Literature DB >> 20458309

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

William B Mattes1, Elizabeth Gribble Walker, Eric Abadie, Frank D Sistare, Jacky Vonderscher, Janet Woodcock, Raymond L Woosley.   

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Year:  2010        PMID： 20458309     DOI： 10.1038/nbt0510-432

Source DB:  PubMed          Journal:  Nat Biotechnol        ISSN： 1087-0156            Impact factor:   54.908


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  24 in total

1.  Drug development and the FDA's Critical Path Initiative.

Authors:  R L Woosley; J Cossman
Journal:  Clin Pharmacol Ther       Date:  2007-01       Impact factor: 6.875

2.  The history and contemporary challenges of the US Food and Drug Administration.

Authors:  Andrea T Borchers; Frank Hagie; Carl L Keen; M Eric Gershwin
Journal:  Clin Ther       Date:  2007-01       Impact factor: 3.393

Review 3.  Promises of biomarkers in drug development--a reality check.

Authors:  Estelle Marrer; Frank Dieterle
Journal:  Chem Biol Drug Des       Date:  2007-06       Impact factor: 2.817

Review 4.  Strategic approach to fit-for-purpose biomarkers in drug development.

Authors:  John A Wagner
Journal:  Annu Rev Pharmacol Toxicol       Date:  2008       Impact factor: 13.820

5.  Personalized medicine: elusive dream or imminent reality?

Authors:  L J Lesko
Journal:  Clin Pharmacol Ther       Date:  2007-06       Impact factor: 6.875

6.  Serum activity of alanine aminotransferase (ALT) as an indicator of health and disease.

Authors:  W Ray Kim; Steven L Flamm; Adrian M Di Bisceglie; Henry C Bodenheimer
Journal:  Hepatology       Date:  2008-04       Impact factor: 17.425

7.  Sematech: purpose and performance.

Authors:  D A Irwin; P J Klenow
Journal:  Proc Natl Acad Sci U S A       Date:  1996-11-12       Impact factor: 11.205

8.  Science, law and society: the pursuit of food safety.

Authors:  S A Miller
Journal:  J Nutr       Date:  1993-02       Impact factor: 4.798

Review 9.  Do preclinical testing strategies help predict human hepatotoxic potentials?

Authors:  Terry S Peters
Journal:  Toxicol Pathol       Date:  2005       Impact factor: 1.902

Review 10.  Human carcinogenic risk evaluation, Part III: Assessing cancer hazard and risk in human drug development.

Authors:  Abigail Jacobs; David Jacobson-Kram
Journal:  Toxicol Sci       Date:  2004-05-12       Impact factor: 4.849
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  4 in total

1.  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

2.  Pharma embraces open source models.

Authors:  Stephen Strauss
Journal:  Nat Biotechnol       Date:  2010-07       Impact factor: 54.908

Review 3.  Regulatory landscapes for biomarkers and diagnostic tests: Qualification, approval, and role in clinical practice.

Authors:  William B Mattes; Federico Goodsaid
Journal:  Exp Biol Med (Maywood)       Date:  2017-11-07

4.  Quantitative mass spectrometry of urinary biomarkers.

Authors:  Marina Jerebtsova; Sergei Nekhai
Journal:  J Integr OMICS       Date:  2014-12-01
  4 in total

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