A new edition of the Guideline on Bioequivalence Studies has been approved
By order No. 2014 of the Ministry of Health of Ukraine of 02.11.2018, the guideline “Medicinal Products. Bioequivalence Studies”, approved by order No. 22 of the Ministry of Health of Ukraine of 12.01.2017, is restated in a new edition.
The updated edition of the Guideline “Medicinal Products. Bioequivalence Studies” is introduced to replace guideline 42-7.1:2016 “Medicinal Products. Bioequivalence Studies.”
In the new edition of the Guideline, in order to improve and justify approaches to conducting studies, taking into account the properties and specifics of use of various dosage forms, the following new additions have been made:
- Requirements for a bioequivalence study of a generic medicinal product if the SmPC of the reference medicinal product allows taking a crushed / disintegrated tablet (mixed or not mixed with food);
- Requirements for a bioequivalence study of a medicinal product in the dosage form
- oral solution (or suspension) in single-dose sachets, if the test medicinal product is to be taken with or without water (or there is no information on taking water),
- powder or granules for oral use in single-dose sachets, if the investigational medicinal product is to be taken with or without water;
- Explanation to the section “Solutions for oral use” of Appendix II to this guideline regarding the conditions for waiving in vivo studies.
The information set out in the new additions complies with the latest requirements of the guideline EMA/618604/2008 Rev. “Questions & Answers: positions on specific questions addressed to the Pharmacokinetics Working Party” (Guideline on bioequivalence studies, PKWP), Questions and answers: position on specific questions addressed to the PKWP), which supplements the guideline CPMP/QWP/EWP/1401/98 Rev.1/Corr** “Guideline on the Investigation of Bioequivalence”.
Note. The updated version of the guideline is posted on the website of the State Expert Center of the Ministry of Health of Ukraine in the “Guidelines” section and is available at the link “Bioequivalence Studies”
