HARMONIZATION IN PHARMACOVIGILANCE

[1] 21 GFR 314.80 Federal Register, 50, 30, (1985)

[2] International reporting of adverse drug reactions, (1990)

[3] Delamothe T., Reporting adverse drug reactions, British Medical Journal, 304, (1992)

[4] CPMP Working Party. Notes for guidance 111/3976/88-EN, (1988)

[5] Notice to applicants III73567/92, pp. 125-126, (1993)

[6] Clinical safety data management: definitions and standards for expedited reporting ICH-2 EWG E2, (1994)

[7] Karch F.E., Lasagna L., Adverse drug reactions, Journal of the American Medical Association, 234, pp. 1236-1239, (1975)

[8] Leon D.A., Failed or misleading adjustment for confounding, Lancet, 342, pp. 479-481, (1993)

[9] Stephens M.D.B., Detection of new adverse drug reactions, (1992)

[10] Waller P.C., Wood S.M., Langman M.J.S., Breckenridge A.M., Rawlins M.D., Review of company post-marketing studies, British Medical Journal, 304, pp. 1470-1472, (1992)

[1] 21 GFR 314.80 Federal Register, 50, 30, (1985)

[2] International reporting of adverse drug reactions, (1990)

[3] Delamothe T., Reporting adverse drug reactions, British Medical Journal, 304, (1992)

[4] CPMP Working Party. Notes for guidance 111/3976/88-EN, (1988)

[5] Notice to applicants III73567/92, pp. 125-126, (1993)

[6] Clinical safety data management: definitions and standards for expedited reporting ICH-2 EWG E2, (1994)

[7] Karch F.E., Lasagna L., Adverse drug reactions, Journal of the American Medical Association, 234, pp. 1236-1239, (1975)

[8] Leon D.A., Failed or misleading adjustment for confounding, Lancet, 342, pp. 479-481, (1993)

[9] Stephens M.D.B., Detection of new adverse drug reactions, (1992)

[10] Waller P.C., Wood S.M., Langman M.J.S., Breckenridge A.M., Rawlins M.D., Review of company post-marketing studies, British Medical Journal, 304, pp. 1470-1472, (1992)