BCS and IVIVC Based Biowaivers
Biopharmaceutics Classification System (BCS) and In Vitro-In Vivo Correlation (IVIVC) are regulatory frameworks used to assess the biowaivers for generic drug approval. BCS categorizes drugs based on their solubility and permeability, while IVIVC establishes a correlation between in vitro dissolution and in vivo pharmacokinetic profiles.
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