Bioequivalence and Bioavailability Forum

Dear All

As per EU guideline following is the criteria for parallel design study.

“In parallel design studies, the treatment groups should be comparable in all known variables that may affect the pharmacokinetics of the active substance (e.g. age, body weight, sex, ethnic origin, smoking status, extensive/poor metabolic status). This is an essential pre-requisite to give validity to the results from such studies.”

We are planning to conduct a parallel study for EU submission. Please advice how can we minimize these variables and make uniform distribution of volunteers between two parallel group for such bioequivalence study to reduce the variability in result because of above mentioned active substances.

thanks