Literature DB >> 24126858

How to access and process FDA drug approval packages for use in research.

Erick H Turner1.   

Abstract

Mesh：

Year:  2013        PMID： 24126858     DOI： 10.1136/bmj.f5992

Source DB:  PubMed          Journal:  BMJ        ISSN： 0959-8138


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  16 in total

1.  Rapid network meta-analysis using data from Food and Drug Administration approval packages is feasible but with limitations.

Authors:  Lin Wang; Benjamin Rouse; Arielle Marks-Anglin; Rui Duan; Qiyuan Shi; Kevin Quach; Yong Chen; Christopher Cameron; Christopher H Schmid; Tianjing Li
Journal:  J Clin Epidemiol       Date:  2019-06-18       Impact factor: 6.437

2.  Beyond PubMed: Searching the "Grey Literature" for Clinical Trial Results.

Authors:  Leslie Citrome
Journal:  Innov Clin Neurosci       Date:  2014-07

3.  Toward evidence-based medical statistics: a Bayesian analysis of double-blind placebo-controlled antidepressant trials in the treatment of anxiety disorders.

Authors:  Rei Monden; Stijn de Vos; Richard Morey; Eric-Jan Wagenmakers; Peter de Jonge; Annelieke M Roest
Journal:  Int J Methods Psychiatr Res       Date:  2016-05-24       Impact factor: 4.035

Review 4.  Standards for design and measurement would make clinical research reproducible and usable.

Authors:  Kay Dickersin; Evan Mayo-Wilson
Journal:  Proc Natl Acad Sci U S A       Date:  2018-03-13       Impact factor: 11.205

5.  Consensus recommendations for systematic evaluation of drug-drug interaction evidence for clinical decision support.

Authors:  Richard T Scheife; Lisa E Hines; Richard D Boyce; Sophie P Chung; Jeremiah D Momper; Christine D Sommer; Darrell R Abernethy; John R Horn; Stephen J Sklar; Samantha K Wong; Gretchen Jones; Mary L Brown; Amy J Grizzle; Susan Comes; Tricia Lee Wilkins; Clarissa Borst; Michael A Wittie; Daniel C Malone
Journal:  Drug Saf       Date:  2015-02       Impact factor: 5.606

6.  Use of Expansion Cohorts in Phase I Trials and Probability of Success in Phase II for 381 Anticancer Drugs.

Authors:  Diogo D G Bugano; Kenneth Hess; Denis L F Jardim; Alona Zer; Funda Meric-Bernstam; Lillian L Siu; Albiruni R A Razak; David S Hong
Journal:  Clin Cancer Res       Date:  2017-04-04       Impact factor: 12.531

7.  ClinicalTrials.gov and Drugs@FDA: A Comparison of Results Reporting for New Drug Approval Trials.

Authors:  Lisa M Schwartz; Steven Woloshin; Eugene Zheng; Tony Tse; Deborah A Zarin
Journal:  Ann Intern Med       Date:  2016-06-14       Impact factor: 25.391

8.  Integrating multiple data sources (MUDS) for meta-analysis to improve patient-centered outcomes research: a protocol.

Authors:  Evan Mayo-Wilson; Susan Hutfless; Tianjing Li; Gillian Gresham; Nicole Fusco; Jeffrey Ehmsen; James Heyward; Swaroop Vedula; Diana Lock; Jennifer Haythornthwaite; Jennifer L Payne; Theresa Cowley; Elizabeth Tolbert; Lori Rosman; Claire Twose; Elizabeth A Stuart; Hwanhee Hong; Peter Doshi; Catalina Suarez-Cuervo; Sonal Singh; Kay Dickersin
Journal:  Syst Rev       Date:  2015-11-02

9.  Spin in RCTs of anxiety medication with a positive primary outcome: a comparison of concerns expressed by the US FDA and in the published literature.

Authors:  Lian Beijers; Bertus F Jeronimus; Erick H Turner; Peter de Jonge; Annelieke M Roest
Journal:  BMJ Open       Date:  2017-03-29       Impact factor: 2.692

10.  The ChEMBL database in 2017.

Authors:  Anna Gaulton; Anne Hersey; Michał Nowotka; A Patrícia Bento; Jon Chambers; David Mendez; Prudence Mutowo; Francis Atkinson; Louisa J Bellis; Elena Cibrián-Uhalte; Mark Davies; Nathan Dedman; Anneli Karlsson; María Paula Magariños; John P Overington; George Papadatos; Ines Smit; Andrew R Leach
Journal:  Nucleic Acids Res       Date:  2016-11-28       Impact factor: 16.971
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