Comparative requirements for exploratory clinical trials - eIND, eCTA and microdosing

Advanced Drug Delivery Reviews

Volumn 63, Issue 7, 2011, Pages 511-517

  Muller, Patrick Y ^a  

^a NOVARTIS INSTITUTES FOR BIOMEDICAL RESEARCH   (United States)

Author keywords

Clinical trial; ECTA; EIND; Exploratory; First in human; Microdosing; Safety assessment; Toxicity study; Toxicology; Translational medicine

Indexed keywords

CLINICAL TRIAL; ECTA; EIND; EXPLORATORY; FIRST-IN-HUMAN; MICRODOSING; SAFETY ASSESSMENT; TOXICOLOGY; TRANSLATIONAL MEDICINE;

MEDICAL APPLICATIONS; MEDICINE; MONOCLONAL ANTIBODIES; TOXICITY;

EXPERIMENTS;

BIOLOGICAL MARKER; FOLIC ACID ANTAGONIST; MITOGEN ACTIVATED PROTEIN KINASE P38 INHIBITOR; MONOCLONAL ANTIBODY; NONSTEROID ANTIINFLAMMATORY AGENT; PHOSPHODIESTERASE IV INHIBITOR;

AREA UNDER THE CURVE; BIOTECHNOLOGY; CLINICAL TRIAL (TOPIC); COMPARATIVE STUDY; DOSIMETRY; DRUG ELIMINATION; DRUG EXPOSURE; DRUG METABOLISM; DRUG MICRODOSE; DRUG RESEARCH; DRUG SAFETY; DRUG TARGETING; DRUG TOLERABILITY; EXPLORATORY RESEARCH; FIRST PASS EFFECT; FOOD AND DRUG ADMINISTRATION; GENOTOXICITY; GOOD MANUFACTURING PRACTICE; HUMAN; MAXIMUM PLASMA CONCENTRATION; MAXIMUM TOLERATED DOSE; MUTAGENICITY; NONHUMAN; PHARMACODYNAMICS; PHARMACOKINETICS; PRACTICE GUIDELINE; PRIORITY JOURNAL; RESEARCH SUBJECT; REVIEW; STANDARDIZATION;

ANIMALS; ANTIBODIES, MONOCLONAL; BIOTECHNOLOGY; CLINICAL TRIALS AS TOPIC; CLINICAL TRIALS, PHASE I AS TOPIC; DOSE-RESPONSE RELATIONSHIP, DRUG; DRUGS, INVESTIGATIONAL; GUIDELINES AS TOPIC; HUMANS; INTERNATIONAL COOPERATION; MODELS, BIOLOGICAL;

EID: 79957782002     PISSN: 0169409X     EISSN: 0169409X     Source Type: Journal    
DOI: 10.1016/j.addr.2010.10.010     Document Type: Review

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