From causality assessment to product labeling

Drug Information Journal

Volumn 31, Issue 3, 1997, Pages 849-856

  Stephens, Myles David Buckingham ^a  

^a NONE   (United Kingdom)

Author keywords

Causality assessment; Data sheet; Labeling; Signals

Indexed keywords

ARTICLE; DISEASE CLASSIFICATION; DRUG QUALITY; DRUG RESEARCH; EPIDEMIOLOGICAL DATA; PRACTICE GUIDELINE; PRIORITY JOURNAL; PUBLICATION; UNITED STATES;

EID: 0030876713     PISSN: 00928615     EISSN: None     Source Type: Journal    
DOI: 10.1177/009286159703100325     Document Type: Article

References (13)

1. Stephens MDB. The diagnosis of adverse medical events associated with drug treatment. Adv Drug React Ac Pois Res. 1987;1:1-35.
2. Venulet J. Role and place of causality assessment. Pharmacoepidem. 1992;1:225-234.
3. Bégaud B, Evreux J-C, Jouglard J, Lagier G. Unexpected or toxic drug reaction assessment (imputation). Therapie. 1985;40:11-18.
4. Venulet J, Ciuucci AG, Berneker G-C. Updating of a method for causality assessment of adverse drug reactions. Int J Clin Pharmacol. 1986;24:559-568
5. Karch FE, Lasagna L. Towards the operational identification of adverse drug reactions. Clin Pharmacol Ther. 1977;21:247-254.
6. 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. 1993;46:1323-1330.
7. Edwards JR, Lindquist M, Wiholm B-E, Napke E. Quality criteria for early signals of possible adverse drug reactions. Lancet. 1990;336:156-158.
8. Naranjo CA, Busto U, Sellers EM, Sandor P, Ruiz I, Roberts EA, Janecek E, Domecq C, Greenblatt DJ. A method for estimating the probability of adverse drug reactions. Clin Pharmacol Ther. 1981;30:2:239-245.
9. Sakurai Y, Kugai N, Kawana T, Fukita T, Fukumoto S. A comprehensive adverse events management system for the pharmaceutical industry : The Takeda Trac system. Drug Inf J. 1995;29:645-659.
10. Lane DA, Kramer MS, Hutchinson TA, Jones JK, Naranjo C. The causality assessment of adverse drug reactions using a Bayesian approach. Pharmaceut Med. 1987;2:265-283.
11. Levine MAH. A guide for assessing pharmacoepidemiologic studies. Pharmacotherapy. 1992;12(3): 232-237.
12. Glynn JR. A question of attribution. Lancet. 1993; 342:530-532.
13. Sackett DL, Haynes RB, Tugwell P. Deciding whether your treatment has done harm. In: Sackett DL, Haynes RB, Tugwell P. Eds. Clinical epidemiology: A basic science for clinical medicine. Boston, MA: Little, Brown; 1985;223-240.