Abdel Naser Zaid,1 Masshour Ghanem,2 Dua’a Shweiki,1 Hala Shtewi,1 Raja’ Shaheen,1 Sondos Al Helaly,1 Zeina Khayyat,1 Rowa’a Al Ramahi,1 Sa’ed H Zyoud1 1Department of Pharmacy, Faculty of Medicine & Health Sciences, An-Najah ...
Zaid AN+8 more
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Industry reneges on postmarketing trial commitments [PDF]
Aaron Bouchie
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Michele Jara, Thomas Aquilina, Peter Aupperle, Adrian L Rabinowicz Acorda Therapeutics, Inc., Ardsley, NY, USA Background: Dalfampridine extended release tablets (dalfampridine-ER; prolonged-, modified, or sustained-release fampridine outside the US ...
Jara M+3 more
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Regulating risks in pharmaceutical law : the need of an optimal interplay between products safety and products liability [PDF]
Published online: 7 June 2011The aim of this paper is to call for the need of a theoretical model of pharmaceutical products safety in which the two systems of regulation and liability operate complementarily. The question is why two legal tools that are
RIZZI, Marco
core
Results from a nationwide postmarketing cohort study of patients in Sweden treated with etanercept [PDF]
Nils Feltelius
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Postmarketing Surveillance: Review of Open Sources of Drug Safety Data
INTRODUCTION. Postmarketing surveillance is the main mechanism to monitor and evaluate the safety of drugs approved for widespread clinical use. This mechanism provides up-to-date information on adverse drug reactions and facilitates the implementation ...
E. V. Shubnikova
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Postmarketing Safety Surveillance for Typhoid Fever Vaccines from the Vaccine Adverse Event Reporting System, July 1990 through June 2002 [PDF]
Elizabeth Begier+3 more
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Systematic review about data quality and protocol compliance in clinical trials [PDF]
Bei Investigator Initiated Trials (IITs) werden alternative risikoadaptierte Monitoring-Strategien in Abhängigkeit vom individuellen Studiendesign und dem Risikoprofil diskutiert, um bei oft restriktiven Ressourcen eine den gesetzlichen Vorgaben ...
Brosteanu, Oana+9 more
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Postmarketing Surveillance for Ultracet® (Tramadol 37.5mg/Acetaminophen 325mg) [PDF]
Hye‐Soon Lee
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The Respective Roles of Controlled Clinical Trials and Cohort Monitoring Studies in the Pre- and Postmarketing Assessment of Drugs [PDF]
Muriel Vray+29 more
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