In the Discovery phase of the drug development pipeline, the advances in drug design and screening, continues to place pressure on analysis turnaround times. High quality data is required to make the “next-step” decisions on a faster time scale. Therefore, the concept of fit-for-purpose methods is gaining traction. The approach considers the analytical question being asked and the certainty in the data that is required to confidently answer those questions. In other words, not all questions need a method validated with the rigors of regulator guidelines. Instead, an iterative approach is adopted, typically three tiers, and proposed, based on the clients’ needs.
KCAS has a significant infrastructure in LCMSMS method development and leverages that infrastructure to provide high quality with rapid turnaround time. in achieving this, we utilize a fit-for-purpose acceptance criteria and qualification experimental design, along with a peer reviewed reporting system. KCAS uses a three tiered approach (Research Grade level 1-3) to suggest increasing levels of bioanalytical method performance, to meet our clients Discovery needs in both turn around time and cost.
KCAS is the Discovery support team of choice! We have extensive expertise in bioanalytical method development to provide high quality data with quick turnaround times. Our client focused approach allows us to listen to the customer’s needs, and develop a method that will meet the objectives of the study. We have a successful record of taking on challenging projects, while maintaining our rapid turnaround times to meet the needs in the fast paced realm of Drug Discovery.