BCS: implications on guidelines and policies for drug products approval world wide - Sponsored Whitepaper

The BCS attempts to identify when dissolution rate is likely to be rate-determining, and to assess when in-vitro/in-vivo correlations would be ex- pected. And that would be, of course, the Class I type of drug, where dissolution is rapid and not the rate-determining step, plasma levels may not reflect product differences, and little or no difference would be expected between oral solutions and solid dosage forms.