Li, Henry; Hanna, Kim
September 2012
AMWA Journal: American Medical Writers Association Journal;2012, Vol. 27 Issue 3, p116
Academic Journal
An abstract of the article "Preparing High-Quality Serious Adverse Event Narratives for Clinical Study Reports," by Henry Li and Kim Hanna is presented.


Related Articles

  • Conditional Approval and Approval Under Exceptional Circumstances as Regulatory Instruments for Stimulating Responsible Drug Innovation in Europe. Boon, W. P. C.; Moors, E. H. M.; Meijer, A.; Schellekens, H. // Clinical Pharmacology & Therapeutics;Dec2010, Vol. 88 Issue 6, p848 

    The need for fast drug innovation and the public demand for risk-free drugs creates a dilemma for regulatory authorities: less restrictive procedures involve uncertainties about benefit/risk profiles of new drugs. The European Union has introduced two instruments that regulate early market...

  • Memantine. Feret, Brett; Dicks, Robert // Formulary;Feb2004, Vol. 39 Issue 2, p91 

    Focuses on Memantine, an oral N-methyl-D-aspartate antagonist for the treatment of moderate-to-severe Alzheimer's disease. Chemistry and pharmacology of Memantine; Pharmacokinetic performance; Clinical trials conducted; Formulary considerations; Side-effects; Other-drug interaction; Dosing and...

  • A simple approach discriminating cardio-safe drugs from toxic ones. Falah, Mizied; Nassar, Taher; Rayan, Anwar // Bioinformation;2009, Vol. 3 Issue 9, p389 

    More than 130 FDA-approved drugs have been identified for now to prolong the QT interval and possibly lead to sudden cardiac death. Due to their toxic effect, some of these drugs have been withdrawn from the pharmaceutical market. In this study, we have formulated few rules to assess the ability...

  • Yellow card reports may lead to 'designer drugs'  // Pulse;7/28/2003, Vol. 63 Issue 30, p8 

    Reports that general practitioners' yellow card reports could soon be used to help pharmaceutical firms develop new medicine and that the government's Medicines and Healthcare Products Regulatory Agency will conduct review of dissemination of data on adverse reaction reports.

  • Effect of Safety Issues with HIV Drugs on the Approval Process of Other Drugs in the Same Class. Arnardottir, Ama H.; Haaijer-Ruskamp, Flora M.; Straus, Sabine M. J.; de Graeff, Pieter A.; Mol, Peter G. M. // Drug Safety;2011, Vol. 34 Issue 11, p1101 

    Background: Knowledge on the safety of new medicines is limited at the time of market entry. Nearly half of all drugs used to treat HIV registered in the EU required ≥1 Direct Healthcare Professional Communication (DHPC) in the past 10 years for safety issues identified post-approval....

  • Aranesp Cardio Risks May be Greater Than TREAT Reported. Young, Donna // BioWorld Today;10/15/2010, Vol. 21 Issue 200, p1 

    The article reports on the U.S. Food and Drug Administration's (FDA) rejection of the erythropoiesis-stimulating agent (ESA) Aranesp developed by Amgen Inc. According to the FDA, the cardiovascular and renal risks of the drug may be greater than what was earlier reported. The agency said it...

  • Licensing drugs for diabetes. Lehman, Richard; Yudkin, John S.; Krumholz, Harlan M. // BMJ: British Medical Journal (Overseas & Retired Doctors Edition;9/11/2010, Vol. 341 Issue 7772, p513 

    The authors call on regulatory agencies to require manufacturers of new drugs to provide definite evidence of greater benefits of their products than harm to patients. They cite the controversy over the safety of the diabetes drug rosiglitazone (Avandia) as an example of the failure of...

  • CNS News Round-up.  // PharmaWatch: Monthly Review;May2005, Vol. 4 Issue 5, p12 

    The article reports on the issues that surrounds drug developments for the treatment of diseases in the central nervous systems in the U.S. Biodec Idec has announced that its multiple sclerosis drug Avonex could put patients at risk of developing liver failure. On the other hand, Prana...

  • New therapeutic agents marketed in the first half of 2012: Part 2. Hussar, Daniel A. // Pharmacy Today;Nov2012, Vol. 18 Issue 11, p71 

    Objective: To provide infannation regarding the most important properties of the new therapeutic agents marketed in the first half of 2012. Data sources: Product labeling supplementcd sclcctivciy with published studies and drug information refercnce sources. Data silnthesis: 12 new therapeutic...


Read the Article


Sorry, but this item is not currently available from your library.

Try another library?
Sign out of this library

Other Topics