BCS Biowaivers

Drug developers and pharmaceutical companies can get the waiver of the clinical bioequivalence studies or biowaivers by using the Biopharmaceutics Classification System (BCS). BCS is a technical classification of drug substances based on their aqueous solubility and intestinal permeability. Along with this, during the dissolution testing, three major factors such as the rate and extent of absorption; dissolution, solubility and intestinal permeability are taken into account. Biowaivers refers to an authoritarian drug approval process when the drug is permitted based on proof of equivalence other than in vivo bioequivalence test. By using the BCS based biowaivers, we can eliminate the needless drug exposures to humans and decrease the economic difficulties, while in turn maintains the public health standard for beneficial equivalence.

According to BCS, drugs are categorized into four types
• Class I molecules include more Solubility, more Permeability
• Class II molecules include Less Solubility, more Permeability
• Class III molecules include more Solubility, Less Permeability
• Class IV molecules include Less Solubility, Less Permeability

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This page was last updated on April 19, 2024