David Schoneker

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David Schoneker is president, Black Diamond Regulatory Consulting, LLC

Articles

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Understanding Excipient Characteristics to Ensure Robust Continuous Manufacturing

Krizia M. Karry;Brian Carlin;Nigel Langley;R. Christian Moreton;David Schoneker;Katherine L. Ulman;Joseph Zeleznik
June 13th 2024

Key information is needed for excipients and their potential impact on continuous manufacturing processes.

Mitigating the Risk from Excipient Variability

Mitigating the Risk from Excipient Variability

Brian Carlin;George Collins;R. Christian Moreton;David Schoneker;Jennifer Putnam;Joseph Zeleznik;Katherine Ulman;Stacey Bremer
August 3rd 2022

This article reviews sources of excipient variability, including raw materials and processing, both of which may vary from supplier to supplier and from plant to plant for a single manufacturer.

Understanding Concomitant Components in Pharmaceutical Excipients. Image: monsitj - stock.adobe.com

Understanding Concomitant Components in Pharmaceutical Excipients

Jennifer Putnam;Katherine L. Ullman;Priscilla Zawislak;David Schoneker;George Collins;Douglas G. Muse;Brian Carlin;Joseph Zeleznik;R. Christian Moreton
February 3rd 2021

Viewpoint: Continued dialogue among pharma stakeholders is needed to achieve consensus regarding excipient composition.

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