Particle engineering: a strategy for establishing drug substance physical property specifications during small molecule development.

Abstract

A strategy for physical property control of a drug substance has been developed that utilizes a science-based approach to define key drivers for particle control. These drivers are based on in vivo performance (or expected performance), content uniformity of the drug substance in drug product, and manufacturability of drug product. Quality by design… (More)
DOI: 10.1002/jps.21801

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Cite this paper

@article{Iacocca2010ParticleEA, title={Particle engineering: a strategy for establishing drug substance physical property specifications during small molecule development.}, author={Ronald G. Iacocca and Christopher L Burcham and Lori R Hilden}, journal={Journal of pharmaceutical sciences}, year={2010}, volume={99 1}, pages={51-75} }