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Surrogate endpoint
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31	Microsoft Word - The Pediatric Heart Network - A Primer for the Conduct of Multicenter Studies in Children with Congenital and Add to Reading List Source URL: www.pediatricheartnetwork.org Language: English - Date: 2014-07-08 10:01:14 Medicine Health Medical statistics Design of experiments Clinical trials Surrogate endpoint National Heart Lung and Blood Institute Postherpetic neuralgia Clinical endpoint Clinical research Research Epidemiology
32	Companion Diagnostic Guidance Add to Reading List Source URL: www.fda.gov Language: English Medical research Clinical trials Epidemiology Medical terms Pharmacology Biomarker Surrogate endpoint Validation Food and Drug Administration Medicine Biology Health
33	Topic 1 Pharmacogenetics of Irinotecan: Scientific and Clinical Impact of UGT Polymorphism 1. Is the pharmacokinetic and clinical evidence presented sufficient to demonstrate that homozygous UGT1A128 genotypes (7/7 ge Add to Reading List Source URL: www.fda.gov Language: English* - Date: 2004-10-14 14:44:52 Clinical trials Epidemiology Medical research Medical terms Prodrugs Biomarker Irinotecan Surrogate endpoint CYP3A4 Medicine Chemistry Health
34	V. QUESTIONS FOR THE PANEL In addressing the following premarket questions, please keep in mind that the ultimate goal of these studies is to collect sufficient premarket clinical data Add to Reading List Source URL: www.fda.gov Language: English Medical statistics Prostate cancer End point of clinical trials Prostate Surrogate endpoint Cancer Prostate cancer screening Prostate-specific antigen Medicine Health Clinical trials
35	Topic 1 Pharmacogenetics of Irinotecan: Scientific and Clinical Impact of UGT Polymorphism 1. Is the pharmacokinetic and clinical evidence presented sufficient to Add to Reading List Source URL: www.fda.gov Language: English - Date: 2004-10-14 14:44:52 Clinical trials Epidemiology Medical research Medical terms Prodrugs Biomarker Irinotecan Surrogate endpoint CYP3A4 Medicine Chemistry Health
36	MRD as a Surrogate Endpoint for Efficacy Evaluation of New Drugs in Very High Risk ALL: Lessons from Ph+ ALL FDA Meeting; April 18th, 2012 Stephen P. Hunger, M.D. Chair, COG ALL Committee Add to Reading List Source URL: www.fda.gov Language: English Minimal residual disease Imatinib Chemotherapy Medicine Piperazines Philadelphia chromosome
37	Gastrointestinal Drugs Advisory Committee Meeting NSAID-Associated Gastric and/or Duodenal Ulcers as Endpoints to Support Product Labeling November 4, 2010 Add to Reading List Source URL: www.fda.gov Language: English Clinical research FDA Fast Track Development Program Surrogate endpoint Center for Drug Evaluation and Research Imaging biomarker Food and Drug Administration Medicine Health
38	Microsoft Word - Final Agenda for MRD workshop April[removed]doc Add to Reading List Source URL: www.fda.gov Language: English Leukemia Minimal residual disease Clinical trials Medical research Medical terms Acute lymphoblastic leukemia Surrogate endpoint Biomarker Personalized medicine Medicine Health Pharmacology
39	FDA ASK Children’s Workshop September 2010 Neil Friedman, MBChB Neurological Institute Cleveland Clinic Add to Reading List Source URL: www.fda.gov Language: English Medical specialties Clinical pharmacology Food and Drug Administration Pharmacology United States Public Health Service Physical therapy Pediatrics Surrogate endpoint Medicine Health Medical terms
40	WHITE PAPER ESTABLISHING THE STANDARDS IN BIOMARKER RESEARCH. Add to Reading List Source URL: thomsonreuters.com Language: English - Date: 2014-09-23 16:58:05 Medical research Clinical trials Epidemiology Medical terms Pharmacology Biomarker Imaging biomarker Surrogate endpoint Personalized medicine Medicine Biology Health

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