Quantitative Analysis to Guide Orphan Drug Development | Zendy

Lesko L J | Zendy

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Quantitative Analysis to Guide Orphan Drug Development

Author(s) -

Lesko L J

Publication year - 2012

Publication title -

clinical pharmacology and therapeutics

Language(s) - English

Resource type - Journals

SCImago Journal Rank - 1.941

H-Index - 188

eISSN - 1532-6535

pISSN - 0009-9236

DOI - 10.1038/clpt.2012.80

Subject(s) - orphan drug , clinical pharmacology , drug development , pharmacology , drug , medicine , bioinformatics , biology

The development of orphan drugs for rare diseases has made impressive strides in the past 10 years. There has been a surge in orphan drug designations, but new drug approvals have not kept up. This article presents a three‐pronged hierarchical strategy for quantitative analysis of data at the descriptive, mechanistic, and systems levels of the biological system that could represent a standardized and rational approach to orphan drug development. Examples are provided to illustrate the concept. Clinical Pharmacology & Therapeutics (2012); 92 2, 258–261. doi: 10.1038/clpt.2012.80

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