Safety and Tolerability of Seroguard Use

Summary

The performed study of safety and tolerability of Seroguard, solution (JSC Pharmasyntez, Russia) in patients, undergoing planned laparoscopic cholecystectomy, demonstrated that patients from the both groups had the similar safety profile

Timeline

Start

2015-05-19

Primary completion

2015-10-04

Completion

2015-10-04

Publications

• Background The Federal Law dated 12.04.2010 №61-ФЗ "On drug circulation" (as amended Federal Laws dated 27.07.2010 N 192-ФЗ, dated 11.10.2010 N 271-ФЗ, dated 29.11.2010 N 313-ФЗ, dated 06.12.2011 N 409-ФЗ, dated 25.06.2012 N 93-ФЗ, dated 25.12.2012 N 262-ФЗ, dated 02.07.2013 N 185-ФЗ, dated 25.11.2013 N 317-ФЗ, dated 12.03.2014 N 33-ФЗ, dated 22.10.2014 N 313-ФЗ)
• Background The Order of the Ministry of Health, the Russian Federation, No 266 dated 19.06.2003.
• Background GOST R 52379-2005 "National standard of the Russian Federation "Good Clinical Practice" (approved by the Order of the Federal Agency for Technical Regulation and Metrology dated 27th of September, 2005 No 232-ст).
• Background Declaration of Helsinki, World Medical Association (as revised, approved at 64th General Assembly, Fortaleza (Brazil, 2013))
• Background Guideline on inspection of medicinal drugs. Volume I. Grif and K, 2013. - 328 p.
• Background Bonferroni, C. E. (1936). Teoria statistica delle classi e calcolo delle probabilità, Pubblicazioni del R Istituto Superiore di Scienze Economiche e Commerciali di Firenze.
• Background Stata Statistical Software: Release 13. College Station T:SL, 2.

Drugs

Indications

No indication recorded.