US Activities in Risk Management of Pharmaceutical Products

Pharmacovigilance: Second Edition

Volumn , Issue , 2007, Pages 533-552

  Bull, Jonca ^a  

^a CENTER FOR DRUG EVALUATION AND RESEARCH   (United States)

Author keywords

FDCA and FDA regulations for post marketing risk assessment; Identifying and describing safety signals; Pharmaceutical product risk management; Pharmacovigilance and pharmacoepidemiology role in risk management; Premarketing Guidance and Pharmacovigilance Guidance

Indexed keywords

EID: 84859209703     PISSN: None     EISSN: None     Source Type: Book    
DOI: 10.1002/9780470059210.ch43     Document Type: Chapter

References (12)

1. Bate A, Lindquist M, Edwards IR et al., 1998, 'A Bayesian neural network method for adverse drug reaction signal generation', European Journal of Clinical Pharmacology 54:315-21.
2. Cohen MR (ed), 1999, Medication Errors. American Pharmaceutical Association, Washington DC
3. Cousins DD (ed) (1998) Medication Use: A Systems Approach to Reducing Errors. Joint Commission on Accreditation of Healthcare Organizations, Oakbrook Terrace, IL.
4. DuMouchel W and Pregibon D, 2001, 'Empirical Bayes screening for multi-item associations', Seventh ACM SigKDD International Conference on Knowledge Discovery and Data Mining.
5. Evans SJW, Waller P and Davis S, 1998, 'Proportional reporting ratios: the uses of epidemiological methods for signal generation [abstract]', Pharmacoepidemiology and Drug Safety 7:S102.
6. Evans SJ, 2000, 'Pharmacovigilance: A science or fielding emergencies?' Statistics in Medicine 19(23):3199-209;
7. Evans SJW, Waller PC and Davis S, 2001, 'Use of proportional reporting ratios (PRRs) for signal generation from spontaneous adverse drug reaction reports', Pharmacoepidemiology and Drug Safety 10:483-6.
8. Gostin, L. 'Public Health Law in a New Century', 2000, Journal of the American Medical Association, 283(23): 3118-22.
9. Rodriguez EM, Staffa JA and Graham DJ, 2001, 'The role of databases in drug postmarketing surveillance', Pharmacoepidemiology and Drug Safety, 10:407-10.
10. Szarfman A, Machado SG and O'Neill RT, 2002, 'Use of screening algorithms and computer systems to efficiently signal higher-than-expected combinations of drugs and events in the US FDA's spontaneous reports database', Drug Safety 25(6): 381-92.
11. Strom BL (ed), 2000, Pharmacoepidemiology, 3rd edition, John Wiley and Sons, Ltd, Chichester;
12. Hartzema AG, Porta M and Tilson HH (eds), 1998, Pharmacoepidemiology: An Introduction, 3rd edition, Harvey Whitney Books, Cincinnati, OH.