Clinical pharmacology as a cornerstone of orphan drug development

Nature Reviews Drug Discovery

Volumn 10, Issue 11, 2011, Pages 795-796

  Bashaw, Edward D ^a   Huang, Shiew Mei ^a   Coté, Timothy R ^b,c   Pariser, Anne R ^a   Garnett, Christine E ^a   Burckart, Gilbert ^a   Zhang, Lei ^a   Men, Angela Y ^a   Le, Christine D ^a   Charlab, Rosane ^a   Gobburu, Jogaro V ^a   Lesko, Lawrence J ^d  

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

^b National Organization for Rare Disorders   (United States)

^c KECK GRADUATE INSTITUTE   (United States)

^d UNIVERSITY OF FLORIDA   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

CARGLUMIC ACID; ERLOTINIB; GEMCITABINE; MIDAZOLAM; ORPHAN DRUG; RITONAVIR; SILDENAFIL; TETRABENAZINE; VANDETANIB;

AREA UNDER THE CURVE; DOSE RESPONSE; DRUG APPROVAL; DRUG COMPETITION; DRUG CONTROL; DRUG DOSE REDUCTION; DRUG EFFICACY; DRUG INDUSTRY; DRUG METABOLISM; DRUG RESEARCH; DRUG SAFETY; FOOD AND DRUG ADMINISTRATION; HUMAN; HUNTINGTON CHOREA; LUNG NON SMALL CELL CANCER; NAGS DEFICIENCY; PANCREAS CANCER; PRIORITY JOURNAL; QUANTITATIVE ANALYSIS; REVIEW; RISK BENEFIT ANALYSIS; THYROID MEDULLARY CARCINOMA;

ANIMALS; DRUG DISCOVERY; HUMANS; ORPHAN DRUG PRODUCTION; PHARMACOLOGY, CLINICAL; RARE DISEASES; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 80155150400     PISSN: 14741776     EISSN: 14741784     Source Type: Journal    
DOI: 10.1038/nrd3595     Document Type: Review

References (6)

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