publication . Article . 2021

Planning Bioequivalence Studies in the Context of the COVID-19 Pandemic

D. P. Romodanovsky; A. L. Khokhlov; D. V. Goryachev;
Open Access Russian
  • Published: 01 Mar 2021 Journal: Ведомости Научного центра экспертизы средств медицинского применения, volume 11, issue 1, pages 6-15 (issn: 1991-2919, eissn: 2619-1172, Copyright policy)
  • Publisher: OOO “Vashe Tsifrovoe Izdatelstvo”
Abstract
The coronavirus (COVID-19) pandemic, which began in 2020, has affected all spheres of life, including clinical trial processes. Health authorities around the world issued recommendations aimed at minimising the risks of virus spreading and ensuring the safety of study participants. One of the types of clinical trials is bioequivalence studies of generic medicines. The aim of the study was to analyse current foreign approaches to planning and conduct of bioequivalence studies of medicines in the context of the COVID-19 pandemic, and to develop recommendations for planning of studies conducted in the Eurasian Economic Union and evaluation of their results. The pap...
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free text keywords: bioequivalence, bioequivalence studies, generic medicines, pandemic, coronavirus, covid-19, Medicine (General), R5-920
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