Model-Based Drug Development: Strengths, Weaknesses, Opportunities, and Threats for Broad Application of Pharmacometrics in Drug Development

Author:

Wetherington Jeffrey D.,Pfister Marc,Banfield Christopher,Stone Julie A.,Krishna Rajesh,Allerheiligen Sandy,Grasela Dennis M.

Publisher

Wiley

Subject

Pharmacology (medical),Pharmacology

Reference22 articles.

1. US Food and Drug Administration. Innovation or Stagnation: Challenge and Opportunity on the Critical Path to New Medical Products http:www.fda.gov.ScienceResearchSpecialTopicsCriticalPathInitiativeCriticalPathOpportunitiesReportsucm077262.htm

2. Editorial: the FDA's Critical Path Initiative: a brief introduction;Coons;Clin Ther,2009

3. How to improve R&D productivity: the pharmaceutical industry's grand challenge;Paul;Nat Rev Drug Discovery,2010

4. The state of innovation in drug development;Kola;Clin Pharmacol Ther,2008

5. An evaluation of the integration of pharmacokinetic and pharmacodynamic principles in clinical drug development: experience within Hoffmann La Roche;Reigner;Clin Pharmacokinet,1998

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