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CMC

Committed to the development and innovation of first-class drugs


 
        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.

 

 

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