BCS & IVIVC Based Biowaivers

In the era of swelling costs of drug development and shrinking budgets, the pharmaceutical industry has been striving hard to find ways for saving precious resources. Tools evolved through naive scientific probing, like BCS (Biopharmaceutics Classification System) and IVIVC (invitro and invivo classification) can act as the magic-wands in such cases. Besides obtaining biowaivers, IVIVC has been applied in drug delivery during various stages of development, like formulation screening, setting dissolution specifications and product development. Nonetheless, the most critical pharmaco-economic application is the biowaiver by avoidance of expensive clinical trials. Newer paradigms like in vitro/in vivo relationship (IVIVR) are also being deliberated and practiced at industrial level, esp. for IR formulations.

In the era of swelling costs of drug development and shrinking budgets, the pharmaceutical industry has been striving hard to find ways for saving precious resources. Tools evolved through naive scientific probing, like BCS (Biopharmaceutics Classification System) and IVIVC (invitro and invivo classification) can act as the magic-wands in such cases. Besides obtaining biowaivers, IVIVC has been applied in drug delivery during various stages of development, like formulation screening, setting dissolution specifications and product development. Nonetheless, the most critical pharmaco-economic application is the biowaiver by avoidance of expensive clinical trials. Newer paradigms like in vitro/in vivo relationship (IVIVR) are also being deliberated and practiced at industrial level, esp. for IR formulations.

  • BCS biowaivers
  • Preclinical and clinical testing for oral drug delivery
  • Waiver for In vivo bioavailability or bioequivalence
  • Consideration of biowaiver extensions for BCS class III drugs
  • In vitro diffusion cells for dissolution testing in formulation development
  • Dissolution testing in drug formulation
  • In vitro preclinical ADME/BCS testing
  • In vitro drug product research
  • Biowaiver approval for Biosimilars

Related Conference of BCS & IVIVC Based Biowaivers

June 08-09, 2018

7th International conference on Pharmaceutical Auditing

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4th International Conference on Drug Discovery, Designing and Development

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9th Asian Biologics and Biosimilars Congress

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18th World Pharma Congress

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8th World Congress Spectroscopy and Analytical Techniques

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6th European Biopharma Congress

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