BIOEQUIVALENCE STUDY IN CLINICAL TRIAL

BIOEQUIVALENCE STUDY AND BIOAVAILABILITY STUDY UNDER CLINICAL TRIAL 

       Bioequivalence study is defined as the absence of a significant difference in the rate and extent to which the active ingredient or active moiety in pharmaceutical dosage form becomes available at the site of drug action when administered at the same molar dose under similar conditions in an appropriately designed study. The documentation belong to this study can be useful to establish links between (a) early and late clinical trial formulations; (b) formulations used in clinical trial and stability studies, if different;(c) clinical trial formulations and to-be-marketed drug product. Bioequivalence studies are critical component in the post-approval period for certain changes in new drug application (NDA).

Bioequivalence study

    Another term named bioavailability is most important approach in bioequivalence study design. Bioavailabilty means the rate and extent to which the active substance or therapeutic moiety is absorbed from a pharmaceutical form and becomes available at the site of action. In the major cases substances are intended to exhibit a systemic therapeutic effect, and a more practical definition can be given for taking into consideration that the substance in the general circulation is in exchange with the substance at the site of action.  

Bioavailability Study

      Bioequivalence of new drug product is to be done whether the extent and rate of absorption is not significantly different from the reference molecule when same dose is administered.

      Bioequivalence study should be carried out for the following types of formulations containing new active ingredient:

1. Oral solutions.
2. Oral and Non-oral formulations with immediate release and systemic action.
3. Modified release dosage form.
4. Fixed combinaiton product.
5. Parenteral formulations.
6. Gaseous formulation.
7. Locally applied product.

      The requirements of study approach may vary with the type of products or formulations.