BCS & 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. The proportion of BCS and IVIVC based biowaivers are fairly low for pharmaceutical products. This classification can be used as a basis for setting in vitro dissolution specifications and can also provide a basis for predicting the likelihood of achieving a successful in vivo-in vitro correlation (IVIVC).

  • BCS biowaivers
  • Preclinical and clinical testing for oral drug delivery
  • In vitro preclinical ADME/BCS testing
  • In vitro drug product research
  • Dissolution testing in drug formulation

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