Literature DB >> 26606966

Unmet needs: Research helps regulators do their jobs.

Russ B Altman1, Natalia Khuri2, Marc Salit3, Kathleen M Giacomini4.   

Abstract

A plethora of innovative new medical products along with the need to apply modern technologies to medical-product evaluation has spurred seminal opportunities in regulatory sciences. Here, we provide eight examples of regulatory science research for diverse products. Opportunities abound, particularly in data science and precision health.
Copyright © 2015, American Association for the Advancement of Science.

Mesh：

Year:  2015        PMID： 26606966     DOI： 10.1126/scitranslmed.aac4369

Source DB:  PubMed          Journal:  Sci Transl Med        ISSN： 1946-6234            Impact factor:   17.956


  5 in total

Review 1.  Towards precision medicine.

Authors:  Euan A Ashley
Journal:  Nat Rev Genet       Date:  2016-08-16       Impact factor: 53.242

2.  Transporters in Regulatory Science: Notable Contributions from Dr. Giacomini in the Past Two Decades.

Authors:  Lei Zhang; Qi Liu; Shiew-Mei Huang; Robert Lionberger
Journal:  Drug Metab Dispos       Date:  2022-06-29       Impact factor: 3.579

Review 3.  Omics-Based Strategies in Precision Medicine: Toward a Paradigm Shift in Inborn Errors of Metabolism Investigations.

Authors:  Abdellah Tebani; Carlos Afonso; Stéphane Marret; Soumeya Bekri
Journal:  Int J Mol Sci       Date:  2016-09-14       Impact factor: 5.923

4.  Regulatory Science and Innovation Programme for Europe (ReScIPE): A proposed model.

Authors:  Philip A Hines; Richard H Guy; Angela Brand; Anthony J Humphreys; Marisa Papaluca-Amati
Journal:  Br J Clin Pharmacol       Date:  2019-10-17       Impact factor: 4.335

5.  One in seven pathogenic variants can be challenging to detect by NGS: an analysis of 450,000 patients with implications for clinical sensitivity and genetic test implementation.

Authors:  Stephen E Lincoln; Tina Hambuch; Justin M Zook; Sara L Bristow; Kathryn Hatchell; Rebecca Truty; Michael Kennemer; Brian H Shirts; Andrew Fellowes; Shimul Chowdhury; Eric W Klee; Shazia Mahamdallie; Megan H Cleveland; Peter M Vallone; Yan Ding; Sheila Seal; Wasanthi DeSilva; Farol L Tomson; Catherine Huang; Russell K Garlick; Nazneen Rahman; Marc Salit; Stephen F Kingsmore; Matthew J Ferber; Swaroop Aradhya; Robert L Nussbaum
Journal:  Genet Med       Date:  2021-05-18       Impact factor: 8.822
  5 in total

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