A Risk-Based Approach to Management of Leachables Utilizing Statistical Analysis of Extractables

Abstract

To incorporate quality by design concepts into the management of leachables, an emphasis is often put on understanding the extractable profile for the materials of construction for manufacturing disposables, container-closure, or delivery systems. Component manufacturing processes may also impact the extractable profile. An approach was developed to (1… (More)
DOI: 10.1208/s12249-014-0221-9

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Cite this paper

@article{Stults2014ARA, title={A Risk-Based Approach to Management of Leachables Utilizing Statistical Analysis of Extractables}, author={Cheryl L. M. Stults and Jaromir Mikl and Oliver Whelehan and Bradley D Morrical and William Duffield and Lee M. Nagao}, journal={AAPS PharmSciTech}, year={2014}, volume={16}, pages={315-326} }