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?
Category: Validation
Why are ‘Bio’ Test Methods so Tricky to Validate?
When it comes to validation, analytical test methods used for medicinal products based on biological molecules can be a bit ‘tricky’ to deal with. Coming up with a suitable design for the validation protocol can be quite difficult. In particular, the choice of what parameters to investigate, and the design of the associated experiments. What are the main reasons for this?
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.