We are pleased to announce that we have a new course on the topic of the draft ICH guidance documents, Q2(R2) and Q14, that is aimed at both our previous learners who have completed our validation course, and also at anyone who is experienced in validation and wants to know more. The course is currently […]
The MTS course schedule for 2023 is now available For more information on any of our training courses, select from the course list. Contact us if you have any questions.
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. We have modified our courses, ‘Validation, Verification & Transfer of Methods for Pharmaceutical Analysis,’ and, ‘Validation, Verification & Transfer of Methods for Biopharmaceutical Analysis‘, to ensure that […]
Defined as “the lowest amount of analyte in a sample which can be quantitatively determined with suitable precision and accuracy” in ICH Q2(R1), limit of quantitation (or ‘quantitation limit’ in the ICH terminology) is an important method performance characteristic which is typically demonstrated during analytical method validation. Although the concept of limit of quantitation (LOQ) […]
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: […]
Question: 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? Answer: When used in the context of an analytical method, the term ‘mass balance’ relates to its ability to analyse the degradation products of a drug molecule. A method […]