Quantitative pharmacology
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Quantitative Pharmacology (QP) is an organized approach integrating individuals from different disciplines in a combined effort to develop quantitative models in order to solve specific, complex, and multivariate problems in drug development. QP translates the relationship(s) between disease, drug action, and individual variability into improved patient outcomes by leveraging improved teamwork and collaboration to enable quantitative decision-making processes from early discovery to late-stage development. QP encourages more transparent and objective study designs, as well as more data-driven risk-taking to optimize timelines, analyses, and decision-making, resulting in greater efficiency in the drug development process.
Incorporation of QP methodologies will help:
- gain a better understanding of the mechanism of drug-disease interactions and identify molecular targets with high probability of impacting disease (e.g., use of proteomics and cheminformatics in the development of drug-disease models)
- select the ideal drug candidate in early drug development (e.g., integrated and mechanistic PK/PD models)
- optimize clinical trials through modeling and clinical trial simulations
- identify optimal patients and treatment regimens for particular drugs (e.g., development of Health Outcome models)
References
- Zhang L, Pfister M, Meibohm B. Concepts and Challenges in Quantitative Pharmacology and Model-Based Drug Development. AAPS J. 2008 Nov 12. [Epub ahead of print] PMID: 19003542
- Putnam WS, Li J, Haggstrom J, Ng C, Kadkhodayan-Fischer S, Cheu M, Deniz Y, Lowman H, Fielder P, Visich J, Joshi A, Jumbe NS. Use of quantitative pharmacology in the development of HAE1, a high-affinity anti-IgE monoclonal antibody.AAPS J. 2008 Jun;10(2):425-30. Epub 2008 Aug 7. Review. PMID: 18686041
- Barrett JS, Shi J, Xie HT, Huang XH, Fossler MJ, Sun RY. Globalization of quantitative pharmacology: first international symposium of quantitative pharmacology in drug development and regulation. J Clin Pharmacol. 2008 Jul;48(7):787-92. Epub 2008 May 19. PMID: 18490494
- Barrett JS. The role of quantitative pharmacology in an academic translational research environment. AAPS J. 2008;10(1):9-14. Epub 2008 Feb 5. Review. PMID: 18446501
- Atkinson AJ Jr, Lalonde RL. Introduction of quantitative methods in pharmacology and clinical pharmacology: a historical overview. Clin Pharmacol Ther. 2007 Jul;82(1):3-6. No abstract available. PMID: 17571065
- Holford N, Karlsson MO. Time for quantitative clinical pharmacology: a proposal for a pharmacometrics curriculum. Clin Pharmacol Ther. 2007 Jul;82(1):103-5. Epub 2007 May 9. PMID: 17495873
- Krishna R. Quantitative clinical pharmacology: Making paradigm shifts a reality. J Clin Pharmacol. 2006 Sep;46(9):966-7. No abstract available. PMID: 16920890
- Zhang L, Sinha V, Forgue ST, Callies S, Ni L, Peck R, Allerheiligen SR. Model-based drug development: the road to quantitative pharmacology. J Pharmacokinet Pharmacodyn. 2006 Jun;33(3):369-93. Epub 2006 Jun 13. PMID: 16770528
