Monoclonal antibodies - Regulatory challenges

Current Pharmaceutical Biotechnology

Volumn 9, Issue 6, 2008, Pages 431-438

  Schneider, Christian K ^a  

^a PAUL EHRLICH INSTITUT   (Germany)

Author keywords

Clinical development; CMC; Drug development; Monoclonal antibodies; Non clinical development; Regulatory agencies; Relevant species; Risk management

Indexed keywords

ABCIXIMAB; ADALIMUMAB; ALEMTUZUMAB; BASILIXIMAB; BEVACIZUMAB; CETUXIMAB; DACLIZUMAB; ECULIZUMAB; EFALIZUMAB; INFLIXIMAB; INTERLEUKIN 2; INTERLEUKIN 2 RECEPTOR; MONOCLONAL ANTIBODY; MONOCLONAL ANTIBODY CD3; NATALIZUMAB; PANITUMUMAB; RITUXIMAB; SULESOMAB; TGN 1412; TRASTUZUMAB; VASCULOTROPIN;

AMINO ACID SEQUENCE; ANTIBODY DEPENDENT CELLULAR CYTOTOXICITY; BIOTECHNOLOGY; CELL MEDIATED CYTOTOXICITY; CLINICAL TRIAL; CROHN DISEASE; DRUG EFFICACY; DRUG HALF LIFE; DRUG MANUFACTURE; DRUG MECHANISM; DRUG QUALITY; DRUG SAFETY; DRUG SURVEILLANCE PROGRAM; DRUG TARGETING; ENZYME LINKED IMMUNOSORBENT ASSAY; EUROPE; EXPERIMENTAL MODEL; GLYCOSYLATION; GOOD MANUFACTURING PRACTICE; HUMAN; INHIBITION KINETICS; LICENCE; MULTIPLE SCLEROSIS; NONHUMAN; PAROXYSMAL NOCTURNAL HEMOGLOBINURIA; PATIENT SAFETY; PRACTICE GUIDELINE; PROGRESSIVE MULTIFOCAL LEUKOENCEPHALOPATHY; QUALITY CONTROL; RESPIRATORY SYNCYTIAL PNEUMOVIRUS; REVIEW; RISK ASSESSMENT; RISK MANAGEMENT; SHOCK; SPECIES DIFFERENCE; T LYMPHOCYTE ACTIVATION; UNSTABLE ANGINA PECTORIS;

ANTIBODIES, MONOCLONAL; CLINICAL TRIALS AS TOPIC; DRUG APPROVAL; DRUG INDUSTRY; GOVERNMENT REGULATION; INTERNATIONALITY;

MURINAE;

EID: 60849118407     PISSN: 13892010     EISSN: 18734316     Source Type: Journal    
DOI: 10.2174/138920108786786394     Document Type: Review

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