In Vitro Bioequivalence Testing

In Vitro Bioequivalence Testing determines the rate/extent of absorption of each therapeutic moiety. PolyCrystalLine’s testing of solid oral dosage forms is in accordance with ICH guidelines and is necessary for:

• Potential generic products for which there is an approved for marketing reference listed drug (RLD)
• Potential new products (new salts, dosage forms) for which adequate clinical studies have already been conducted
• Reformulated drug products

PolyCrystalLine’s In Vitro Bioequivalence Testing is GLP certified.

For more information or to discuss In Vitro Bioequivalence Testing please contact us directly.