Safety of phasen I clinical trials with monoclonal antibodies in Germany - The regulatory requirements viewed in the aftermath of the TGN1412 disaster

International Journal of Clinical Pharmacology and Therapeutics

Volumn 45, Issue 1, 2007, Pages 1-9

  Liedert, B ^a   Bassus, S ^a   Schneider, C K ^a   Kalinke, U ^a   Lower J ^a  

^a PAUL EHRLICH INSTITUT   (Germany)

Author keywords

Clinical studies; Clinical trials; First in man; GCP; Monoclonal antibodies; Phase I; Pre clinical studies; Safety; TeGenero; TGN1412

Indexed keywords

ADALIMUMAB; CD20 ANTIBODY; CD3 ANTIBODY; INFLIXIMAB; MONOCLONAL ANTIBODY CD28; NATALIZUMAB; TGN 1412; UNCLASSIFIED DRUG; ANTINEOPLASTIC AGENT; MONOCLONAL ANTIBODY; MONOCLONAL ANTIBODY TGN1412;

ANTINEOPLASTIC ACTIVITY; CARDIOGENIC SHOCK; CENTRAL NERVOUS SYSTEM DISEASE; CHRONIC LYMPHATIC LEUKEMIA; CLINICAL PROTOCOL; CLINICAL STUDY; CLINICAL TRIAL; CROHN DISEASE; CROSS REACTION; CYTOKINE RELEASE; CYTOKINE RELEASE SYNDROME; DOSE CALCULATION; DRUG APPROVAL; DRUG DECOMPOSITION; DRUG DOSE ESCALATION; DRUG PURIFICATION; DRUG SAFETY; DRUG SCREENING; EXPERIMENTAL MODEL; FLU LIKE SYNDROME; GERMANY; HUMAN; IMMUNOGENICITY; IMMUNOTOXICITY; IN VITRO STUDY; LEGAL ASPECT; LEUKOENCEPHALOPATHY; LYMPHOCYTE FUNCTION; MULTIPLE SCLEROSIS; NONHUMAN; PATIENT SAFETY; PRACTICE GUIDELINE; RESEARCH ETHICS; RESPIRATORY TRACT DISEASE; REVIEW; RHEUMATOID ARTHRITIS; RISK ASSESSMENT; SINGLE DRUG DOSE; TRANSGENIC ANIMAL; ANIMAL; DRUG LEGISLATION; DRUG SURVEILLANCE PROGRAM; ETHICS; HUMAN EXPERIMENT; METHODOLOGY; PHASE 1 CLINICAL TRIAL; REFERENCE VALUE; TOXICITY TESTING;

ADVERSE DRUG REACTION REPORTING SYSTEMS; ANIMALS; ANTIBODIES, MONOCLONAL; ANTINEOPLASTIC AGENTS; CLINICAL TRIALS, PHASE I; DRUG APPROVAL; DRUG EVALUATION, PRECLINICAL; ETHICAL REVIEW; GERMANY; GUIDELINES; HUMAN EXPERIMENTATION; HUMANS; LEGISLATION, DRUG; NO-OBSERVED-ADVERSE-EFFECT LEVEL; REFERENCE VALUES; RESEARCH DESIGN; RISK ASSESSMENT; TOXICITY TESTS;

EID: 33847375862     PISSN: 09461965     EISSN: None     Source Type: Journal    
DOI: 10.5414/cpp45001     Document Type: Review

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