Glossary of Clinical Terms

Bioequivalence is a term used to describe the similarity between two pharmaceutical products containing the same active ingredient or therapeutic moiety. When two products are said to be bioequivalent, it means that they produce the same pharmacological effects in the body and have equivalent safety and efficacy profiles.

Bioequivalence is typically determined through a series of studies that compare the pharmacokinetics (absorption, distribution, metabolism, and elimination) of the two products in healthy volunteers or patients. The studies are designed to demonstrate that the two products are absorbed into the body at similar rates, reach the same concentration in the bloodstream, and are eliminated from the body at a similar rate.

The concept of Bioequivalence is particularly important in the field of generic drugs, where a generic drug is required to demonstrate bioequivalence to the innovator drug in order to be approved for use by regulatory authorities. By demonstrating bioequivalence, generic drugs can be considered interchangeable with the innovator drug, allowing patients to have access to more affordable treatments without compromising their safety or efficacy.

When determining Bioequivalence for the approval of generics, four probable instances are prevalent in practice:

1. The profiles of drug absorption are similar and equivalent therapeutically

2. The profiles of drug absorption differ, but they are equivalent therapeutically

3. The profiles of drug absorption are similar, but they are not equivalent therapeutically

4. The profiles of drug absorption differ, and they are not equivalent therapeutically.

Spring Bio Solution will be your perfect partner to source the comparator drugs needed to carry out the BA/BE studies. 

Write to us at sales@springbiosolution.com and book a 30-minute slot to discuss how we can work together.