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Clinical endpoint
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61	U.S. Food and Drug Administration Notice: Archived Document The content in this document is provided on the FDA’s website for reference purposes only. It was current when produced, but is no longer maintained and may Add to Reading List Source URL: www.fda.gov Language: English Medical statistics Health Epidemiology Medical research Surrogate endpoint End point of clinical trials Progression-free survival Ovarian cancer FDA Fast Track Development Program Medicine Clinical trials Medical terms
62	U.S. Food and Drug Administration Notice: Archived Document The content in this document is provided on the FDA’s website for reference purposes only. It was current when produced, but is no longer maintained and may Add to Reading List Source URL: www.fda.gov Language: English Health Clinical trials Medical research Medical terms Surrogate endpoint Clinical endpoint Biomarker Ovarian cancer Hazard ratio Medicine Epidemiology Medical statistics
63	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
64	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
65	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
66	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
67	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
68	Microsoft PowerPoint - Session V_EnrichmentCAMDAnnualMeeting12Nov2013-2 [Compatibility Mode] Add to Reading List Source URL: c-path.org Language: English - Date: 2014-02-20 17:49:57 Breast cancer Tamoxifen Prostatectomy MammaPrint Prognosis Clinical endpoint Management of prostate cancer Medicine Surgical oncology Prostate cancer
69	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
70	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

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