Testing for adverse reactions using prescription event monitoring

Statistics in Medicine

Volumn 15, Issue 10, 1996, Pages 987-1002

  Andrew, J E ^a,c   Prescott, P ^a   Smith, T M F ^a   Inman, W H W ^b   Kubota, K ^b  

^a UNIVERSITY OF SOUTHAMPTON   (United Kingdom)

^b DRUG SAFETY RESEARCH UNIT   (United Kingdom)

^c ASTRAZENECA   (United Kingdom)

Author keywords

[No Author keywords available]

Indexed keywords

NEW DRUG;

ADVERSE DRUG REACTION; ARTICLE; DRUG SAFETY; METHODOLOGY; MODEL; MONITORING; PRESCRIPTION; TIME;

ADVERSE DRUG REACTION REPORTING SYSTEMS; BIAS (EPIDEMIOLOGY); DATA COLLECTION; HUMANS; MODELS, STATISTICAL; OBSERVATION; PRESCRIPTIONS, DRUG; PROBABILITY THEORY; QUESTIONNAIRES;

EID: 0030005472     PISSN: 02776715     EISSN: None     Source Type: Journal    
DOI: 10.1002/(SICI)1097-0258(19960530)15:10<987::AID-SIM210>3.0.CO;2-G     Document Type: Article

References (7)

1. O'Neill, R. T. 'Assessment of safety', in Peace, K. E. (ed), Biopharamaceutical Statistics for Drug Development, Marcel Dekker, New York, 1987.
2. Inman, W. H. W. Monitoring for Drug Safety, 1st edn, MTP Press Ltd, Lancaster, 1980.
3. Norwood, P. K. and Sampson, A. R. 'A statistical methodology for postmarketing surveillance of adverse drug reaction reports', Statistics in Medicine, 7, 1023-1030 (1988).
4. Inman, W. H. W. and Pearce, G. 'Prescriber profile and post-marketing surveillance', Lancet, 342, 658-661 (1993).
5. Kleinbaum, D. G., Kupper, L. L. and Morgenstern, H. Epidemiologic Research. Principles and Quantitative methods, London, 1982.
6. Drug Safety Research Unit. Nicardipine, PEM Report No 1, Southampton, 1991.
7. Andrew, J. E. 'The detection of adverse reactions to drugs using prescription-event monitoring', MSc Statistics with Applications in Medicine dissertation, Southampton University, 1992.