OR WAIT null SECS
November 15, 2014
The authors present a validation study of an analytical method for the simultaneous determination of nine human cytokines in human K2-EDTA plasma.
The authors describe a rapid, single-point calibration approach for ICP–MS analysis of raw materials used in drug product manufacturing.
September 02, 2014
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.
September 01, 2014
Changing regulations are impacting the identification and monitoring of variable materials in excipients.
August 01, 2014
Developments in chromatography column technology to deliver greater efficiency, speed and inertness benefit the drug development process from discovery to manufacturing and quality control.
Contract research, development, and manufacturing organizations invested in new facilities and technologies in 2014 for analytical testing, as well as small- and large-molecule drug development.
Experts from contract testing laboratories and service organizations shared their perceptions of analytical testing advances, and challenges still ahead.
May 02, 2014
Industry experts discuss how extractables and leachables studies are designed using a risk-based approach.
Data integrity in the analytical laboratory is an area of increasing focus for regulators such as FDA.
February 01, 2014
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.