Literature DB >> 25359359

Paving the critical path of drug development: the CDER perspective.

Janet Woodcock1.   

Abstract

Improving the science of drug development and regulation is important in fulfilling the public health mission of the US Food and Drug Administration (FDA). A decade on from the launch of the Critical Path Initiative, the FDA's Center for Drug Evaluation and Research (CDER) is now participating in more than 20 science-driven consortia to achieve this goal.

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Year:  2014        PMID： 25359359     DOI： 10.1038/nrd4435

Source DB:  PubMed          Journal:  Nat Rev Drug Discov        ISSN： 1474-1776            Impact factor:   84.694


  2 in total

1.  Curing consortium fatigue.

Authors:  Magdalini Papadaki; Gigi Hirsch
Journal:  Sci Transl Med       Date:  2013-08-28       Impact factor: 17.956

2.  Anticipated Ethics and Regulatory Challenges in PCORnet: The National Patient-Centered Clinical Research Network.

Authors:  Joseph Ali; Robert Califf; Jeremy Sugarman
Journal:  Account Res       Date:  2016       Impact factor: 2.622
  2 in total
  5 in total

Review 1.  Biomarker development in the context of urologic cancers.

Authors:  Gary J Kelloff; Caroline C Sigman; Howard I Scher
Journal:  Urol Oncol       Date:  2015-03-05       Impact factor: 3.498

Review 2.  Safety testing of monoclonal antibodies in non-human primates: Case studies highlighting their impact on human risk assessment.

Authors:  Frank R Brennan; Joy Cavagnaro; Kathleen McKeever; Patricia C Ryan; Melissa M Schutten; John Vahle; Gerhard F Weinbauer; Estelle Marrer-Berger; Lauren E Black
Journal:  MAbs       Date:  2017-10-26       Impact factor: 5.857

3.  Precompetitive Data Sharing as a Catalyst to Address Unmet Needs in Parkinson's Disease.

Authors:  Diane Stephenson; Michele T Hu; Klaus Romero; Kieran Breen; David Burn; Yoav Ben-Shlomo; Atul Bhattaram; Maria Isaac; Charles Venuto; Ken Kubota; Max A Little; Stephen Friend; Simon Lovestone; Huw R Morris; Donald Grosset; Margaret Sutherland; John Gallacher; Caroline Williams-Gray; Lisa J Bain; Enrique Avilés; Ken Marek; Arthur W Toga; Yafit Stark; Mark Forrest Gordon; Steve Ford
Journal:  J Parkinsons Dis       Date:  2015       Impact factor: 5.568

Review 4.  Cerebrospinal Fluid Biomarkers for Alzheimer's Disease: A View of the Regulatory Science Qualification Landscape from the Coalition Against Major Diseases CSF Biomarker Team.

Authors:  Stephen P Arnerić; Richard Batrla-Utermann; Laurel Beckett; Tobias Bittner; Kaj Blennow; Leslie Carter; Robert Dean; Sebastiaan Engelborghs; Just Genius; Mark Forrest Gordon; Janice Hitchcock; June Kaplow; Johan Luthman; Richard Meibach; David Raunig; Klaus Romero; Mahesh N Samtani; Mary Savage; Leslie Shaw; Diane Stephenson; Robert M Umek; Hugo Vanderstichele; Brian Willis; Susan Yule
Journal:  J Alzheimers Dis       Date:  2017       Impact factor: 4.472

Review 5.  Improving target assessment in biomedical research: the GOT-IT recommendations.

Authors:  Christoph H Emmerich; Lorena Martinez Gamboa; Martine C J Hofmann; Marc Bonin-Andresen; Olga Arbach; Pascal Schendel; Björn Gerlach; Katja Hempel; Anton Bespalov; Ulrich Dirnagl; Michael J Parnham
Journal:  Nat Rev Drug Discov       Date:  2020-11-16       Impact factor: 112.288
  5 in total

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