Analytical Method Development

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.
Aug 01, 2012
Pharmaceutical Technology Europe
Cleaning validation provides assurance that the quantity of residual substances collected from equipment surfaces are within permissible limits, helping to ensure quality control and safety in pharmaceutical manufacturing facilities. Three different cleaning validation methods for measuring the carbon in residual samples of various pharmaceutical substances were compared.
Aug 01, 2012
Pharmaceutical Technology Europe
By Pharmaceutical Technology Editors
The authors, part of the International Consortium on Innovation and Quality in Pharmaceutical Development (IQ Consortium), explore and define common industry approaches and practices when applying GMPs in early development.
Jul 18, 2012
Equipment and Processing Report
By Pharmaceutical Technology Editors
We have developed an in-house broth to neutralize a preservative for traditional microbiological testing following USP <61> Microbiological Examination of Non-Sterile Products: Microbial Enumeration Tests. We would like to use a rapid method to release product faster, but is there a broth that will be effective on our products?
native1_300x100
lorem ipsum