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

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