The MTS consultant, Oona McPolin, will deliver a presentation entitled, ‘Challenges in Development and Validation of Stability Indicating Methodology‘ at the JPAG symposium, ‘Stability VI’ on the 30th June 2022, which will be held at the Royal Society of Chemistry in Burlington House, London. If you are interested in the analytical methodology used for supporting […]
Category: Validation
Limit of Quantitation: Does it Matter?
MTS HELPDESK:
Is the limit of quantitation always important when validating methods for impurities?
Drafts of ICH Q2(R2) and Q14 on Public Consultation
Draft versions of the revision of ICH Q2, Validation of Analytical Procedures, and also the new guideline Q14, Analytical Procedure Development, were published on the 24th March 2022. The deadline for comments is 31st July 2022. You can view the draft guidelines, and also a presentation from ICH about the guidelines, using the following links: […]
How Much Forced Degradation in a Stress Study?
When I forcibly degrade my drug or drug product to create degradation products, how much degradation should I aim for?
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?
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?