Analytical Method Development

Feb 02, 2015
Pharmaceutical Technology
By Pharmaceutical Technology Editors
Ligand-binding assays are fundamental to characterizing biosimilars.
Nov 15, 2014
Pharmaceutical Technology
The authors describe a rapid, single-point calibration approach for ICP–MS analysis of raw materials used in drug product manufacturing.
Nov 15, 2014
Pharmaceutical Technology
The authors present a validation study of an analytical method for the simultaneous determination of nine human cytokines in human K2-EDTA plasma.
Nov 15, 2014
Pharmaceutical Technology
Analytical procedures and method validation should be developed with a structured and rigorous approach.
Nov 15, 2014
Pharmaceutical Technology
Methods must be suitable at each development phase, robust, and effective on multiple platforms.
Nov 15, 2014
Pharmaceutical Technology
Advanced analytical methods are speeding up the targeted evaluation of potential viral contaminants.
Oct 02, 2014
Pharmaceutical Technology
By Pharmaceutical Technology Editors
A risk-based approach is recommended for analytical method comparability for HPLC assay and impurities methods.
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
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