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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 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%.