Literature DB >> 17186007

Biomarkers and surrogate end points for fit-for-purpose development and regulatory evaluation of new drugs.

J A Wagner1, S A Williams, C J Webster.   

Abstract

A consistent framework for the acceptance and qualification of biomarkers for regulatory use is needed to facilitate innovative and efficient research and subsequent application of biomarkers in drug development. One key activity is biomarker qualification, a graded, "fit-for-purpose" evidentiary process linking a biomarker with biology and clinical end points. A biomarker consortium model will distribute cost and risk, and drive efficient execution of research and ultimately regulatory acceptance of biomarkers for specific indications.

Mesh：

Substances：

Year:  2007        PMID： 17186007     DOI： 10.1038/sj.clpt.6100017

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


  59 in total

1.  Molecular staging estimates occult tumor burden in colorectal cancer.

Authors:  Alex Mejia; Stephanie Schulz; Terry Hyslop; David S Weinberg; Scott A Waldman
Journal:  Adv Clin Chem       Date:  2010       Impact factor: 5.394

2.  Towards consensus practices to qualify safety biomarkers for use in early drug development.

Authors:  Frank D Sistare; Frank Dieterle; Sean Troth; Daniel J Holder; David Gerhold; Dina Andrews-Cleavenger; William Baer; Graham Betton; Denise Bounous; Kevin Carl; Nathaniel Collins; Peter Goering; Federico Goodsaid; Yi-Zhong Gu; Valerie Guilpin; Ernie Harpur; Alita Hassan; David Jacobson-Kram; Peter Kasper; David Laurie; Beatriz Silva Lima; Romaldas Maciulaitis; William Mattes; Gérard Maurer; Leslie Ann Obert; Josef Ozer; Marisa Papaluca-Amati; Jonathan A Phillips; Mark Pinches; Matthew J Schipper; Karol L Thompson; Spiros Vamvakas; Jean-Marc Vidal; Jacky Vonderscher; Elizabeth Walker; Craig Webb; Yan Yu
Journal:  Nat Biotechnol       Date:  2010-05-10       Impact factor: 54.908

3.  Research at the interface of industry, academia and regulatory science.

Authors:  William B Mattes; Elizabeth Gribble Walker; Eric Abadie; Frank D Sistare; Jacky Vonderscher; Janet Woodcock; Raymond L Woosley
Journal:  Nat Biotechnol       Date:  2010-05       Impact factor: 54.908

4.  Applications of microRNA in cancer: Exploring the advantages of miRNA.

Authors:  Scott A Waldman; Andre Terzic
Journal:  Clin Transl Sci       Date:  2009-06       Impact factor: 4.689

5.  The roadmap to personalized medicine.

Authors:  Scott A Waldman; Andre Terzic
Journal:  Clin Transl Sci       Date:  2008-09       Impact factor: 4.689

6.  Molecular diagnostics. At the nexus of individualized medicine, health care delivery, and public policy.

Authors:  Scott A Waldman; Andre Terzic
Journal:  Clin Transl Sci       Date:  2009-02       Impact factor: 4.689

7.  Translational medicine in the era of health care reform.

Authors:  Scott A Waldman; Andre Terzic
Journal:  Clin Transl Sci       Date:  2009-04       Impact factor: 4.689

8.  Experimental therapeutics: a paradigm for personalized medicine.

Authors:  Scott A Waldman; Walter K Kraft; Timothy J Nelson; Andre Terzic
Journal:  Clin Transl Sci       Date:  2009-12       Impact factor: 4.689

Review 9.  Biomarkers and surrogate end points--the challenge of statistical validation.

Authors:  Marc Buyse; Daniel J Sargent; Axel Grothey; Alastair Matheson; Aimery de Gramont
Journal:  Nat Rev Clin Oncol       Date:  2010-04-06       Impact factor: 66.675

10.  Pharmacokinetics and pharmacodynamics of LC15-0444, a novel dipeptidyl peptidase IV inhibitor, after multiple dosing in healthy volunteers.

Authors:  Kyoung Soo Lim; Joo-Youn Cho; Bo-Hyung Kim; Jung-Ryul Kim; Hwa-Sook Kim; Dong-Kyu Kim; Sung-Ho Kim; Hyeon Joo Yim; Sung-Hack Lee; Sang-Goo Shin; In-Jin Jang; Kyung-Sang Yu
Journal:  Br J Clin Pharmacol       Date:  2009-12       Impact factor: 4.335
View more

北京卡尤迪生物科技股份有限公司 © 2022-2023.