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October 02, 2019
Research into peginterferon alfa-2b’s degradation pathways suggest that drug substance be immediately and continuously converted to drug product when the material is in liquid form.
September 02, 2019
Research compared the properties of corticosteroids processed by wet and dry milling for use in inhalation formulations.
July 02, 2019
To rapidly achieve high-quality pharmaceutical manufacturing processes, industry must develop prospective, management-based approaches instead of retrospective performance-based measures.
June 02, 2019
Protecting the integrity of raw data is crucial to regulatory compliance and to proving that manufacturing and quality operations are being run and managed properly.
May 02, 2019
In Karl Fischer analysis, sulfur trioxide can react with DMSO, invalidating test results. The authors evaluated different instruments and methods, described in this article, to minimize the impact on results.
April 02, 2019
It is important to address manufacturing problems associated with the shorter shelf-life of pegylated L-asparaginase (pegaspargase) upon long-term storage in the form of a solution.
March 02, 2019
Optical coherence tomography can improve quality control and development of coated dosage forms by allowing film thickness to be measured in real time.
November 02, 2018
This paper describes how the concept of acceptance value can be redefined to remove bias and more closely reflect quality targets.
October 02, 2018
Internal release limits help ensure that a batch of drug product remains within specifications throughout its shelf life. This article explores what internal release limits are and why they are important.
September 02, 2018
This article focuses on applying new and traditional techniques to design a cleaning process, ensure the surfaces are clean, and develop rinse solution analysis to continuously monitor cleaning performance.