Evolving Global Regulatory Science Through the Voluntary Submission of Data: A 2013 Assessment

Therapeutic Innovation and Regulatory Science

Volumn 48, Issue 2, 2014, Pages 236-245

  Walker, Elizabeth Gribble ^a   Brumfield, Martha ^a   Compton, Carolyn ^b   Woosley, Raymond ^c  

^a CRITICAL PATH INSTITUTE   (United States)

^b ARIZONA STATE UNIVERSITY   (United States)

^c AZCERT Inc and NDA Partners LLC   (United States)

Author keywords

biomarker; critical path initiative; Critical Path Institute; drug development tool; European Medicines Agency; Food and Drug Administration; harmonization; novel methodology; Pharmaceuticals and Medical Devices Agency; qualification; regulatory science

Indexed keywords

BIOLOGICAL MARKER;

ARTICLE; CLINICAL PATHWAY; CONFIDENTIALITY; CONSULTATION; DRUG DEVELOPMENT; FOOD AND DRUG ADMINISTRATION; HUMAN; INFORMATION PROCESSING; MEDICAL RESEARCH; MEDICAL TECHNOLOGY; PATENT; PRIORITY JOURNAL; PRODUCT DEVELOPMENT; REGULATORY SCIENCE; SCIENCE; TRANSLATIONAL RESEARCH;

EID: 84895438216     PISSN: 21684790     EISSN: 21649200     Source Type: Journal    
DOI: 10.1177/2168479013508941     Document Type: Article

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