The
View from Here
Janet Woodcock, M.D.
The U.S. Food and Drug Administration unveiled the Critical Path Initiative with the intent of using scientific advances, such as genomics and advanced imaging technologies, to modernize drug development...
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Upcoming Issues
April 2008
Disease Models
May 2008
Translational Drug Discovery
June 2008
Text Mining
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A
review of 2006
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Top
Reviews |
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Blood safety: opportunities and challenges addressed through Critical Path research at FDA
Atreya CD and Epstein JS
Drug Discovery Today: Technologies
New scientific discoveries and technologies create
opportunities for medical and public health advancement
through development of innovative products.
However, novel products and technologies bring new
challenges to regulation...
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The pharmacology of electrical stimulation in the heart: where devices meet drugs
Krauthamer V
Drug Discovery Today: Technologies
Both cardiac electrical stimulation and cardiac pharmacological
agents exert effects by acting upon ion
channels, secondary messengers and autonomic nerve
terminals. Defining the common substrates between
devices and drugs provides...
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Metabolomic biomarkers: their role in the Critical Path
Schnackenberg LK and Beger RD
Drug Discovery Today: Technologies
Global metabolic profiling is being applied to identify
biomarkers of health. Some small molecules are exquisitely
sensitive indicators of health status. Metabolic
profiling analyses are being used to determine biomarkers
of drug safety and effectiveness as well as disease
diagnosis and prognosis...
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Assessment of visual performance in the evaluation of new medical products
Drum B, Calogero D and Rorer E
Drug Discovery Today: Technologies
When evaluating how a medical product affects vision,
it is important to assess how that product affects the
ability to function in real life, not only the ability to read
letters on a vision chart. Nevertheless, the measurement
of visual acuity with a vision chart remains the
primary test of the effects...
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Abstracts
of Key Research Articles
The FDA critical path initiative and its influence on new drug development
Woodcock J and Woosley R
Annu Rev Med. 2008; 59; 1–12
The prospects for "personalized medicine" in drug development and drug therapy
Woodcock J
Clin Pharmacol Ther. 2007; 81; 164–169
Paving the critical path: how can clinical pharmacology help achieve the vision?
Lesko LJ
Clin Pharmacol Ther. 2007; 81; 170–177
A prototypical process for creating evidentiary standards for biomarkers and diagnostics
Altar CA, Amakye D, Bounos D, Bloom J, Clack G, Dean R, Devanarayan V, Fu D, Furlong S, Hinman L, Girman C, Lathia C, Lesko L, Madani S, Mayne J, Meyer J, Raunig D, Sager P, Williams SA, Wong P and Zerba K
Clin Pharmacol Ther. 2008; 83; 368–371
Innovative early development regulatory approaches: expIND, expCTA, microdosing
Robinson WT
Clin Pharmacol Ther. 2008; 83; 358–360
Drug development and the FDA's Critical Path Initiative
Woosley RL and Cossman J
Clin Pharmacol Ther. 2007; 81; 129–133
Promises of biomarkers in drug development–a reality check
Marrer E and Dieterle F
Chem Biol Drug Des. 2007; 69; 381–394
Search for shortcuts on the critical path to market: US FDA perspectives from the diagnostic side
Gutman S and Hackett J
Pharmacogenomics 2006; 7; 1223–1227
FDA's Critical Path Initiative: a perspective on contributions of biostatistics
O’Neill RT
Biom J. 2006; 48; 559–564
Clinical utility of the Food and Drug Administration Electrocardiogram Warehouse: a paradigm for the Critical Pathway Initiative
Cabell CH, Noto TC and Krucoff MW
J Electrocardiol. 2005; 38(4 Suppl); 175–179
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