BCS & IVIVC Based Biowaivers

The objective of this track is to suggest the Biowaivers potential of Biopharmaceutical classification system which is known to increase the solubility, dissolution, oral absorption of water insoluble drugs. Biopharmaceutics Classification System and Invitro and Invivo classification discusses about ADME pathways of different drugs. This track also includes BCS biowaivers, in vitro diffusion cells for dissolution testing in formulation development, in vitro preclinical ADME/BCS testing. Until in vitro in vivo correlation achieves the required degree, the Biosimilar drug will not be able to meet the needs of the original drug candidate. Hence the proportion of BCS and IVIVC based biowaivers are fairly low ~0.5-1% of total pharmaceutical products.

 

  • 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

Related Conference of BCS & IVIVC Based Biowaivers

August 20-21, 2018

12th Asian Biologics and Biosimilars Congress

Tokyo, Japan
August 29-30, 2018 |

International Conference and Exhibition on Drug Safety & Pharmacovigilance

Park Inn By Radisson, Toronto, Canada
October 18-20, 2018

18th World Pharma Congress

Warsaw, Poland
November 14-15, 2018

13th International Conference on Biosimilars and Biologics

Lisbon, Portugal
September 18-19, 2018

6 th European Biopharma Congress

Amsterdam, Netherlands

BCS & IVIVC Based Biowaivers Conference Speakers

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