Some observations on pharmacoepidemiology in Europe

Netherlands Journal of Medicine

Volumn 51, Issue 6, 1997, Pages 205-212

  Van Boxtel, C J ^a   Wang, G ^a,b  

^a ACADEMIC MEDICAL CENTER   (Netherlands)

^b WUHAN UNIVERSITY   (China)

Author keywords

European Union; Good post marketing surveillance practice; Pharmacoepidemiology; Regulations

Indexed keywords

ARTICLE; DRUG SURVEILLANCE PROGRAM; DRUG UTILIZATION; EUROPEAN UNION; NONHUMAN; PHARMACOEPIDEMIOLOGY; PRACTICE GUIDELINE; WORLD HEALTH ORGANIZATION;

DATABASES; DRUG INDUSTRY; EUROPEAN UNION; FORECASTING; GUIDELINES; HUMANS; PHARMACOEPIDEMIOLOGY; PRODUCT SURVEILLANCE, POSTMARKETING;

EID: 0031472950     PISSN: 03002977     EISSN: None     Source Type: Journal    
DOI: 10.1016/S0300-2977(97)00054-5     Document Type: Article

References (25)

1. Spitzer WO. The bridge science of pharmacoepidemiology. Eur J Clin Res 1994;61:52-62.
2. Kusunoki T. Post-marketing surveillance and pharmacoepidemiology in Japan. Eur J Clin Res 1994;61:74-78.
3. Phillips-Howard P-A. Regulation of drug use and post-registration surveillance. Trans R Soc Trop Med Hyg 1994;88(suppl):59-62.
4. ten Ham M. WHO's role in international ADR monitoring. Post Market Surveil 1992;5:223-230.
5. Edwards IR. International drug monitoring. In: Aronson JK, van Boxtel CJ, editors. Side Effects of Drugs Annual 19. Amsterdam: Elsevier, 1996;450-455.
6. Lindquist M, Sanderson J, Claesson C, Imbs JL, Rohan A, Edwards IR. New pharmacovigilance information on an old drug. An international study of spontaneous reports on digoxin. Drug Invest 1994;8:73-80.
7. Castle WM. The EEC and CIOMS. Post Market Surveil 1992;5:213-216.
8. Royer R. The pharmacovigilance in the European Community: today and post 1992. In: Shimizu N, Tanaka Y, Jones J, Taylor D, editors. Improving Drug Safety. The Assessment, Management and Communication of the Therapeutic Benefits and Risks of Pharmaceutical Products. Japan: Pharama International, 1990;121-124.
9. Royer R. Pharmacovigilance in the EC, basis and prospective. Post Market Surveil 1992;5:309-310.
10. Wood KL. The medical dictionary for drug regulatory affairs (MEDDRA) project. Pharmacoepidemiol Drug Saf 1994;3:7-13.
11. Begaud B, Chaslerie A, Haramburu F. Organization and results of pharmacovigilance in France. Rev Epidemiol Santé Publ 1994;42:416-423.
12. Begaud B, Moride Y, Haramburu F. Quality improvement and statistical calculations made on spontaneous reports. Drug Inf J 1994;28:1187-1195.
13. Begaud B, Moride Y, Tubert-Bitter P, Chaslerie A, Haramburu F. False-positives in spontaneous reporting: Should we worry about them?. Br J Clin Pharmacol 1994;8:401-404.
14. Miremont G, Haramburu F, Begaud B, Pere JC, Dangoumau J. Adverse drug reactions: physicians' opinions versus a causality assessment method. Eur J Clin Pharmacol 1994;6:285-289.
15. Hallas J, Nissen A. Individualized drug utilization statistics. Analysing a population's drug use from the perspective of individual users. Eur J Clin Pharmacol 1994;47:367-372.
16. Sorensen HT, Larsen BO. A population-based Danish data resource with possible high validity in pharmacoepidemiological research. J Med Syst 1994;18:33-38.
17. Mann RD. Databases and drug epidemiology - The situation in the UK, Eur J Clin Res 1994;6:92-104.
18. Kubota K, Inman WH. Terminology in prescription-event monitoring. Eur J Clin Pharmacol 1994;46:497-500.
19. Mann RD. The VAMP system and the detection of risk, some examples. Pharmacoepidemiol Drug Saf 1994;3:313-319.
20. Herings RMC. PHARMO: a record linkage system for post marketing surveillance of prescription drugs in the Netherlands (Thesis). Utrecht University, 1993.
21. Wade OL. Plenary Lecture. In: Sjöqvist F, Agenäs I, editors. Drug Utilization Studies: Implications for Medical Practice. Proceedings from ANIS Symposium, Sånga-Säby, Sweden, 1982. Acta Med Scand 1983;683(suppl):7-9.
22. Wade OL. Plenary Lecture. In: Sjöqvist F, Agenäs I, editors. Drug Utilization Studies: Implications for Medical Practice. Proceedings from ANIS Symposium, Sånga-Säby, Sweden, 1982. Acta Med Scand 1983;683(suppl):7-9.
23. Andrews EB, Avorn J, Bortnichak EA, et al. Guidelines for good epidemiology practices for drug, device, and vaccine research in the United States. Pharmacoepidemiol Drug Saf 1996;5:333-338.
24. Strom BL, editor. Pharmacoepidemiology. 2nd ed. Chichester: Wiley, 1994.
25. Hasford J. Drug risk assessment: A case for large trials with lean protocols. Pharmacoepidemiol Drug Saf 1994;3:321-327.