Document Detail

Regulatory affairs issues and legal ontologies in drug development .
MedLine Citation:
PMID:  23277001     Owner:  NLM     Status:  In-Data-Review    
It usually can take more than ten years from the time a new drug is discovered, until can be launched on the market. Regulatory requirements are part of the process of drug discovery and drug development. It acts at every developmental stage. Regulatory affairs works to establish an effective and uniform balance between voluntary and regulatory compliance and agency responsiveness to consumer needs. It evaluates and coordinates all proposed legal actions to ascertain compliance with regulatory policy. The ontology presented for regulatory affairs and drug research and development gives us the possibility to correlate information from different levels and to discover new relationships between the legal aspects. In addition, the transparency of the information is affected by the inability of existing integration strategies to organize and apply the available knowledge to the range of real scientific and business issue in critical safety and regulatory applications. Therefore, the semantic technologies based on ontologies make the knowledge reusable by several applications across business, from discovery to corporate affairs.
Cristian Robert Munteanu; Julian Dorado; Ion Matei-Ilfoveanu; Silvia Ana Nita
Publication Detail:
Type:  Journal Article     Date:  2013-01-01
Journal Detail:
Title:  Frontiers in bioscience (Elite edition)     Volume:  5     ISSN:  1945-0508     ISO Abbreviation:  Front Biosci (Elite Ed)     Publication Date:  2013  
Date Detail:
Created Date:  2013-01-01     Completed Date:  -     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  101485240     Medline TA:  Front Biosci (Elite Ed)     Country:  United States    
Other Details:
Languages:  eng     Pagination:  446-60     Citation Subset:  IM    
Department of Information and Communication Technologies, Computer Science Faculty, University of A Coruna, Campus de Elvina, S/N, 15071 A Coruna, Spain.
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