BCS and IVIVC Based Biowaivers

The objective of this work was to suggest the biowaivers potential of biopharmaceutical classification system which are 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 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 and IVIVC Based Biowaivers

August 10-12, 2017

8th Asian Biologics and Biosimilars Congress

Beijing, China
September 20-21, 2017

10th Pharmacovigilance Congress

Charlotte, North Carolina, USA
September 25-26, 2017(10 Plenary Forums- 1 Event)

7th International Conference and Exhibition on Pharmaceutical Regulatory Affairs and IPR

Chicago, Illinois, USA
September 25-26, 2017
(10 Plenary Forums - 1Event)

6th International Conference and Exhibition on GMP, GCP & Quality Control

Chicago, Illinois, USA
October 16-18, 2017

12th World Pharma Congress

Budapest, Hungary
October 16-18, 2017

11th World Drug Delivery Summit

(10 Plenary Forums - 1Event)
Baltimore, Maryland, USA
October 16-17, 2017

10th International Conference and Exhibition on Biologics and Biosimilars

San Francisco, California, USA
November 09-11, 2017

4th European Biopharma Congress

Vienna, Austria

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