The updated edition replaces Guideline 42-7.3:2020 “Medicinal Products. Bioequivalence Studies”, approved by order No. 22 of the Ministry of Health of Ukraine dated 12.01.2017.
The changes made facilitate the justification of possible deviations in the proportionality of compositions of medicinal products containing several highly soluble active substances when demonstrating bioequivalence of several strengths (Addendum 7).
The information set out in the updated Guideline corresponds to the latest requirements of the EMA guidance EMA/618604/2008 Rev. «Questions & Answers: positions on specific questions addressed to the Pharmacokinetics Working Party», which supplement the guidance CPMP/QWP/EWP/1401/98 Rev.1/Corr** «Guideline on the Investigation of Bioequivalence».
The updated edition of Guideline ST-N MOZU 42-7.4:2022 “Medicinal Products. Bioequivalence Studies” was approved by order No. 2265 of the MoH of Ukraine of 15.12.2022
The guideline is available on the Center’s website at the link
