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Biopharmaceutics Classification System (BCS) of Various Drug Substance

This guidance, issued by the Pharmacy and Poisons Board (PPB), provides a scientific and regulatory basis for classifying drug substances according to solubility and permeability to support regulatory decision-making, including requirements for bioequivalence studies and biowaivers.

Scope

This guidance applies to the  drug substances in products submitted for registration in Kenya where  BCS-classification may be considered in the context of bioequivalence study requirements and granting of biowaivers for certain classes of drugs

Main Content

• Biopharmaceutical Classification System– classification of drug substances into four classes:
  • Class I: High solubility, high permeability.
  • Class II: Low solubility, high permeability.
  • Class III: High solubility, low permeability.
  • Class IV: Low solubility, low permeability.
• Listing of drug substances according to the BCS Class.

Objective

This guidance aims to provide a structured framework for classifying drug substances based on solubility and permeability, in line with international regulatory practices.

Attached Files