Comparison of Stakeholder Metrics for Traditional and Adaptive Development and Licensing Approaches to Drug Development

Therapeutic Innovation and Regulatory Science

Volumn 47, Issue 4, 2013, Pages 474-483

  Baird, Lynn G ^a   Trusheim, Mark R ^b   Eichler, Hans Georg ^c   Berndt, Ernst R ^b   Hirsch, Gigi ^a  

^a MASSACHUSETTS INSTITUTE OF TECHNOLOGY   (United States)

^b MASSACHUSETTS INSTITUTE OF TECHNOLOGY   (United States)

^c EUROPEAN MEDICINES AGENCY   (United Kingdom)

Author keywords

adaptive licensing; adaptiveness score; clinical development; net present value; regulatory policy; stakeholder metrics

Indexed keywords

FINGOLIMOD; RIMONABANT; VEMURAFENIB;

ALGORITHM; ARTICLE; CASE STUDY; CLINICAL DEVELOPMENT PLAN; DRUG DEVELOPMENT; DRUG INDUSTRY; HUMAN; LICENSING; OUTCOME ASSESSMENT; PRIORITY JOURNAL; PROGRAM DEVELOPMENT;

EID: 84879526187     PISSN: 21684790     EISSN: 21649200     Source Type: Journal    
DOI: 10.1177/2168479013487355     Document Type: Article

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