When I forcibly degrade my drug or drug product to create degradation products, how much degradation should I aim for?
Tag: Validation
Do I Have to Revalidate a Method if the HPLC Column is Changed?
I would like to have a ‘back-up’ column for my HPLC method so that I am not reliant on one supplier, but how can I choose one that will be suitable and do I need to validate the method fully on the replacement column?
What is Mass Balance in a Forced Degradation Study?
What is the ‘mass balance’ for an analytical method and is it critical that I investigate it as part of method development or method validation?
A Wish List for ICH Q2(R2), the Revision of the Guideline on Method Validation
The ICH guideline on method validation, Q2 (R1) [1], is currently being updated and I thought it might be interesting to put together a wish list for the changes that I would like to see in the new version. Rather than a wide-ranging treatment of all analytical method validation related issues, such as how it […]
Where do the Acceptance Criteria in Method Validation Come From?
One of the most difficult tasks when writing an analytical method validation protocol is to set suitable acceptance criteria, particularly for the characteristics of accuracy and precision. It sometimes seems that the values are just plucked out of the air! Available guidance documents, such as ICH Q2(R2), don’t mention any numbers.