In Vitro Bioequivalence Analysis

The BASi Pharmaceutical Analysis group has 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 create the perfect match for our In Vitro services. BASi will leverage the FDA guidances and all applicable literature sources to develop a sound scientific, regulatory plan.

Services

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

Possible Generic Product Requiring In Vitro Bioequivalance Testing

• Sevelamer HCl
• Sevelamer carbonate
• Cholestyramine powder
• Colesevalam HCl
• Calcium Carbonate

Current Non-proprietary Methods Available

• Phosphate analysis by IC after binding study with Renegel®
• Phosphate analysis by IC after binding study with Renvela®
• Bile Acid analysis by HPLC after binding study with Welchol®
• Others in development

FDA Regulations
The Pharmaceutical Analysis Group routinely functions under cGMPs (21CFR210-211) and GLPs (21CFR58) which combined exceed the requirements for the In Vitro studies as defined in 21CFR320.

European Site Alternative
BASi UK has collaborated with the Pharmaceutical Analysis Group to jointly conduct studies outside the US.