Most extractable and leachable (E&L) studies are based on liquid formulations. This article examines options for E&L studies to evaluate leaching from primary packaging into lyophilized drugs.
Steven A. Zdravkovic
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Steven A. Zdravkovic is a senior research scientist at PPD Laboratories, Middleton, WI.
Articles by Steven A. Zdravkovic
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Understanding Leaching from Stoppers into Lyophilized DrugsFebruary 1st 2019
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