The evolution of nonclinical regulatory science: Advanced therapy medicinal products as a paradigm

Molecular Therapy

Volumn 21, Issue 9, 2013, Pages 1644-1648

  Vestergaard, Henrik Tang ^a,b   Apote, Lucia D' ^b   Schneider, Christian K ^a,b,c   Herberts, Carla ^b,d  

^a Danish Health and Medicines Authority   (Denmark)

^b EUROPEAN MEDICINES AGENCY   (United Kingdom)

^c INSTITUTE OF INFECTION IMMUNOLOGY   (Germany)

^d MEDICINES EVALUATION BOARD   (Netherlands)

Author keywords

[No Author keywords available]

Indexed keywords

ADVANCED THERAPY MEDICINAL PRODUCT; GENE THERAPY MEDICINAL PRODUCT; MOLECULAR THERAPY AGENT; SOMATIC CELL THERAPY MEDICINAL PRODUCT; TISSUE ENGINEERED PRODUCT; UNCLASSIFIED DRUG;

DISEASE MODEL; DRUG CONTROL; DRUG DISTRIBUTION; DRUG LEGISLATION; GENOTOXICITY; GOOD LABORATORY PRACTICE; GOOD MANUFACTURING PRACTICE; HEALTH CARE ORGANIZATION; HEALTH HAZARD; HUMAN; MEDICAL DEVICE; NONHUMAN; NOTE; PATIENT SAFETY; RISK ASSESSMENT; RISK MANAGEMENT; SOMATIC CELL THERAPY; SPECIES DIFFERENCE; TISSUE SPECIFICITY; TOXICITY TESTING; TRANSGENIC ORGANISM; TRANSLATIONAL RESEARCH;

ADVISORY COMMITTEES; ANIMALS; BIOLOGICAL THERAPY; CELL- AND TISSUE-BASED THERAPY; CONSUMER PRODUCT SAFETY; GENETIC THERAPY; GUIDELINES AS TOPIC; HUMANS; THERAPIES, INVESTIGATIONAL; TISSUE ENGINEERING; TOXICITY TESTS;

EID: 84883685631     PISSN: 15250016     EISSN: 15250024     Source Type: Journal    
DOI: 10.1038/mt.2013.175     Document Type: Note

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