Preclinical pharmacokinetics, biodistribution, radiation dosimetry and acute toxicity studies required for regulatory approval of a Clinical Trial Application for a Phase I/II clinical trial of 111In-BzDTPA-pertuzumab

Nuclear Medicine and Biology

Volumn 42, Issue 2, 2015, Pages 78-84

  Lam, Karen ^a   Chan, Conrad ^a   Done, Susan J ^b,c   Levine, Mark N ^d   Reilly, Raymond M ^a,b,e  

^a UNIVERSITY OF TORONTO   (Canada)

^b UNIVERSITY OF TORONTO   (Canada)

^c PRINCESS MARGARET HOSPITAL   (Canada)

^d MCMASTER UNIVERSITY   (Canada)

^e UNIVERSITY HEALTH NETWORK   (Canada)

Author keywords

Clinical trial application; Indium 111; Pertuzumab; Pharmacokinetics; Radiation dosimetry; Toxicology

Indexed keywords

ALANINE AMINOTRANSFERASE; CREATININE; HEMOGLOBIN; PERTUZUMAB PENTETATE INDIUM; PERTUZUMAB PENTETATE INDIUM IN 111; RADIOPHARMACEUTICAL AGENT; SODIUM CHLORIDE; UNCLASSIFIED DRUG; INDIUM; MONOCLONAL ANTIBODY; PENTETIC ACID; PERTUZUMAB;

ACUTE TOXICITY; ALANINE AMINOTRANSFERASE BLOOD LEVEL; ANIMAL EXPERIMENT; ANIMAL TISSUE; AREA UNDER THE CURVE; ARTICLE; AUTOPSY; BLOOD CELL COUNT; BODY MASS; COMPUTER PROGRAM; CONTROLLED STUDY; CREATININE BLOOD LEVEL; DOSIMETRY; DRUG APPROVAL; DRUG DISTRIBUTION; DRUG ELIMINATION; DRUG HALF LIFE; DRUG SAFETY; FEMALE; FIRST IN HUMAN STUDY; HEMATOCRIT; HEMOGLOBIN BLOOD LEVEL; HISTOPATHOLOGY; IMAGING SOFTWARE; MOUSE; NONHUMAN; PHASE 1 CLINICAL TRIAL (TOPIC); PHASE 2 CLINICAL TRIAL (TOPIC); PREDICTION; RADIATION DOSE; RADIOACTIVITY; WEIGHT REDUCTION; ANIMAL; CHEMISTRY; DIAGNOSTIC USE; HUMAN; RADIOMETRY; SOCIAL CONTROL; TISSUE DISTRIBUTION;

ANIMALS; ANTIBODIES, MONOCLONAL, HUMANIZED; CLINICAL TRIALS, PHASE I AS TOPIC; CLINICAL TRIALS, PHASE II AS TOPIC; DRUG APPROVAL; FEMALE; HUMANS; INDIUM RADIOISOTOPES; MICE; PENTETIC ACID; RADIOMETRY; RADIOPHARMACEUTICALS; SOCIAL CONTROL, FORMAL; TISSUE DISTRIBUTION;

EID: 84921345108     PISSN: 09698051     EISSN: 18729614     Source Type: Journal    
DOI: 10.1016/j.nucmedbio.2014.09.011     Document Type: Article

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