What parameters should I test when performing method verification?

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Alexis St-Gelais

Hello,

I suggest that you take a look at this set of very good publications regarding method validation by the total error approach. Instead of looking at sets of defined parameters such a linearity, the whole process rather checks how well your analysis is able to trace back a reliable and unbiased concentration of your analyte. If, after testing, your method constitently gives the true concentration of known preparations of analytes, it can be considered selective, reliable and validated. It is a very practical approach, and is gaining more and more acceptance within the scientific community.

The part I article explains it quite well. The other articles are there to go more in-depth. Also be aware that, depending on your lab's capacities, there are softwares to help you carrying out this type of validation procedure, such as e-noval. However, if you are comfortable with Excel and maths, you should be fairly well able to create datasheets to do that yourself, with a few days of work and double-checks.

Article Harmonization of strategies for the validation of quantitati...

Subrata Bhadra

Hi Nidal,

If you are an amateur researcher in this field, then try to understand at least the following two ICH guidelines:

1. ICH Q1A(R2) Guideline on "Stability Testing of New Drug Substances and Products"

2. ICH Q2(R1) Guideline on "Validation of Analytical Procedures: Text and Methodology"

Just google these to download. If you find any ambiguity, then as a supplement, download one of my publications regarding this field. Here is my paper:

Article The ICH guidance in practice: Stress degradation studies on ...