IVIVR 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、 Empowering innovative medicines

① PK curve and efficacy prediction
② Accelerate clinical research(innovative drug data bridging, clinical trial exemptions)
③ Guiding clinical trial design (initial dose selection, dose selection for specific populations, dosing interval, food effects, drug-drug interactions)
2、Assisting generics drugs
① Virtual equivalence tests to assess the difference in quality between the test formulation and the reference formulation and clarify pharmaceutical goals
② Bioequivalence exemption data support
③ Interpretation of BE test results and optimization guidance.

CMC

Platform Introduction：