როგორ უნდა ციტირება
ჭუმბურიძე თ., იმნაძე ნ., & კიკვაძე ზ. (2019). წამლის გვერდითი ეფექტების მონიტორინგი (ფარმაკოვიჟილანსი) - მოსახლეობის ეფექტური და უსაფრთხო ფარმაკოთერაპიის მნიშვნელოვანი იარაღი. თბილისის სახელმწიფო სამედიცინო უნივერსიტეტის სამეცნიერო შრომათა კრებული, 51, 124–127. https://doi.org/10.52340/csw.2017.51.124-127
ანოტაცია
თანამედროვე სამკურნალო საშუალებები ეფექტურად ებრძვიან სხვადასხვა დაავადებებს. თუმცა, მათი სარგებელის მიუხედავად, იზრდება პრეპარატების გვერდითი ეფექტებით გამოწვეული დაავადებების, ინვალიდობის და ზოგჯერ ლეტალური შემთხვევების რაოდენობა. ზოგიერთ ქვეყანაში პრეპარატის გვერდითი ეფექტები შედის სიკვდილიანობის გამომწვევი მიზეზების პირველ ათეულში [1]. ყოველ კონკრეტულ შემთხვევაში ეფექტური და უსაფრთხო პრეპარატის შერჩევა მნიშვნელოვნად არის დამოკიდებული მკურნალი ექიმის უნარსა და ცოდნაზე სწორად შეაფასოს სიტუაცია.
წყაროები
1. World Health Organization. The Importance of Pharmacovigilance: Safety Monitoring of Medicinal Products. Geneva: WHO, http://apps.who.int/medicinedocs/pdf/ s4893e/ s4893e. 2002.
2. European Commission. Assessment of the European Community System of Pharmacovigilance: Final Report e Final version, January 25. Submitted by Fraunhofer Institute Systems and Innovation Research, Karlsruhe, Germany, to the European Commission Enterprise and Industry Directorate- General, Unit F2, Pharmaceuticals, http://ec.europa.eu/enterprise/pharmaceuticals/pharmacovigilance/docs/acs_consultation_final.pdf; 2006.
3. Nwokike J. Technical Assistance for the Establishment of a Pharmacovigilance and Medicine Safety System in Rwanda. Submitted to the US Agency for International Development by the Strengthening Pharmaceutical Systems (SPS) Program. Arlington, VA: Management Sciences for Health; 2009.
4. Kranish, M. New use is found for thalidomide: Fighting cancer. Boston Globe Online, October 20, 2002
5. 40 years after the thalidomide holocaust. Available: www.thalidomide.org/FfdN/Grun en/Grunthl.html
6. Castilla EE et al. Thalidomide, a current teratogen in South America. Teratology1996, 54: 273.
7. US Food and Drug Administration. 21 CFR Parts 312 and 320, Final Rule: Investigational New Drug Safety Reporting Requirements for Human Drug and Biological Products and Safety Reporting Requirements for Bioavailability and Bioequivalence Studies in Humans, http://www.fda.gov/ Drugs/ Development Approval Process/ How Drugs are Developed andApproved/ApprovalApplications/ Investigational NewDrug INDApplication/ucm226358.htm
8. Gaukler SM1, Ruff JS2, Galland T2, Underwood TK2, Kandaris KA2, Liu NM2, Morrison LC2, Veranth JM3, Potts WK2. Quantification of cerivastatin toxicity sup ports organismal performance assays as an effective tool during pharmaceutical safety assessment. Evol Appl. 2016 Apr 15;9(5):685-96. 2016.
9. SAFETY MONITORING of MEDICINAL PRODUCTS. World Health Organization 2012
10. Marie Lindquist, Malin Stahl, Andrew Bate I., Ralph Edwards, Ronald H.B. Meyboom. A Retrospective Evaluation of a Data Mining Approach to Aid Finding New Adverse Drug Reaction Signals in the WHO International Database. Drug Safety, December 2000, Volume 23, Issue 6, pp 533–542.
2. European Commission. Assessment of the European Community System of Pharmacovigilance: Final Report e Final version, January 25. Submitted by Fraunhofer Institute Systems and Innovation Research, Karlsruhe, Germany, to the European Commission Enterprise and Industry Directorate- General, Unit F2, Pharmaceuticals, http://ec.europa.eu/enterprise/pharmaceuticals/pharmacovigilance/docs/acs_consultation_final.pdf; 2006.
3. Nwokike J. Technical Assistance for the Establishment of a Pharmacovigilance and Medicine Safety System in Rwanda. Submitted to the US Agency for International Development by the Strengthening Pharmaceutical Systems (SPS) Program. Arlington, VA: Management Sciences for Health; 2009.
4. Kranish, M. New use is found for thalidomide: Fighting cancer. Boston Globe Online, October 20, 2002
5. 40 years after the thalidomide holocaust. Available: www.thalidomide.org/FfdN/Grun en/Grunthl.html
6. Castilla EE et al. Thalidomide, a current teratogen in South America. Teratology1996, 54: 273.
7. US Food and Drug Administration. 21 CFR Parts 312 and 320, Final Rule: Investigational New Drug Safety Reporting Requirements for Human Drug and Biological Products and Safety Reporting Requirements for Bioavailability and Bioequivalence Studies in Humans, http://www.fda.gov/ Drugs/ Development Approval Process/ How Drugs are Developed andApproved/ApprovalApplications/ Investigational NewDrug INDApplication/ucm226358.htm
8. Gaukler SM1, Ruff JS2, Galland T2, Underwood TK2, Kandaris KA2, Liu NM2, Morrison LC2, Veranth JM3, Potts WK2. Quantification of cerivastatin toxicity sup ports organismal performance assays as an effective tool during pharmaceutical safety assessment. Evol Appl. 2016 Apr 15;9(5):685-96. 2016.
9. SAFETY MONITORING of MEDICINAL PRODUCTS. World Health Organization 2012
10. Marie Lindquist, Malin Stahl, Andrew Bate I., Ralph Edwards, Ronald H.B. Meyboom. A Retrospective Evaluation of a Data Mining Approach to Aid Finding New Adverse Drug Reaction Signals in the WHO International Database. Drug Safety, December 2000, Volume 23, Issue 6, pp 533–542.
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