The EMEA guideline on first-in-human clinical trials and its impact on pharmaceutical development

Toxicologic Pathology

Volumn 37, Issue 3, 2009, Pages 363-371

  Milton, Mark N ^a,c   Horvath, Christopher J ^b  

^a Tempo Pharmaceuticals   (United States)

^b Taligen Therapeutics   (United States)

^c Process Sciences and Production Novartis Biologics   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

DISEASE MODIFYING ANTIRHEUMATIC DRUG; RHUDEX; TGN 1412; UNCLASSIFIED DRUG; DRUG;

CLINICAL STUDY; CLINICAL TRIAL; DOSE CALCULATION; DRUG EFFICACY; DRUG INDUSTRY; DRUG MECHANISM; DRUG RESEARCH; DRUG SAFETY; DRUG TOLERABILITY; HUMAN; NONHUMAN; PRACTICE GUIDELINE; PRIORITY JOURNAL; REVIEW; RHEUMATOID ARTHRITIS; TOXICOLOGY; ANIMAL; ARTICLE; COHORT ANALYSIS; DRUG APPROVAL; DRUG SCREENING; EUROPE; FOOD AND DRUG ADMINISTRATION; GOVERNMENT; LEGAL ASPECT; METHODOLOGY; ORGANIZATION AND MANAGEMENT; PHARMACOKINETICS; PHARMACOLOGY; STANDARD; UNITED STATES;

ANIMALS; CLINICAL TRIALS AS TOPIC; COHORT STUDIES; DRUG APPROVAL; DRUG EVALUATION, PRECLINICAL; DRUG INDUSTRY; EUROPE; GOVERNMENT AGENCIES; GUIDELINES AS TOPIC; HUMANS; PHARMACEUTICAL PREPARATIONS; PHARMACOKINETICS; PHARMACOLOGY; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 67049107949     PISSN: 01926233     EISSN: 15331601     Source Type: Journal    
DOI: 10.1177/0192623309332997     Document Type: Review

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