Peer-Reviewed Research

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.
Nov 02, 2017
Pharmaceutical Technology
In Part I of this article series, the regression control chart method for identifying out-of-trend data in pharmaceutical stability studies is investigated, and an improved approach is suggested.
Oct 02, 2017
Pharmaceutical Technology
The authors demonstrate that a proper measure of HPMC solution concentration is its electrical conductivity rather than its viscosity.
Sep 02, 2017
Pharmaceutical Technology
This study shows that the presence of API lumps can be detected by inline NIR, and elaborates on why NIR sensor dimensions and actual measured sample volume by the NIR sensor are important variables for adequate interpretation of obtained results.
Aug 02, 2017
Pharmaceutical Technology
The author describes how to establish acceptance limits for acceptance value (AV) data for process validation batches, typical characteristics of AV distributions, and how to derive relevant constants for AV control charts in annual product review and continued process verification reports.
Jul 02, 2017
Pharmaceutical Technology
Incorporating structural constraints into pharmacokinetic studies of iron sucrose formulations.
Jun 02, 2017
Pharmaceutical Technology
In this study, the authors describe a forensic microscopy approach to characterize particles that were visually observed during stressed stability testing of an ophthalmic solution formulation.
May 02, 2017
Pharmaceutical Technology
In this study, the authors investigated the relationship between the 0.001 MinDD and the PDE values for 140 drug substances as an attempt to identify high-risk groups of products for patient safety. This comparison can serve as a method for prioritization of APIs for development of PDEs.
Apr 02, 2017
Pharmaceutical Technology
The primary impact of using the covalidation model is the expedited analytical method qualification of both the transferring and receiving laboratories.
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