Peer-Reviewed Research

Oct 02, 2018
Pharmaceutical Technology
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.
Sep 02, 2018
Pharmaceutical Technology
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.
Jul 02, 2018
Pharmaceutical Technology
Macromolecular drugs are typically injected, but oral dosage forms are being developed to improve the treatment of gastrointestinal conditions such as inflammatory bowel disease.
Jun 02, 2018
Pharmaceutical Technology
This paper analyzes the effectiveness of histogram binning for representing particle-sizing measurements with accuracy and precision.
May 02, 2018
Pharmaceutical Technology
The working acceptance limits for acceptance values (AV) are determined using the critical values at, for example, 95% coverage over the corresponding AV distributions. However, validity of such limits needs to be elaborated.
Apr 02, 2018
Pharmaceutical Technology
Research suggests that radiation can have a significant impact on the composition and rheology of hydroxyethyl cellulose-based medicinal gels.
Mar 02, 2018
Pharmaceutical Technology
This article describes a new, combined, quantitative method for assessing excipient risks that has been developed by the authors as one possible risk evaluation method.
Feb 02, 2018
Pharmaceutical Technology
The following study describes a methodology to establish, control, and characterize an aerosolized bioburden within a test chamber and determine the settling rate of the bioburden.
Jan 02, 2018
Pharmaceutical Technology
A new algorithm uses a statistical approach to critical process parameter assessment, allowing for faster, more consistent, and less subjective critical process parameter quantification, visualization, and documentation.
Dec 02, 2017
Pharmaceutical Technology
In Part I of this article series, the authors discussed the regression control chart method for identifying out-of-trend data in pharmaceutical stability studies. In Part II, the by-time-point method and the multivariate control chart method are investigated, and improved approaches are suggested. The method is illustrated using real data sets.
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