Managing Biomarker Outsourcing: CRO Evaluation, Streamline Outsource Process, and Quality Management

作者: Jeffrey A. Tsou

DOI: 10.1007/978-3-319-40793-7_17

关键词:

摘要: For the past decade pharmaceutical industry has faced numerous challenges, such as rising cost of RD assessment and selection CRO, application strategic partnered relationship outsourcing model, trust execution. Completion successful will establish a that can be fruitful rewarding for future projects help support an innovative drug development process.

参考文章(11)
Janet Jones, Michael Minor, New, strategic outsourcing models to meet changing clinical development needs. Perspectives in Clinical Research. ,vol. 1, pp. 76- 79 ,(2010)
Lorna Ewart, David J. Gallacher, Gary Gintant, Jean-Michel Guillon, Derek Leishman, Paul Levesque, Nick McMahon, Lou Mylecraine, Martin Sanders, Willi Suter, Rob Wallis, Jean-Pierre Valentin, How do the top 12 pharmaceutical companies operate safety pharmacology Journal of Pharmacological and Toxicological Methods. ,vol. 66, pp. 66- 70 ,(2012) , 10.1016/J.VASCN.2012.03.004
Lieven Meerpoel, Marc Schroven, Koen Goris, Koen Demoen, Siobhan Marsden, Outsourcing to exploit a key asset. Drug Discovery Today. ,vol. 11, pp. 556- 560 ,(2006) , 10.1016/J.DRUDIS.2006.04.015
Graeme M Robertson, Lorenz M Mayr, Collaboration versus outsourcing: the need to think outside the box. Future Medicinal Chemistry. ,vol. 3, pp. 1995- 2020 ,(2011) , 10.4155/FMC.11.160
Devon L. Ramsay, Joseph D. Kwasnoski, Gary W. Caldwell, Small Molecule Compound Logistics Outsourcing – Going Beyond the “Thought Experiment” Current Topics in Medicinal Chemistry. ,vol. 12, pp. 1298- 1308 ,(2012) , 10.2174/156802612800672826
David E. Clark, Outsourcing lead optimization: the eye of the storm Drug Discovery Today. ,vol. 16, pp. 147- 157 ,(2011) , 10.1016/J.DRUDIS.2010.11.012
Thomas G. Klopack, Balancing the risks and the benefits Drug Discovery Today. ,vol. 5, pp. 157- 160 ,(2000) , 10.1016/S1359-6446(00)01469-0
K I Kaitin, J A DiMasi, Pharmaceutical Innovation in the 21st Century: New Drug Approvals in the First Decade, 2000–2009 Clinical Pharmacology & Therapeutics. ,vol. 89, pp. 183- 188 ,(2011) , 10.1038/CLPT.2010.286
Jean W Lee, Viswanath Devanarayan, Yu Chen Barrett, Russell Weiner, John Allinson, Scott Fountain, Stephen Keller, Ira Weinryb, Marie Green, Larry Duan, James A Rogers, Robert Millham, Peter J O'brien, Jeff Sailstad, Masood Khan, Chad Ray, John A Wagner, None, Fit-for-Purpose Method Development and Validation for Successful Biomarker Measurement Pharmaceutical Research. ,vol. 23, pp. 312- 328 ,(2006) , 10.1007/S11095-005-9045-3