Assessing the Quality of Decision Making in the Development and Regulatory Review of Medicines: Identifying Biases and Best Practices

Author:

Bujar Magdalena,Donelan Ronan,McAuslane Neil,Walker Stuart,Salek Sam

Publisher

Springer Science and Business Media LLC

Subject

Pharmacology (medical),Public Health, Environmental and Occupational Health,Pharmacology, Toxicology and Pharmaceutics (miscellaneous)

Reference26 articles.

1. Liberti L, McAuslane N, Patel P, Breckenridge A, Eichler HG, Peterson R. Regulatory review: how do agencies ensure the quality of decision making? Clin Pharmacol Ther. 2013;94:305–308.

2. Pinatti F, Ashby D, Brass E, et al. Structured frameworks to increase the transparency of the assessment of benefits and risks of medicines: current status and possible future directions. Clin Pharmacol Ther. 2015;98:522–533.

3. WHO Technical Report Series, No. 992, Annex 9;World Health Organization,2015

4. Patel P, McAuslane N, Liberti L, Connelly P. Workshop report: Focus on Latin America; Building quality submission and review processes and practices—Overcoming challenges and meeting expectations. Centre for Innovation in Regulatory Science. http://cirsci.org/sites/default/files/CIRS_January_2014_Workshop_Report.pdf. Accessed May 19, 2016.

5. Cook D, Brown D, Alexander R, et al. Lessons learned from the fate of AstraZeneca’s drug pipeline: a five-dimensional framework. Nat Rev Drug Discov. 2014;13:419–431.

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