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Regulatory Requirements of the European Medicines Agency for Evaluation of Bioequivalence of Modified-release Medicinal Products
Ведомости Научного центра экспертизы средств медицинского применения
There are no specific requirements and recommendations in the Russian Federation for evaluation of bioequivalence of modified-release medicinal products. Until recently, modified-release products were regulated in a similar manner as immediate-release products, which is unacceptable considering the active ingredient release profile and its pharmacokinetics. The modified release characteristics require a more complex approach to the assessment of equivalence of generic medicines as compared withdoi:10.30895/1991-2919-2019-9-1-28-33 fatcat:eq7d76ea7vcx3canqpw6kgot7i