A research team from the Hefei Institutes of Physical Science of the Chinese Academy of Sciences has proposed a novel model optimization algorithm—External Calibration-Assisted Screening (ECA)— that ...

Interphex2007, New York, NY (Apr. 26)-Robustness studies for analytical methods are critical in being able to provide the assurance to the quality of an analytical method, a topic addressed in a ...

FDA’s Analytical Procedures and Methods Validation for Drugs and Biologics, Guidance for Industry, July 2015 (4) ICH guideline Q2 ... quantitation limit, linearity, range, and robustness. These ...

ANOVA - a robust statistical tool for determining intermediate precision in analytical method validation: K. Sadasivan Pillai Wednesday, February 12, 2025, 08:00 Hrs [IST] In the pharmaceutical ...

LCGC International interviewed Bob Pirok from the University of Amsterdam, Netherlands to discuss strategies for enhancing ...

Define the parameters used for method validation, i.e. the validation characteristics as per ICH Q2(R1) of: specificity, accuracy, range, linearity, precision, detection limit, quantitation limit and ...

Robust methods are those that work even in a challenging manufacturing environment and when the method can't directly control all the variables. Quality Control Methods.

Define the parameters used for method validation, i.e. the validation characteristics as per ICH Q2(R1) of: specificity, accuracy, range, linearity, precision, detection limit, quantitation limit and ...