To make work easier, I’d like to continue with our already started template series and today I’d like to post a template that can be used during method validations to evaluate the validation parameter precision (including repeatability, instrumental precision, and two versions for intermediate precision).
A wide variety of analysis methods are used in the pharmaceutical quality control laboratory. In addition to methods to proof the identity of the active pharmaceutical ingredient and qualitative tests, quantitative determinations are also included. A (calibration) standard of different concentrations is run in parallel within each analysis and the intensity of the measurement signal (detector response) is then plotted against the concentration.
If you are just approaching the topic of method validation, you may be faced with the question which analytical methods are actually affected by method validation.
To answer this question, we have to clarify which methods are used when and for what purpose.
And once again a technical book accompanied me on vacation and aided in avoiding my gray matter to rust completely ;-)
I’d like to use this blog article to describe my impressions of the book “Drug Development and Market Authorization” by Niels Eckstein (2nd edition from 2018, published by Deutscher Apotheker Verlag Stuttgart, ISBN: 978-3-7692-6992-5).