Literature DB >> 20407457

The Critical Path Institute's approach to precompetitive sharing and advancing regulatory science.

R L Woosley1, R T Myers, F Goodsaid.   

Abstract

Many successful large industries, such as computer-chip manufacturers, the cable television industry, and high-definition television developers,(1) have established successful precompetitive collaborations focusing on standards, applied science, and technology that advance the field for all stakeholders and benefit the public.(2) The pharmaceutical industry, however, has a well-earned reputation for fierce competition and did not demonstrate willingness to share data or knowledge until the US Food and Drug Administration (FDA) launched the Critical Path Initiative in 2004 (ref. 3).

Mesh:

Year:  2010        PMID: 20407457     DOI: 10.1038/clpt.2010.27

Source DB:  PubMed          Journal:  Clin Pharmacol Ther        ISSN: 0009-9236            Impact factor:   6.875


  7 in total

1.  Drug Discovery in Academia- the third way?

Authors:  Julie Frearson; Paul Wyatt
Journal:  Expert Opin Drug Discov       Date:  2010-10-01       Impact factor: 6.098

2.  Data standards for model-informed drug development: an ISoP initiative.

Authors:  Andrijana Radivojevic; Brian Corrigan; Nicholas Downie; Robert Fox; Jill Fiedler-Kelly; Huan Liu; Murad Melhem; David Radke; Peter Schaefer; Jing Su; Maciej J Swat; Nathan S Teuscher; Neelima Thanneer; Alice Zong; Justin J Wilkins
Journal:  J Pharmacokinet Pharmacodyn       Date:  2018-07-25       Impact factor: 2.745

3.  Elements for adequate informed consent in the surgical context.

Authors:  Hernando Abaunza; Klaus Romero
Journal:  World J Surg       Date:  2014-07       Impact factor: 3.352

4.  Food and Drug Administration perspective: Advancing product development for non-healing chronic wounds.

Authors:  Kapil Dev Verma; Felisa Lewis; Maryjoy Mejia; Meghana Chalasani; Kendall A Marcus
Journal:  Wound Repair Regen       Date:  2022-04-06       Impact factor: 3.401

5.  Food and drug administration's critical path initiative and innovations in drug development paradigm: Challenges, progress, and controversies.

Authors:  Rajiv Mahajan; Kapil Gupta
Journal:  J Pharm Bioallied Sci       Date:  2010-10

6.  Where will the (New) Drugs for Traumatic Brain Injury Treatment be Coming From?

Authors:  Denes V Agoston; Mårten Risling
Journal:  Front Neurol       Date:  2012-03-02       Impact factor: 4.003

Review 7.  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

  7 in total

北京卡尤迪生物科技股份有限公司 © 2022-2023.