Understanding and applying regulatory guidance on the nonclinical development of biotechnology-derived pharmaceuticals

BioDrugs

Volumn 20, Issue 1, 2006, Pages 25-52

  Snodin, David J ^a   Ryle, Peter R ^b  

^a PAREXEL INTERNATIONAL   (United States)

^b PR BioServices Ltd   (United Kingdom)

Author keywords

[No Author keywords available]

Indexed keywords

APDIRA; BLOOD CLOTTING FACTOR 9 CONCENTRATE; CALCITONIN; DESULFATOHIRUDIN; DROTRECOGIN; FORCALCITONIN; GANIRELIX; HUMAN GROWTH HORMONE; INSULIN ASPART; INSULIN DETEMIR; INSULIN GLARGINE; INSULIN GLULISINE; INSULIN LISPRO; INSULIN ZINC SUSPENSION; ISOPHANE INSULIN; LARONIDASE; LEPIRUDIN; NEUTRAL INSULIN; PARATHYROID HORMONE[1-34]; PEGVISOMANT; PROTEIN C; RECOMBINANT BLOOD CLOTTING FACTOR 7A; RECOMBINANT BLOOD CLOTTING FACTOR 8; RECOMBINANT BLOOD CLOTTING FACTOR 9; RECOMBINANT CHORIONIC GONADOTROPIN; RECOMBINANT FOLLITROPIN; RECOMBINANT HUMAN INSULIN; RECOMBINANT LUTEINIZING HORMONE; RECOMBINANT THYROTROPIN; RETEPLASE; TENECTEPLASE; UNINDEXED DRUG;

BIOTECHNOLOGY; DRUG LABELING; DRUG MARKETING; DRUG SAFETY; FOOD AND DRUG ADMINISTRATION; GENE THERAPY; GOOD MANUFACTURING PRACTICE; HUMAN; NONHUMAN; PRACTICE GUIDELINE; PRIORITY JOURNAL; REVIEW; TISSUE ENGINEERING; WORLD HEALTH ORGANIZATION;

ANIMALS; BIOLOGICAL PRODUCTS; BIOTECHNOLOGY; CLINICAL TRIALS; DRUG APPROVAL; DRUG EVALUATION, PRECLINICAL; EUROPEAN UNION; GUIDELINES; HUMANS; INTERNATIONAL COOPERATION; PHARMACEUTICAL PREPARATIONS; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION; WORLD HEALTH ORGANIZATION;

EID: 33645540499     PISSN: 11738804     EISSN: 11738804     Source Type: Journal    
DOI: 10.2165/00063030-200620010-00003     Document Type: Review

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