Compliance with the new European bioequivalence guideline : development of a tool for assessment

Abstract

Many pharmaceutical companies invest in the development of non-originator medicinal products owing to the financial remuneration it offers. These medicinal products do not require the conduct of non-clinical and clinical studies if bioequivalence to the originator can be proven. This reduces ethical issues, costs and work to the pharmaceutical company and regulators. It also increases availability of the drug and reduces stock issues when the originator is unavailable thus aiding in public health and national health services. Bioequivalence studies submitted in support of a non-originator product's marketing authorisation application must be carried out in accordance with the current bioequivalence guideline unless adequately justified. Compliance to such a guideline is of paramount importance as justification for deviation from the guideline may lead to subjective interpretation thus affecting approvability of the product.