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Items: 17

1.

Prespecified falsification end points: can they validate true observational associations?

Prasad V, Jena AB.

JAMA. 2013 Jan 16;309(3):241-2. doi: 10.1001/jama.2012.96867. No abstract available.

PMID:
23321761
2.

Updating the French method for the causality assessment of adverse drug reactions.

Arimone Y, Bidault I, Dutertre JP, Gérardin M, Guy C, Haramburu F, Hillaire-Buys D, Meglio C, Penfornis C, Théophile H, Valnet-Rabier MB; Cercle de Réflexion sur l’Imputabilité (CRI)..

Therapie. 2013 Mar-Apr;68(2):69-76. doi: 10.2515/therapie/2013016. Review.

PMID:
23773347
3.

Design and analysis of post-marketing research.

Zhou XH, Yang W.

Chin J Integr Med. 2013 Jul;19(7):488-93. doi: 10.1007/s11655-013-1501-z. Review.

PMID:
23818199
4.

Is the large simple trial design used for comparative, post-approval safety research? A review of a clinical trials registry and the published literature.

Reynolds RF, Lem JA, Gatto NM, Eng SM.

Drug Saf. 2011 Oct 1;34(10):799-820. doi: 10.2165/11593820-000000000-00000. Review.

PMID:
21879776
5.

Does proof of casualty ever exist in pharmacovigilance?

Auriche M, Loupi E.

Drug Saf. 1993 Sep;9(3):230-5. Review.

PMID:
8240728
6.

Active surveillance for adverse events following immunization.

Crawford NW, Clothier H, Hodgson K, Selvaraj G, Easton ML, Buttery JP.

Expert Rev Vaccines. 2014 Feb;13(2):265-76. doi: 10.1586/14760584.2014.866895. Review.

PMID:
24350637
7.

Causality assessment of adverse effects: when is re-challenge ethically acceptable?

Po AL, Kendall MJ.

Drug Saf. 2001;24(11):793-9. Review.

PMID:
11665867
8.

[Safety of medicinal products and reporting of adverse drug reactions].

Skibicka I, Maciejczyk A.

Neurol Neurochir Pol. 2004 Nov-Dec;38(6):503-10. Review. Polish.

PMID:
15654675
9.

Novel procedures for validating surrogate endpoints in clinical trials.

Cleophas TJ, Zwinderman AH, Chaib AH.

Curr Clin Pharmacol. 2007 May;2(2):123-8. Review.

PMID:
18690859
10.

Principles of signal detection in pharmacovigilance.

Meyboom RH, Egberts AC, Edwards IR, Hekster YA, de Koning FH, Gribnau FW.

Drug Saf. 1997 Jun;16(6):355-65. Review.

PMID:
9241490
11.

Commentary by a child psychiatrist in industry on the assessment of drug safety.

Allen AJ.

J Child Adolesc Psychopharmacol. 2007 Jun;17(3):288-91. Review. No abstract available.

PMID:
17630860
12.

Role of postmarketing surveillance in contemporary medicine.

Woodcock J, Behrman RE, Dal Pan GJ.

Annu Rev Med. 2011;62:1-10. doi: 10.1146/annurev-med-060309-164311. Review.

PMID:
20809798
13.

An overview of pharmacoepidemiology.

Wertheimer AL, Andrews KB.

Pharm World Sci. 1995 May 26;17(3):61-6. Review.

PMID:
7550051
14.

Perspectives on the future of postmarket vaccine safety surveillance and evaluation.

Ball R.

Expert Rev Vaccines. 2014 Apr;13(4):455-62. Review.

PMID:
24606417
15.

A pathway to improved prospective observational post-authorization safety studies.

Kiri VA.

Drug Saf. 2012 Sep 1;35(9):711-24. doi: 10.2165/11630570-000000000-00000. Review.

PMID:
22861669
16.

Postmarketing surveillance for drug abuse.

Arfken CL, Cicero TJ.

Drug Alcohol Depend. 2003 Jun 5;70(3 Suppl):S97-105. Review.

PMID:
12759200
17.

Assessing causality in drug-induced liver injury.

Lee WM.

J Hepatol. 2000 Dec;33(6):1003-5. Review. No abstract available.

PMID:
11131436
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