Articles by Tim Schofield - Pharmaceutical Technology

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Articles by Tim Schofield

Tim Schofield


Tim Schofield is senior director, nonclinical statistics, at Merck Research Laboratories.

Articles
Overcoming Disincentives to Process Understanding in the Pharmaceutical CMC Environment
September 2, 2007

Larger and strategic sampling and testing plans can improve process understanding and characterization.

Revisiting The Notion Of Singlet Testing Requirements
June 2, 2005

In his Feb. 2005 viewpoint article, "In Defense of Singlet Testing," Torbeck (1) draws an important philosophical distinction between "standards" and "specifications." He argues that specifications are criteria selected by manufacturers for statistical control of their products, whereas compendial standards are absolute requirements. This distinction is entirely compatible with modern concepts of statistical process control.

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Eric Langerr Outsourcing Outlook Eric LangerTargeting Different Off-Shore Destinations
Cynthia Challener, PhD Ingredients Insider Cynthia ChallenerAsymmetric Synthesis Continues to Advance
Jill Wechsler Regulatory Watch Jill Wechsler Data Integrity Key to GMP Compliance
Sean Milmo European Regulatory WatchSean MilmoExtending the Scope of Pharmacovigilance Comes at a Price
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