Planning issues for darunavir (DRV) bioequivalence studies are considered. DRV is an antiviral (HIV) agent classified as an HIV protease inhibitor. Bioequivalence test results must be submitted for registration of generic drugs in the RF according to Federal Law 61-FZ. Bioequivalence study protocols and reports for DRV preparations that were submitted for review to the SCEEMP were analyzed. Differences in study designs including administration after fasting or meals, with or without a low dose of ritonavir, numbers of volunteers included in the study, and intra-subject variability were found. The internet was also searched for data on DRV variability. Recommendations for planning bioequivalence studies of DRV preparations were formulated based on the analysis.
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References
J. Robertson and J. Feinberg, Expert Opin. Pharmacother., 13(9), 1363 – 1375 (2012).
F. Barré-Sinoussi, A. L. Ross, and J. F. Delfraissy, Nat. Rev. Microbiol., 11(12), 877 – 883 (2013).
E. D. Deeks, Drugs, 74(1), 99 – 125 (2014).
Instructions for Medical Use of Prezista ® , State Drug Registry (2018).
http://itpcru.org/2018/04/18/analiz-zakupok-arv-preparatov-v-rf-v-2017-godu/ (2018)
Russian Federation Federal Law No. 61-FZ dated Apr. 12, 2010 “On circulation of medicines” [in Russian], Moscow (2010).
A. N. Mironov (ed.), Handbook for Drug Review [in Russian], Vol. 1, Grif i K, Moscow (2013), pp. 174 – 215.
Rules for Conducting Bioequivalence Studies of Drugs in the Eurasian Economic Union, approved by Decision No. 85 of the Eurasian Economic Commission Committee dated Nov. 3, 2016, Moscow (2016).
Investigation of Bioequivalence (CPMP / EWP / QWP / 1401 / 98 Rev. 1), European Medicines Agency, London (2013).
Assessment Report for Prezista (EMEA / CHMP / 259742 / 2009), European Medicines Agency, London (2009).
A. A. Mathias, S. West, J. Hui, and B. P. Kearney, Clin. Pharmacol. Ther., 85(1), 64 – 70 (2009).
S. Katzenmaier, C. Markert, K. D. Riedel, et al., Clin. Pharmacol. Ther., 90(5), 666 – 673 (2011).
C. Eichbaum, M. Cortese, A. Blank, et al., Eur. J. Clin. Pharmacol., 69(10), 1795 – 1800 (2013).
D. J. Greenblatt, J. Clin. Pharmacol., 56(2), 152 – 156 (2016).
https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM204389.pdf
I. B. Bondareva, V. B. Gerasimov, A. P. Drozhzhin, et al., Klin. Farmakokinet., No. 1, 2 – 14 (2005).
Guidance for Industry. Bioavailability and Bioequivalence Studies Submitted in NDAs and INDs: General Considerations, US Dept. Health Human Services, Food and Drug Administration, Rockville, MD (2014).
D. P. Romodanovskii, T. V. Eremenkova, M. A. Dranitsyna, et al., Vedom. Nauchn. Tsentra Ekspert. Sredstv Med. Primeneniya, No. 4, 5 – 10 (2015).
B. M. Davit, D. P. Conner, B. Fabian-Fritsch, et al., AAPS J., 10(1), 148 – 156 (2008).
S. H. Haidar, B. Davit, M. L. Chen, et al., Pharm. Res., 25(1), 237 – 241 (2008).
T. N. Kakuda, L. Leopold, M. Timmers, et al., Int. J. Clin. Pharmacol. Ther., 52(9), 805 – 816 (2014).
https://extranet.who.int/prequal/sites/default/files/HA627part6v02.pdf
A. Gupta, P. Singhal, P. S. Shrivastav, and M. Sanyal, J. Chromatogr. B: Anal. Technol. Biomed. Life Sci., 879(24), 2443 – 2453 (2011).
http://www.mhra.gov.uk/home/groups/par/documents/websiteresources/con814242.pdf
T. N. Kakuda, T. Van De Casteele, R. Petrovic, et al., Antiviral Ther., 19(6), 597 – 606 (2014).
https://extranet.who.int/prequal/sites/default/files/documents/14%20BE%20darunavirOct20150.pdf
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Translated from Khimiko-Farmatsevticheskii Zhurnal, Vol. 52, No. 9, pp. 22 – 26, September, 2018.
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Uvarova, N.E., Eremenko, N.N., Ramenskaya, G.V. et al. Planning and Assessment of Bioequivalence Studies of Darunavir Preparations. Pharm Chem J 52, 771–775 (2018). https://doi.org/10.1007/s11094-018-1897-z
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DOI: https://doi.org/10.1007/s11094-018-1897-z