Analytical Method Development

May 02, 2015
Pharmaceutical Technology
The rapid testing of biologic raw materials can lead to greater efficiency.
Apr 02, 2015
Pharmaceutical Technology
In this article, industry experts discuss critical analyses for demonstrating biosimilarity.
Feb 02, 2015
Pharmaceutical Technology
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.
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.
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