английский => русский Медицина Медицина: Фармацевтика Clinical Study Report

This study was carried out in accordance with the protocol and was compliant with all the requirements regarding the obligations of investigators and all other pertinent requirements of the Schedule Y (amended version, 2013) of CDSCO (Central Drugs Standard Control Organization), Ministry of health and family welfare, Government of India, Ethical guidelines for biomedical research on human participants, ICMR [Indian Council of Medical Research (2006)], ICH (International Conference on Harmonization) E6 (R1) ‘Guideline for Good Clinical Practice’ 1996, CPMP guidance on the investigation of bioavailability and bioequivalence (CPMP/QWP/EWP/1401/98 Rev. 1, London, 20 January 2010) and Declaration of Helsinki (Brazil, October 2013).