Legal and Scientific Considerations in Nonclinical Assessment of Biotechnology Products

Drug Information Journal

Volumn 37, Issue 4, 2003, Pages 397-406

  Tsang, Lincoln ^a   Beers, Donald ^b  

^a Arnold and Porter   (United Kingdom)

^b Arnold and Porter   (United States)

Author keywords

Biotechnology products; Legal and scientific aspects; Nonclinical testing

Indexed keywords

ANTIANEMIC AGENT; ANTICOAGULANT AGENT; BIOLOGICAL PRODUCT; BLOOD DERIVATIVE; DNA VACCINE; MONOCLONAL ANTIBODY; NUCLEIC ACID; RECOMBINANT ANTIBODY; RECOMBINANT CYTOKINE; RECOMBINANT ENZYME; RECOMBINANT GROWTH FACTOR; RECOMBINANT HORMONE; RECOMBINANT HUMAN INSULIN; RECOMBINANT INTERFERON; RECOMBINANT PROTEIN; RECOMBINANT TUMOR NECROSIS FACTOR; SMALLPOX VACCINE; TRIPLE VACCINE; TUMOR NECROSIS FACTOR ANTIBODY; VACCINE; VACCINIA VACCINE;

ALLOGRAFT; BIOTECHNOLOGICAL PRODUCTION; CELL BASED GENE THERAPY; DRUG APPROVAL; DRUG DESIGN; DRUG EFFICACY; DRUG MANUFACTURE; DRUG SAFETY; DRUG SCREENING; EUROPEAN UNION; EVALUATION; FOOD AND DRUG ADMINISTRATION; GENE THERAPY; LAW; PRACTICE GUIDELINE; PRIORITY JOURNAL; QUALITY CONTROL; REVIEW; RISK MANAGEMENT; SAFETY; UNITED STATES;

EID: 0344395047     PISSN: 00928615     EISSN: None     Source Type: Journal    
DOI: 10.1177/009286150303700406     Document Type: Review

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