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Guidance on the Framework for Implementation of Bio-Equivalence in Kenya

One of the key barriers to access to medicines is their affordability. Multisource Drug Products (MSDPs or generics medicines) policies can address this barrier and promote access to medicines of health importance in resource limited settings. Successful uptake of MSDPs depends, in part, on ensuring that they are interchangeable with originator's (comparator) product, also known as Reference Listed Drug (RLD). MSDPs need to conform to the same standards of quality, efficacy and safety as required of the RLD. Specifically, the MSDPs should be therapeutically equivalent and interchangeable with the RLD. Testing the bioequivalence (BE) between a product and a suitable RLD in a pharmacokinetic study with a limited number of subjects is one way of demonstrating therapeutic equivalence without having to perform a clinical trial involving many patients. In such a pharmacokinetic study any statement about the safety and efficacy of the test product will be a prediction based on measurement of systemic concentrations, assuming that essentially similar plasma concentrations of the drug will result in essentially similar concentrations at the site of action and therefore an essentially similar therapeutic outcome. The BE study thus provides indirect evidence of the efficacy and safety of MSDPs. Often this will be the only evidence that the product is safe and efficacious. It is therefore crucial that the BE study is performed in an appropriate manner1.The WHO Expert Committee on Specifications for Pharmaceutical Preparations, in 2006, provided recommendations for bioequivalence testing of essential medicines.

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