Nonclinical aspects of biopharmaceutical development: Discussion of case studies at a PhRMA-FDA workshop

International Journal of Toxicology

Volumn 27, Issue 4, 2008, Pages 303-312

  Buckley, L A ^a   Benson, K ^b   Davis Bruno, K ^b   Dempster, M ^c   Finch, G L ^d   Harlow, P ^b   Haggerty, H G ^e   Hart, T ^f   Kinter, L ^g   Leighton, J K ^b   McNulty, J ^g   Roskos, L ^h   Saber, H ^b   Stauber, A ^a   Tabrizi, M ^h  

^a ELI LILLY AND COMPANY   (United States)

^b CENTER FOR DRUG EVALUATION AND RESEARCH   (United States)

^c GLAXOSMITHKLINE   (United Kingdom)

^d PFIZER INC   (United States)

^e BRISTOL MYERS SQUIBB COMPANY   (United States)

^f GLAXOSMITHKLINE   (United States)

^g ASTRAZENECA   (United Kingdom)

^h Medimmune Inc   (United States)

Author keywords

Biopharmaceuticals; Nonclinical; Regulatory; Safety assessment

Indexed keywords

HUSAFE 001; IMMUNOGLOBULIN G1 ANTIBODY; MACROGOL; MUSAFE 001; PROTEIN D1; RECOMBINANT HORMONE; RECOMBINANT PROTEIN; TGN 1412; UNCLASSIFIED DRUG;

ANAPHYLAXIS; APOPTOSIS; ARTICLE; BODY POSTURE; CANCER IMMUNOTHERAPY; CENTRAL NERVOUS SYSTEM DISEASE; DEVELOPMENTAL STAGE; DOSE CALCULATION; DRUG CARCINOGENICITY; DRUG CLEARANCE; DRUG DOSE; DRUG DOSE ESCALATION; DRUG EFFICACY; DRUG LEGISLATION; DRUG MECHANISM; DRUG MEGADOSE; DRUG PROTEIN BINDING; DRUG RESEARCH; DRUG SAFETY; DRUG TARGETING; EMBRYOTOXICITY; EXPERIMENTAL MODEL; GROWTH DISORDER; HEART DISEASE; HUMAN; IMMUNOGENICITY; IMMUNOMODULATION; IMMUNOTOXICITY; IN VITRO STUDY; KIDNEY DISEASE; LEARNING; LETHARGY; MAXIMUM TOLERATED DOSE; MEDICAL LITERATURE; MULTIPLE CYCLE TREATMENT; MUTAGENIC ACTIVITY; NEOPLASM; NEUROTOXICITY; NONHUMAN; ORGANOGENESIS; PRACTICE GUIDELINE; PRIMATE; PROTEINURIA; REPEATED DRUG DOSE; REPRODUCTIVE TOXICITY; RISK BENEFIT ANALYSIS; SCIENCE; SINGLE DRUG DOSE; TOXICOLOGY; TREATMENT DURATION;

ANIMALS; BIOLOGICAL FACTORS; CHEMISTRY, PHARMACEUTICAL; HUMANS; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

PRIMATES;

EID: 53049092892     PISSN: 10915818     EISSN: 1092874X     Source Type: Journal    
DOI: 10.1080/10915810802367016     Document Type: Article

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