The complex issue of testing for bioequivalence was covered in a recent article by Phil Taylor, In-pharma. It is recognized that the FDA has the very complex job of determining bioequivalence of generics to innovator products. Physicians and patients rely on FDA regulations for safety and efficacy of all drugs approved for use, including generics. To bring the FDA and physicians together to work in concert, the article discusses the benefit that could manifest when the FDA can share and disclose data and information used in justification for bioequivalence with physicians who make drug decisions on behalf of their unique patient needs. The physician, when armed with all of the information the FDA has about a drug, can be the best advocate for the individual patient when recommending drug therapy. The physician / patient relationship conducts the final “clinical trial” of whether a drug, generic or not, is effective & safe for the patient.
For more information on this interesting topic, please view Taylor’s article here.