In Vitro and In Vivo Bioequivalence Analysis

BASi® has proven experience and expertise with the FDA guidance documents and regulations on In Vitro Bioequivalence studies. The group's pharmaceutical product testing expertise mixed with the corporation's knowledge of bioequivalence studies and regulations creates the perfect match for our In Vitro services. BASi® leverages the FDA guidances and all applicable literature sources to develop a sound scientific, regulatory plan.

Services

  • Development assistance - comparative binding
  • Method development and validation
    • Innovator product
    • New material
  • BE study variable determination guidance
  • Equilibrium binding studies
  • Kinetic binding studies
  • Dissolution bioequivalence studies
  • Final report with electronic data to statisticians

Possible Generic Products Requiring In Vitro Bioequivalence Testing

  • Sevelamer HCl
  • Sevelamer carbonate
  • Lanthanum Carbonate
  • Cholestyramine powder
  • Colesevelam HCl
  • Colestipol HCl

FDA Regulations
The BASi team conducts all In Vitro studies as defined by FDA 21CFR320 and FDA product specific guidances.