in several famous companies, such as Dr. Reddy‘s Laboratories and Sun pharmaceuticals and has almost 20-year-experience in clinical pharmacy and preparation R&D.

● He was involved in dozens of FDA, EMA registered ANDA, 505b(2) research and development work.

● He was involved in the pharmaceutical R&D and clinical program design of a number of 505b(2) innovative drugs and generic drugs, understanding of pharmacy and clinical practice.

Platform Introduction：

The platform is based on the company's chief scientist, Dr. Hemant P. Joshi, and combines the dissolution characteristics of the drug with the in vivo mechanism of action, modeling through a variety of software to predict in vivo behavior through in vitro data and provide support for pharmaceutical research and clinical research.

① According to the characteristics of the product, design the prescription process to find the exact dissolution conditions and evaluate whether the product can achieve the expected in vivo behavior.

② According to the in vitro dissolution behavior of the product, model and predict the in vivo behavior, and formulate a reasonable pre-BE plan.

③Analyze and interpret the results of pre-BE and BE, and give professional pharmacy and clinical evaluation conclusions. Among them, a thorough interpretation of pre-BE can evaluate and guide the development of prescription processes and guide the design of formal BE.

Platform achievement: Completed 200 oral solid preparation projects BE prediction and interpretation, the BE one-time pass rate is over 80%.

CMC

Platform Introduction：