Analytical Method Development

Sep 02, 2014
Pharmaceutical Technology
The quality-by-design principles used to control process variability are equally important to measurement systems because process variability includes contributions from measurement system variability. The authors use real-life examples from drug development projects to outline how an understanding of chromatographic measurement system variability might be achieved.
Feb 01, 2014
Pharmaceutical Technology
By Pharmaceutical Technology Editors
For a drug-development process that relies on outsourced services, special considerations are needed to ensure the proper transfer of technology and information from one phase to the next.
Sep 25, 2013
Pharmaceutical Technology
The characteristics of tableted solid dosage drugs often depend on the granulation process, so selecting the most appropriate granulation technique and monitoring the process are crucial
Sep 12, 2013
By Pharmaceutical Technology Editors
FDA updates guidance to reflect advances in technology.
Aug 01, 2013
Pharmaceutical Technology
By Pharmaceutical Technology Editors
Michael Rooney, director, bioanalytical development at Jazz Pharmaceuticals, provides an overview of a life cycle strategy for analytical methods development, the need for standards and guidance documents, and therole Quality by Design can play in method development.
Jun 12, 2013
Pharmaceutical Technology
Now at a practical size and price, terahertz spectroscopy is advancing as a nondestructive method of analysis for solid forms and tablet coatings.
Apr 24, 2013
Pharmaceutical Technology
New capillary-based imaging techniques for protein charge variant analysis are reducing development and start-up times for protein-based therapeutics.
Apr 10, 2013
Pharmaceutical Technology
Iterative and multiple incremental advances in particle-characterization technology are making a difference in pharmaceutical analysis applications.
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.
Oct 02, 2012
Pharmaceutical Technology
By Pharmaceutical Technology Editors
The authors describe how traditional approaches to analytical method and validation may benefit from alignment with quality-by-design concepts.
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