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Volumn 19, Issue 4, 1997, Pages 186-190

Good practice in the postmarketing surveillance of medicines

Author keywords

Adverse drug reactions; Good practice; Medical ethics; Pharmacovigilance; Postmarketing surveillance

Indexed keywords

ARTICLE; DRUG MONITORING; DRUG SAFETY; DRUG SURVEILLANCE PROGRAM; GOOD CLINICAL PRACTICE; LAW; MEDICAL ETHICS; PRACTICE GUIDELINE; PUBLIC HEALTH;

EID: 0030879777     PISSN: 09281231     EISSN: None     Source Type: Journal    
DOI: 10.1023/A:1008610722972     Document Type: Article
Times cited : (16)

References (48)
  • 1
    • 0004075491 scopus 로고
    • Guidelines for good clinical practice (GCP) for trials on pharmaceutical products
    • World Health Organization Geneva, Switzerland
    • Guidelines for good clinical practice (GCP) for trials on pharmaceutical products. WHO Technical Report Series, No. 850, 1995. World Health Organization Geneva, Switzerland.
    • (1995) WHO Technical Report Series , Issue.850
  • 11
    • 0015275791 scopus 로고
    • International Drug Monitoring: The Role of National Centres
    • Geneva
    • International Drug Monitoring: The Role of National Centres. World Health Organization Technical Report Series, No. 498, Geneva, 1972.
    • (1972) World Health Organization Technical Report Series , Issue.498
  • 13
    • 0003713955 scopus 로고
    • Carnforth: Parthenon Publishing Group
    • Mann RD, ed. Adverse Drug Reactions. Carnforth: Parthenon Publishing Group, 1987.
    • (1987) Adverse Drug Reactions
    • Mann, R.D.1
  • 14
    • 8544229289 scopus 로고
    • Voluntary systems of adverse reaction reporting
    • Griffin JP, D'Arcy PF, Harron DWG, eds. Antrim: Greystone Books
    • Griffin JP, Weber JCP. Voluntary systems of adverse reaction reporting. In: Griffin JP, D'Arcy PF, Harron DWG, eds. Medicines: regulation, research and risk. Antrim: Greystone Books, 1989.
    • (1989) Medicines: Regulation, Research and Risk
    • Griffin, J.P.1    Weber, J.C.P.2
  • 15
    • 0023925775 scopus 로고
    • Spontaneous reporting of adverse drug reactions
    • Rawlins MD. Spontaneous reporting of adverse drug reactions. Brit J Clin Pharmacol 1988;26:1-11.
    • (1988) Brit J Clin Pharmacol , vol.26 , pp. 1-11
    • Rawlins, M.D.1
  • 16
    • 0012046941 scopus 로고
    • Spontaneous reporting systems outside the United States
    • Strom BL, ed. New York: Churchville Livingstone
    • Wiholm BE, Olsson S. Spontaneous reporting systems outside the United States. In: Strom BL, ed. Pharmacoepidemiology. New York: Churchville Livingstone, 1989:119.
    • (1989) Pharmacoepidemiology , pp. 119
    • Wiholm, B.E.1    Olsson, S.2
  • 17
    • 8544258926 scopus 로고
    • Spontaneous monitoring of adverse reactions to drugs, procedures and experiences in the Netherlands
    • Strom BL, Velo G, eds. New York: Plenum Press
    • Meyboom RHB. Spontaneous monitoring of adverse reactions to drugs, procedures and experiences in the Netherlands. In: Strom BL, Velo G, eds. Drug epidemiology and post-marketing surveillance. New York: Plenum Press, 1992:21.
    • (1992) Drug Epidemiology and Post-marketing Surveillance , pp. 21
    • Meyboom, R.H.B.1
  • 18
    • 84973795022 scopus 로고
    • Panel on management of ADR reports in selected national centres
    • McEwen J, Vrhovac B. Panel on management of ADR reports in selected national centres. Drug Information Journal 1985;19:329-44.
    • (1985) Drug Information Journal , vol.19 , pp. 329-344
    • McEwen, J.1    Vrhovac, B.2
  • 19
    • 84902319790 scopus 로고
    • Causality classification at pharmacovigilance centres in the European Community
    • Meyboom RHB, Royer RJ. Causality classification at pharmacovigilance centres in the European Community. Pharmacoepidemiology and Drug Safety 1992;1:87-97.
    • (1992) Pharmacoepidemiology and Drug Safety , vol.1 , pp. 87-97
    • Meyboom, R.H.B.1    Royer, R.J.2
  • 21
    • 8544261252 scopus 로고    scopus 로고
    • Council Regulation (EEC) No 2309/93, Articles 19 - 22
    • Council Regulation (EEC) No 2309/93, Articles 19 - 22.
  • 22
    • 8544254096 scopus 로고    scopus 로고
    • Council Directive 75/319/EEC as amended, Chapter Va, Articles 29b to 29d
    • Council Directive 75/319/EEC as amended, Chapter Va, Articles 29b to 29d.
  • 24
    • 8544227051 scopus 로고
    • Drug Safety Research Unit, Bursledon Hall, Southampton, SO3 8BA
    • Inman WHW. PEM News, No. 5, 1988. Drug Safety Research Unit, Bursledon Hall, Southampton, SO3 8BA.
    • (1988) PEM News , Issue.5
    • Inman, W.H.W.1
  • 25
    • 0029785280 scopus 로고    scopus 로고
    • Speaking about pharmacovigilance
    • McNamee D. Speaking about pharmacovigilance. Lancet 1996;348:908.
    • (1996) Lancet , vol.348 , pp. 908
    • McNamee, D.1
  • 26
    • 0027988758 scopus 로고
    • Informatie en toestemming in de gezondheidszorg; recente ontwikkelingen
    • Roscam Abbing HDC. Informatie en toestemming in de gezondheidszorg; recente ontwikkelingen. Ned Tijdschr Geneeskd 1994;138:2561-4.
    • (1994) Ned Tijdschr Geneeskd , vol.138 , pp. 2561-2564
    • Roscam Abbing, H.D.C.1
  • 27
    • 0002126118 scopus 로고
    • Databases, privacy, and confidentiality - The effect of proposed new legislation on pharmacoepidemiology and drug safety monitoring
    • Aronson JK, Van Boxtel CJ, eds. Amsterdam: Elsevier, xxi-xxxv
    • Mann RD. Databases, privacy, and confidentiality - the effect of proposed new legislation on pharmacoepidemiology and drug safety monitoring. In: Aronson JK, Van Boxtel CJ, eds. Side Effects of Drugs Annual 18. Amsterdam: Elsevier, 1995 (xxi-xxxv).
    • (1995) Side Effects of Drugs Annual 18
    • Mann, R.D.1
  • 28
    • 0029854245 scopus 로고    scopus 로고
    • The use of confidential medical data and postmarketing surveillance: A survey of the opinion of patients
    • De Wit MEC, Porsius AJ, Stricker BHCh. The use of confidential medical data and postmarketing surveillance: a survey of the opinion of patients. Pharmacoepidemiology and Drug Safety 1996;5:321-4.
    • (1996) Pharmacoepidemiology and Drug Safety , vol.5 , pp. 321-324
    • De Wit, M.E.Ch.1    Porsius, A.J.2    Stricker, B.3
  • 29
    • 0028049067 scopus 로고
    • Harmonisation in pharmacovigilance
    • Edwards IR, Biriell C. Harmonisation in pharmacovigilance. Drug Safety 1994;10:93-102.
    • (1994) Drug Safety , vol.10 , pp. 93-102
    • Edwards, I.R.1    Biriell, C.2
  • 30
    • 0025330184 scopus 로고
    • Quality criteria for early signals of possible adverse drug reactions
    • Edwards R, Lindquist M, Wiholm BE, Napke E. Quality criteria for early signals of possible adverse drug reactions. Lancet 1990;336:156-8.
    • (1990) Lancet , vol.336 , pp. 156-158
    • Edwards, R.1    Lindquist, M.2    Wiholm, B.E.3    Napke, E.4
  • 32
    • 0004193210 scopus 로고
    • December Agence du Médicament, 143-147 boulevard Anatole France, Saint-Denis
    • Bonnes Pratiques de Pharmacovigilance. December 1994, Agence du Médicament, 143-147 boulevard Anatole France, Saint-Denis.
    • (1994) Bonnes Pratiques de Pharmacovigilance
  • 36
    • 85025270206 scopus 로고
    • Basic requirements for the use of terms for reporting adverse drug reactions
    • Council for International Organizations of Medical Sciences (CIOMS)
    • Basic requirements for the use of terms for reporting adverse drug reactions. Council for International Organizations of Medical Sciences (CIOMS). Pharmacoepidemiology and Drug Safety 1992;1:39-45.
    • (1992) Pharmacoepidemiology and Drug Safety , vol.1 , pp. 39-45
  • 37
    • 8544268787 scopus 로고
    • Committee for Proprietary Medicinal Products. Commission of the European Communities. III/3174/93-EN, Draft no. 4
    • Guideline on adverse reactions reporting by marketing authorisation holders. Committee for Proprietary Medicinal Products. Commission of the European Communities. III/3174/93-EN, Draft no. 4, 1993.
    • (1993) Guideline on Adverse Reactions Reporting by Marketing Authorisation Holders
  • 38
  • 41
    • 0028572438 scopus 로고
    • The Medical Dictionary for Drug Regulatory Affairs (MEDDRA) Project
    • Wood KL. The Medical Dictionary for Drug Regulatory Affairs (MEDDRA) Project. Pharmacoepidemiology and Drug Safety 1994;3:7-13.
    • (1994) Pharmacoepidemiology and Drug Safety , vol.3 , pp. 7-13
    • Wood, K.L.1
  • 42
    • 8544273372 scopus 로고
    • Towards and adverse drug reactions dictionary. Should existing terminologies be harmonized?
    • Bénichou C. Towards and adverse drug reactions dictionary. Should existing terminologies be harmonized? Pharmacoepidemiology and Drug Safety 1993;2:185-8.
    • (1993) Pharmacoepidemiology and Drug Safety , vol.2 , pp. 185-188
    • Bénichou, C.1
  • 47
    • 10544229343 scopus 로고    scopus 로고
    • Guidelines for Good Epidemiology Practices for Drug, Device and Vaccine Research in the United States
    • ISPE Notice
    • ISPE Notice. Guidelines for Good Epidemiology Practices for Drug, Device and Vaccine Research in the United States. Pharmacoepidemiology and Drug Safety 1996;5:333-8.
    • (1996) Pharmacoepidemiology and Drug Safety , vol.5 , pp. 333-338


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.