Use of biomarkers and surrogate endpoints in drug development and regulatory decision making: Criteria, validation, strategies

Annual Review of Pharmacology and Toxicology

Volumn 41, Issue , 2001, Pages 347-366

  Lesko, L J ^a   Atkinson A J , Jr ^a  

^a CENTER FOR DRUG EVALUATION AND RESEARCH   (United States)

Author keywords

Clinical endpoints; Regulatory review

Indexed keywords

ANTIARRHYTHMIC AGENT; ANTIBIOTIC AGENT; ANTIDIABETIC AGENT; ANTIGLAUCOMA AGENT; ANTIHYPERTENSIVE AGENT; ANTILIPEMIC AGENT; ANTINEOPLASTIC AGENT; ANTIRETROVIRUS AGENT; BIOCHEMICAL MARKER; QUINIDINE;

DRUG APPROVAL; DRUG EFFICACY; DRUG MECHANISM; DRUG SAFETY; DRUG SCREENING; HUMAN; MEDICAL DECISION MAKING; PRIORITY JOURNAL; REVIEW;

ANIMALS; BIOLOGICAL MARKERS; DECISION MAKING; ENDPOINT DETERMINATION; HUMANS; LEGISLATION, DRUG; PHARMACOLOGY; REPRODUCIBILITY OF RESULTS;

EID: 0035037328     PISSN: 03621642     EISSN: None     Source Type: Book Series    
DOI: 10.1146/annurev.pharmtox.41.1.347     Document Type: Review

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