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Items: 1 to 20 of 135

1.

Serious adverse drug events related to non-investigational drugs in academic clinical trials: another source of safety data for risk assessment?

Olivier P, Gimbert A, Colin AL, Salvo F, Becker M, Marty V, Montastruc JL, Petitpain N.

Br J Clin Pharmacol. 2016 Oct;82(4):1069-75. doi: 10.1111/bcp.13035. Epub 2016 Jul 13.

2.

Sponsors' and investigative staffs' perceptions of the current investigational new drug safety reporting process in oncology trials.

Perez R, Archdeacon P, Roach N, Goodwin R, Jarow J, Stuccio N, Forrest A.

Clin Trials. 2017 Jun;14(3):225-233. doi: 10.1177/1740774517700640. Epub 2017 Mar 26.

3.

Factors affecting the causality assessment of adverse events following immunisation in paediatric clinical trials: An online survey.

Voysey M, Tavana R, Farooq Y, Heath PT, Bonhoeffer J, Snape MD.

Vaccine. 2015 Dec 16;33(51):7203-7210. doi: 10.1016/j.vaccine.2015.10.126. Epub 2015 Nov 6.

PMID:
26552002
4.

Quality of serious adverse events reporting to academic sponsors of clinical trials: far from optimal.

Crépin S, Villeneuve C, Merle L.

Pharmacoepidemiol Drug Saf. 2016 Jun;25(6):719-24. doi: 10.1002/pds.3982. Epub 2016 Feb 17.

PMID:
26887649
5.

[Recording and reporting adverse reactions in clinical trials. New legal provisions according to the 12th Law Amending the German Drug Law (AMG) and the Ordinance on GCP (GCP-V)].

Eckhardt K, Cremer-Schaeffer P, König J, Paeschke N.

Bundesgesundheitsblatt Gesundheitsforschung Gesundheitsschutz. 2005 Feb;48(2):173-80. German.

PMID:
15726458
6.

A survey of spontaneous reporting of adverse drug reactions in 10 years of activity in a pharmacovigilance centre in Portugal.

Marques J, Ribeiro-Vaz I, Pereira AC, Polónia J.

Int J Pharm Pract. 2014 Aug;22(4):275-82. doi: 10.1111/ijpp.12078. Epub 2013 Nov 5.

PMID:
24188533
7.

[Adverse drug reactions in pediatrics: Experience of a regional pharmacovigilance center].

Saint-Martin C, Kanagaratnam L, de Boissieu P, Azzouz B, Abou Taam M, Trenque T.

Therapie. 2016 Oct;71(5):467-473. doi: 10.1016/j.therap.2016.04.001. Epub 2016 Apr 11. French.

PMID:
27203165
8.

Drug-induced adverse reactions via breastfeeding: a descriptive study in the French Pharmacovigilance Database.

Soussan C, Gouraud A, Portolan G, Jean-Pastor MJ, Pecriaux C, Montastruc JL, Damase-Michel C, Lacroix I.

Eur J Clin Pharmacol. 2014 Nov;70(11):1361-6. doi: 10.1007/s00228-014-1738-2. Epub 2014 Sep 4.

PMID:
25183382
9.

[Evaluation of tolerance to endovesical BCG treatment in France: analysis of severe adverse effects notified in 3 years].

Debois H, Loupi E, Saliou P, Blangy H, Loeuille D, Gillet P.

Prog Urol. 2001 Jun;11(3):458-65. French.

PMID:
11512458
10.

Pharmacoepidemiology and its input to pharmacovigilance.

Faillie JL, Montastruc F, Montastruc JL, Pariente A.

Therapie. 2016 Apr;71(2):211-6. doi: 10.1016/j.therap.2016.02.016. Epub 2016 Feb 6. English, French.

PMID:
27080840
11.

Causality Assessment in Premarketing Drug Clinical Trials: Regulatory Evolution in the USA and Ongoing Concerns.

Goldman SA.

Drug Saf. 2016 Oct;39(10):895-901. doi: 10.1007/s40264-016-0442-9.

PMID:
27473417
12.

Importance of cytochrome P450 (CYP450) in adverse drug reactions due to drug-drug interactions: a PharmacoVigilance study in France.

Danton AC, Montastruc F, Sommet A, Durrieu G, Bagheri H, Bondon-Guitton E, Lapeyre-Mestre M, Montastruc JL.

Eur J Clin Pharmacol. 2013 Apr;69(4):885-8. doi: 10.1007/s00228-012-1394-3. Epub 2012 Sep 21.

PMID:
22996074
13.

Bevacizumab-induced serious side-effects: a review of the French pharmacovigilance database.

Taugourdeau-Raymond S, Rouby F, Default A, Jean-Pastor MJ; French Network of Pharmacovigilance Centers.

Eur J Clin Pharmacol. 2012 Jul;68(7):1103-7. doi: 10.1007/s00228-012-1232-7. Epub 2012 Feb 16.

PMID:
22349162
14.

Evaluation of patient reporting of adverse drug reactions to the UK 'Yellow Card Scheme': literature review, descriptive and qualitative analyses, and questionnaire surveys.

Avery AJ, Anderson C, Bond CM, Fortnum H, Gifford A, Hannaford PC, Hazell L, Krska J, Lee AJ, McLernon DJ, Murphy E, Shakir S, Watson MC.

Health Technol Assess. 2011 May;15(20):1-234, iii-iv. doi: 10.3310/hta15200. Review.

15.

Gingival bleeding, a possible "serious" adverse drug reaction: An observational study in the French PharmacoVigilance Database.

Bondon-Guitton E, Mourgues T, Rousseau V, Cousty S, Cottin J, Drablier G, Micallef J, Montastruc JL.

J Clin Periodontol. 2017 Sep;44(9):898-904. doi: 10.1111/jcpe.12770. Epub 2017 Aug 11.

PMID:
28667742
16.

The suspected unexpected and serious adverse events of antiretroviral drugs used as HIV prophylaxis in HIV uninfected persons.

Pietraszkiewicz E, Firlag-Burkacka E, Horban A, Kowalska JD.

J Int AIDS Soc. 2014 Nov 2;17(4 Suppl 3):19733. doi: 10.7448/IAS.17.4.19733. eCollection 2014.

17.

Comparison of serious adverse events posted at ClinicalTrials.gov and published in corresponding journal articles.

Tang E, Ravaud P, Riveros C, Perrodeau E, Dechartres A.

BMC Med. 2015 Aug 14;13:189. doi: 10.1186/s12916-015-0430-4.

18.

[Drug-induced pancreatitis. A review of French spontaneous reports].

Chebane L, Bagheri H, Hillaire-Buys D, Géniaux H, Yahioui N, Laroche ML, Cottin J, Spreux A, Mosquet B, Pecriaux C, Bellet F, Lambert A, Montastruc JL.

Rev Med Interne. 2015 Sep;36(9):573-8. doi: 10.1016/j.revmed.2015.04.012. Epub 2015 Jun 1. Review. French.

PMID:
26045335
19.

Drug interactions between antihypertensive drugs and non-steroidal anti-inflammatory agents: a descriptive study using the French Pharmacovigilance database.

Fournier JP, Sommet A, Durrieu G, Poutrain JC, Lapeyre-Mestre M, Montastruc JL; French Network of Regional Pharmacovigilance Centres.

Fundam Clin Pharmacol. 2014 Apr;28(2):230-5. doi: 10.1111/fcp.12014. Epub 2012 Nov 28.

PMID:
23190210
20.

Neonatal adverse drug reactions: an analysis of reports to the French pharmacovigilance database.

Kaguelidou F, Beau-Salinas F, Jonville-Bera AP, Jacqz-Aigrain E.

Br J Clin Pharmacol. 2016 Oct;82(4):1058-68. doi: 10.1111/bcp.13034. Epub 2016 Jul 24.

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