Applicants and Contract Research Organizations (CROs) performing bioequivalence studies are reminded that all studies with human subjects must be conducted in compliance with Good Clinical Practices (GCP), which requires that the rights, safety, and well-being of trial subjects be given top priority in every trial conducted. The eligibility and prospective health of trial subjects is assessed through numerous pre-study, in-study, and post-study tests, including the assessment of serum biochemistry and haematology parameters. The measured values for these parameters are compared to a pre-defined set of site normal values, which have been established as a “normal range” for each parameter at the study site in question.
The enrolment of a subject with measured values for the health verification parameters that fall outside the pre-defined site normal values should not occur, except on a rare, exceptional basis. On the rare occasion where a subject is enrolled in a study despite having a measurement outside the site normal range, the study physician should have a clearly documented and medically rigorous justification for making that exception.