Regulations of Bioavailability and Bioequivalence Studies Article 10

While implementing bioavailability and bioequivalence studies, choice of subjects should comply with ethic codes of clinical studies. Normally the study subjects should be adult healthy volunteers, unless otherwise justified. Factors such as gender, age and ethnic groups should also be considered. The inclusion and exclusion criteria should be clearly stated in the protocol. Subjects should be screened by means of standard laboratory tests, medical history and physical examination. Depending on the characteristic profile of the drug product, special medical investigation may be carried out (i.e. ECG).The number of evaluable subjects in a bioequivalence study should not be less than 12. Prior to execution, studies should be approved by institutional review board (IRB) and written inform consent from subjects should be insured. Time intervals between studies of a subject shall conform to the standards of blood donors in order to protect the interest of the subject.