Peer-Review Research

Aug 02, 2013
Pharmaceutical Technology
By Pharmaceutical Technology Editors
The authors examine alternative solvents for extractables and leachables screening evaluation of process components that provide extraction equivalence and do not interfere chromatographically.
Jul 02, 2013
Pharmaceutical Technology
The author discusses the purpose of analysis and testing and the implications for specifications and their underlying statistical distribution.
Jun 02, 2013
Pharmaceutical Technology
By Pharmaceutical Technology Editors
The authors report on the range and distribution of grow-out times for biological indicators exposed to sublethal sterilization processes.
Jun 02, 2013
Pharmaceutical Technology
The authors discuss three methods for identification of out-of-trend (OOT) results and further compare the z-score method and the tolerance interval in OOT analysis for stability studies.
May 02, 2013
Pharmaceutical Technology
By Pharmaceutical Technology Editors
The author provides a review of FDA's guidance document, Guidance for Industry: Q11 Development and Manufacture of Drug Substances, and its relation to the International Conference on Harmonization's Q11 document and its application to the industry.
May 02, 2013
Pharmaceutical Technology
By Pharmaceutical Technology Editors
The author examines dry dispersion and outlines the related analytical method development.
Apr 02, 2013
Pharmaceutical Technology
The miniaturization of preclinical safety assessment studies using a microfluidic chip system and optical microscopy can help reduce compound requirements, time, and costs in formulation development.
Apr 02, 2013
Pharmaceutical Technology
The authors describe a method-validation-by-design (MVbD) approach to validate a method over a range of formulations using both design-of-experiment and quality-by-design principles to define a design space that allows for formulation changes without revalidation.
Mar 02, 2013
Pharmaceutical Technology
By Pharmaceutical Technology Editors
The authors review developments in wet granulation using a twin-screw extruder.
Mar 02, 2013
Pharmaceutical Technology
By Pharmaceutical Technology Editors
The authors demonstrate that using supercritical fluid chromatography offers distinct advantages in speed and in clean isolation of the desired peaks.
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