Sistema de Información Esencial en Terapéutica y Salud

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Última actualización: 18/9/2019
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2. Cita con resumen
Anónimo. FDA adds boxed warning for increased risk of death with gout medicine Uloric (febuxostat). U.S. Food and Drug Administration 2019:21 de febrero. [Ref.ID 103045]
3.Enlace a cita original Cita con resumen
Wallach JD, Eqilman AC, Dhruva SS, McCarthy ME, Miller JE, Woloshin S, Schwartz LM, Ross JS. Postmarket studies required by the US Food and Drug Administration for new drugs and biologics approved between 2009 and 2012: cross sectional analysis. BMJ 2018;361:24 de mayo. [Ref.ID 102886]
4.Enlace a cita originalTiene citas relacionadas Cita con resumen
Pacurariu A, Plueschke K, Olmo CA, Kurz X. Imposed registries within the European postmarketing surveillance system: Extended analysis and lessons learned for regulators. Pharmacoepidemiol Drug Saf 2018;27:julio. [Ref.ID 102879]
5. Cita con resumen
Busse WW, Bateman ED, Caplan AL, Kelly W, O'Byrne PM, Rabe KF, Chinchilli VM. Combined analysis of asthma safety trials of long-acting ß2-agonists. N Engl J Med 2018;378:2497-505. [Ref.ID 102733]
7. Cita con resumen
Go AS, Singer DE, Toh S, Cheetham TC, Reichman ME, Graham DJ, Southworth MR, Zhang R, Izem R, Goulding MR, Houstoun M, Mott K, Sung SH, Gagne JJ. Outcomes of dabigatran and warfarin for atrial fibrillation in contemporary practice: a retrospective cohort study. Ann Intern Med 2017;167:845-54. [Ref.ID 102196]
8.Tiene citas relacionadas Cita con resumen
Jonker CJ, van den Berg HM, Kwa MSG, Hoes AW, Mol PGM. Registries supporting new drug applications. Pharmacoepidemiol Drug Saf 2017;27:1451-7. [Ref.ID 102187]
9. Cita con resumen
Hamel MB. Speed, safety, and industry funding — From PDUFA I to PDUFA VI. N Engl J Med 2017;377:2278-86. [Ref.ID 102166]
11. Cita con resumen
Santoro A, Genov G, Spooner A, Raine J, Arlett P. Promoting and protecting public health: how the European Union pharmacovigilance system works. Drug Saf 2017;40:855-69. [Ref.ID 102075]
12. Cita con resumen
Woloshin S, Schwartz LM, White B, Moore TJ. The fate of FDA postapproval studies. N Engl J Med 2017;377:1114-7. [Ref.ID 102072]
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16. Cita con resumen
Engel P, Almas MF, De Bruin ML, Starzyk K, Blackburn S, Dreyer AN. Lessons learned on the design and the conduct of Post-Authorization Safety Studies: review of 3 years of PRAC oversight. Br J Clin Pharmacol 2017;83:884-93. [Ref.ID 101970]
17.Enlace a cita originalTiene citas relacionadas Cita con resumen
Bouvy JC, Blake K, Slattery J, De Bruin ML, Arlett P, Kurz X. Registries in European post-marketing surveillance: a retrospective analysis of centrally approved products, 2005–2013. Pharmacoepidemiol Drug Saf 2017;26:26 de marzo. [Ref.ID 101903]
18. Cita con resumen
Pease AM, Krumholz HM, Hines HH, Downing NS, Aminawung JA, Shah ND, Ross JS. Postapproval studies of drugs initially approved by the FDA on the basis of limited evidence: systematic review. BMJ 2017;357:j1680. [Ref.ID 101573]
19.Tiene citas relacionadas Cita con resumen
Spelsberg A , Prugger C , Doshi P , Ostrowski K , Witte T , Hüsgen D , Keil U , for the Working Group on Health and Working Group on Freedom of Information Transparency International Deutschland eV. Contribution of industry funded post-marketing studies to drug safety: survey of notifications submitted to regulatory agencies. BMJ 2017;356:j337. [Ref.ID 101390]
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