Acceptance of Foreign Comparator Products in Bioequivalence Studies

Regulatory Authorities participating in the IPRP Bioequivalence Working Group for Generics have differing requirements on the acceptability of bioequivalence studies conducted using foreign comparator product of oral dosage forms. The results of a survey conducted to compare the acceptance and requirements for foreign comparator products among the participating regulators and organisations were published in the Journal of Pharmacy and Pharmaceutical Sciences on 27 December 2018.

Survey of the Regulatory Requirements for the Acceptance of Foreign Comparator Products by Participating Regulators and Organizations of the International Generic Drug Regulators Programme. 

An abstract to this article was also published in the GaBI Journal on 30 April 2019.