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EEC Board adopted guidelines for conducting bioequivalence studies of medicines in high-tech dosage forms

EEC Board adopted guidelines for conducting bioequivalence studies of medicines in high-tech dosage forms

9/16/2020

The Eurasian Economic Commission’s Board has adopted two guidelines regulating the formulation development and confirmation of equivalent efficiency and safety of micellar solutions and nanomedicines.

The guidelines have set the standard for research efforts on quality indicators of copied medicines in these dosage forms in relation to original (reference) pharmaceuticals, types of research with direct human involvement and ways of modeling in laboratory conditions and provided instructions for drafting specifications for these groups of dosage forms. Besides traditional equivalence indicators, the manufacturer should prove, for such dosage forms, their affinity to elimination half-life from the human body and study distribution to target tissues for nanomedicines in order to prove the absence of pharmaceutical-specific toxicity to these tissues.

The guidelines are unprecedented in the national legislation of the Eurasian Economic Union States. Their use will help prevent releasing understudied dosage forms with adverse effects into circulation.

The approaches proposed in new documents to establishing equal efficiency and safety of these dosage forms will also enable reducing manufacturers' cost on performing full-scale clinical studies, replacing them with studies on small groups of volunteers or modeling such studies.