Are multimetabolite methods fit-for-purpose for supporting toxicology studies?
"Despite current regulatory and scientific thinking on this subject, there still seems to be a consensus in parts of the industry that drug metabolites should be measured whenever possible..." The measurement of parent drug in biological samples is an integral part of the drug-development process from discovery support through to late phase clinical development. At some point during this process it may also be necessary to measure metabolites of the drug. The regulatory guidelines on metabolite safety testing outline metabolite exposure data that is required to support drug registration. There are also a number of publications that describe strategies for...