Incorporation Of Microsampling Techniques In Bioanalytical Assays…
Current pharmacokinetic (PK) and toxicological studies pose an increasing demand on the volume of blood available from study animals, especially when the study involves small rodents. As a response, microsampling techniques have been introduced into bioanalytical studies.
Dried blood spots (DBS) and capillaries are the two most commonly used microsampling techniques. In this presentation, we present how microsampling can generate high quality bioanalytical data and accurate PK profiling, we also present a unique sample handling method utilizing pre-scored capillaries developed by Frontage (PA, USA), and how this overcomes some of the limitations with the conventional capillary microsampling approach.
Simultaneous Quantification Of Total Antibody And Antibody-Conjugated…
XMT-1522, an antibody-drug conjugate (ADC) currently in Phase I clinical development, represents the first Dolaflexin®-based, cleavable ADC with a high drug-antibody ratio (DAR). In this work, a novel immunocapture LC–MS/MS method was successfully developed for the simultaneous quantification of both total antibody and cleavable antibody-conjugated drug auristatin F-hydroxypropylamide (AF-HPA) in human plasma. This method utilized microwave-assisted enzymatic digestion for the total antibody and chemical release of the drug from ADC on a 96-well based immunocapture sample preparation platform. The total antibody and the conjugated drug AF-HPA were separated and subsequently quantified concurrently by LC–MS/MS. The linear range of the standard curve for total antibody was from 50 to 5000 ng/mL and for AF-HPA was from 3.3 to 330 ng/mL. The linearities showed R2 ≥ 0.993 for total antibody and R2 ≥ 0.996 for AF-HPA, respectively. The intra- and inter-day precision and accuracy were well within 15%. The validated method, with the characteristics of high efficiency, great selectivity, free of carryover, short LC–MS/MS time (˜3.5 min) and low sample volume (20 μl), was successfully applied for analyzing Phase 1 cancer patient samples.
Recruiting Women for First-in-Human Trials: Tips for Success
Programs that need to include women in their FIH studies will find that successful enrollment of women is achievable; however, it requires a concerted effort, with the correct strategies and proper support. In the following pages, we explore the challenges in recruiting women for FIH studies and present a set of practices that have proven successful towards improving the recruitment rates of women for these studies.