Signal detection and causality evaluation for pharmacovigilance

Journal of Korean Society for Clinical Pharmacology and Therapeutics

Volumn 13, Issue 2, 2005, Pages 121-133

  Lee, Seung Mi ^a,b   Hahn, Seokyung ^b   Park, Byung Joo ^a,b  

^a Seoul National University College of Medicine   (South Korea)

^b Seoul National University Hospital   (South Korea)

Author keywords

Causality; Pharmacoepidemiology; Pharmacovigilanc; Signal

Indexed keywords

EID: 76849088924     PISSN: 12255467     EISSN: None     Source Type: Journal    
DOI: 10.12793/jkscpt.2005.13.2.121     Document Type: Article

References (21)

1. Mann RD, Andrews EB, Editor. Pharmacovigilance. Chichester, John Wiley & Sons, Ltd, 2002
2. Strom BL, editor. Pharmacoepidemiology. 3rd ed. Chichester: John Wiley & Sons Ltd, 2000
3. World Health Organization. The importance of pharmacovigilance. 2002
4. International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use. ICH harmonized tripartite guideline: clinical safety data management: definitions and standards for expedited reporting - E2A. 1994
5. International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use. ICH harmonized tripartite guideline: Post-approval safety data management: definitions and standards for expedited reporting - E2D. 2003
6. International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use. ICH harmonized tripartite guideline: pharmacovigilance planning (PVP) - E2E. 2003
7. Hartzema AG, Porta M, Tilson HH, Editors. Pharmacoepidemiology: An Introduction. Third Edition. Harvey Whitney Books Company, 1998
8. Interpreting Epidemiologic Evidence : Strategies for Study Design and Analysis. David A. Savitz Oxford University Press; 2003
9. Clark JA, Klincewicz SL, Stang PE. Spontaneous Adverse Event Signaling Methods: Classification and Use with Health Care Treatment Products. Epidemiol Rev 2001; 23:191-2 10
10. World Health Organization. Guidelines for setting up and running a Pharmacovigilance Centre. 2002
11. Naranjo CA, Busto U, Sellers EM et al. A method for estimating the probability of adverse drug reactions. Clin Pharmacol Ther 1981;30:239-45
12. Moore N, Biour M, Paux G, Loupi E, Begaud B, Boismare F, Royer RJ. Adverse drug reaction monitoring: doing it the French way. Lancet 1985;9:1056-8
13. Danan G, Benichou C. Causality assessment of adverse reactions to drugs-I. A novel method based on the conclusions of international consensus meetings: application to drug-induced liver injuries. J Clin Epidemiol 199-3;46:1323-30
14. Evans SJW. Pharmacovigilance: a science or fielding emergencies. Statist Med 2000;19: 3199-3209
15. Korean J Med Assoc 2001;44:403-413
16. Korean J Clin Pharmacol Ther 1994;2:63-72
17. Korean source
18. Herbst AL, Ulfelder H, Poskanzer DC. Adenocarcinoma of the vagina. Association of maternal stilbestrol therapy with tumor appearance in young women. N Engl J Med 19-71;284:878 -881
19. Labarthe D, Adam E, Noller KL, et al. Design and preliminary observations of National Cooperative Diethylstilbestrol Adenosis (DESAD) Project. Obstet Gynecol 1978;51:453-8
20. Hatch EE, Palmer JR, Titus-Ernstoff L, et al. Cancer risk in women exposed to diethylstilbestrol in utero. JAMA 1998;280:630-4
21. Korean J Clin Pharmacol Ther 2002;10(2):129 -142