Answer: True
The Biopharmaceutics Classification System (BCS) does indeed take into account dissolution, solubility, and intestinal permeability as the three major factors governing the rate and extent of drug absorption from immediate-release (IR) solid oral dosage forms. 1, 2
BCS Framework
The BCS was developed to provide a scientific approach for classifying drug compounds based on these three critical parameters 2:
- Solubility - assessed as related to dose 1, 2
- Intestinal permeability - membrane permeability characteristics 1, 2
- Dissolution - dissolution properties of the oral IR dosage form 2
How BCS Uses These Factors
The system categorizes drugs into one of four biopharmaceutical classes according to their water solubility and membrane permeability characteristics, which broadly allows prediction of the rate-limiting step in the intestinal absorption process following oral administration 1:
- Class I: High solubility, high permeability 3
- Class II: Low solubility, high permeability 3
- Class III: High solubility, low permeability 3
- Class IV: Low solubility, low permeability 3
Regulatory Application
The BCS has been effectively implemented by drug regulatory agencies worldwide in setting bioavailability/bioequivalence standards for IR oral drug product approval 1. The system provides a regulatory tool for replacing certain bioequivalence studies with accurate in vitro dissolution tests 2, 4.
Clinical Significance
One notable finding is that the clinical performance of the majority of approved IR oral drug products essential for human health can be assured with an in vitro dissolution test, rather than empirical in vivo human studies 1.