The Predictive Safety Testing Consortium and the Coalition Against Major Diseases

被引：8

作者：

Stephenson, Diane ^{[1
]}

Sauer, John-Michael ^{[2
]}

机构：

[1] Crit Path Inst, CAMD, Tucson, AZ 85718 USA

[2] Crit Path Inst, PSTC, Tucson, AZ 85718 USA

来源：

NATURE REVIEWS DRUG DISCOVERY | 2014年 / 13卷 / 11期

关键词：

BIOMARKER QUALIFICATION; ALZHEIMERS-DISEASE; CLINICAL-TRIALS;

D O I：

10.1038/nrd4440

中图分类号：

Q81 [生物工程学（生物技术）]; Q93 [微生物学];

学科分类号：

071005 [微生物学]; 090105 [作物生产系统与生态工程];

摘要：

The Predictive Safety Testing Consortium and the Coalition Against Major Diseases, both launched by the Critical Path Institute, provide valuable examples of the outcomes and lessons learned by different types of consortia working on new drug development tools.

引用

页码：793 / 794

页数：2

共 4 条

[1]

Renal biomarker qualification submission: a dialog between the FDA-EMEA and Predictive Safety Testing Consortium [J].

Dieterle, Frank ;

Sistare, Frank ;

Goodsaid, Federico ;

Papaluca, Marisa ;

Ozer, Josef S. ;

Webb, Craig P. ;

Baer, William ;

Senagore, Anthony ;

Schipper, Matthew J. ;

Vonderscher, Jacky ;

Sultana, Stefan ;

Gerhold, David L. ;

Phillips, Jonathan A. ;

Maurer, Gerard ;

Carl, Kevin ;

Laurie, David ;

Harpur, Ernie ;

Sonee, Manisha ;

Ennulat, Daniela ;

Holder, Dan ;

Andrews-Cleavenger, Dina ;

Gu, Yi-Zhong ;

Thompson, Karol L. ;

Goering, Peter L. ;

Vidal, Jean-Marc ;

Abadie, Eric ;

Maciulaitis, Romaldas ;

Jacobson-Kram, David ;

Defelice, Albert F. ;

Hausner, Elizabeth A. ;

Blank, Melanie ;

Thompson, Aliza ;

Harlow, Patricia ;

Throckmorton, Douglas ;

Xiao, Shen ;

Xu, Nancy ;

Taylor, William ;

Vamvakas, Spiros ;

Flamion, Bruno ;

Lima, Beatriz Silva ;

Kasper, Peter ;

Pasanen, Markku ;

Prasad, Krishna ;

Troth, Sean ;

Bounous, Denise ;

Robinson-Gravatt, Denise ;

Betton, Graham ;

Davis, Myrtle A. ;

Akunda, Jackie ;

McDuffie, James Eric .

NATURE BIOTECHNOLOGY, 2010, 28 (05) :455-462

[2]

Coalition Against Major Diseases/European Medicines Agency biomarker qualification of hippocampal volume for enrichment of clinical trials in predementia stages of Alzheimer's disease [J].

Hill, Derek L. G. ;

Schwarz, Adam J. ;

Isaac, Maria ;

Pani, Luca ;

Vamvakas, Spiros ;

Hemmings, Robert ;

Carrillo, Maria C. ;

Yu, Peng ;

Sun, Jia ;

Beckett, Laurel ;

Boccardi, Marina ;

Brewer, James ;

Brumfield, Martha ;

Cantillon, Marc ;

Cole, Patricia E. ;

Fox, Nick ;

Frisoni, Giovanni B. ;

Jack, Clifford ;

Kelleher, Thomas ;

Luo, Feng ;

Novak, Gerald ;

Maguire, Paul ;

Meibach, Richard ;

Patterson, Patricia ;

Bain, Lisa ;

Sampaio, Cristina ;

Raunig, David ;

Soares, Holly ;

Suhy, Joyce ;

Wang, Huanli ;

Wolz, Robin ;

Stephenson, Diane .

ALZHEIMERS & DEMENTIA, 2014, 10 (04) :421-429

[3]

Understanding Placebo Responses in Alzheimer's Disease Clinical Trials from the Literature Meta-Data and CAMD Database [J].

Ito, Kaori ;

Corrigan, Brian ;

Romero, Klaus ;

Anziano, Richard ;

Neville, Jon ;

Stephenson, Diane ;

Lalonde, Richard .

JOURNAL OF ALZHEIMERS DISEASE, 2013, 37 (01) :173-183

[4]

Towards consensus practices to qualify safety biomarkers for use in early drug development [J].

Sistare, Frank D. ;

Dieterle, Frank ;

Troth, Sean ;

Holder, Daniel J. ;

Gerhold, David ;

Andrews-Cleavenger, Dina ;

Baer, William ;

Betton, Graham ;

Bounous, Denise ;

Carl, Kevin ;

Collins, Nathaniel ;

Goering, Peter ;

Goodsaid, Federico ;

Gu, Yi-Zhong ;

Guilpin, Valerie ;

Harpur, Ernie ;

Hassan, Alita ;

Jacobson-Kram, David ;

Kasper, Peter ;

Laurie, David ;

Lima, Beatriz Silva ;

Maciulaitis, Romaldas ;

Mattes, William ;

Maurer, Gerard ;

Obert, Leslie Ann ;

Ozer, Josef ;

Papaluca-Amati, Marisa ;

Phillips, Jonathan A. ;

Pinches, Mark ;

Schipper, Matthew J. ;

Thompson, Karol L. ;

Vamvakas, Spiros ;

Vidal, Jean-Marc ;

Vonderscher, Jacky ;

Walker, Elizabeth ;

Webb, Craig ;

Yu, Yan .

NATURE BIOTECHNOLOGY, 2010, 28 (05) :446-454

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