Volumetric absorptive microsampling combined with impact-assisted extraction for hematocrit effect free assays.

AIM: Volumetric absorptive microsampling (VAMS) is a recent technology available for sampling and analyzing low blood volume. The present work describes the utilization of VAMS for the quantitation of naproxen and ritonavir in human blood using a novel bead-based impact-assisted extraction (IAE) procedure. RESULTS: Sampling volume accuracy of the VAMS device was independent of the blood hematocrit (HCT) level, however analyte recovery decreased with increasing HCT when extracted using ultrasonication. In contrast, IAE was unaffected by HCT, resulting in quantitative recovery for all levels evaluated. Precision and accuracy batches, as well as matrix effect evaluation, met acceptance criteria. CONCLUSION: The IAE procedure coupled with VAMS is immune to HCT biases affecting sampling volume and recovery.

Choosing the appropriate matrix to perform a scientifically meaningful lipemic plasma test in bioanalytical method validation.

Laurence Mayrand-Provencher has obtained a Master of Science in Chemistry from Université de Montréal. With over 3 years of experience as a scientist in the bioanalysis industry, he is now a scientist in method development at Algorithme Pharma. His experiences have led him to conduct robust and effective method development of bioanalytical assays, specifically in the LC-MS/MS field. Many regulatory agencies include in their guidelines the need to investigate the effect of lipemic plasma on the reliability of the data as part of a bioanalytical assay validation. Lipids can cause matrix effect, specificity and recovery issues, which can potentially lead to inaccurate data if left unaccounted for. However, finding the appropriate matrix type to be used to perform a lipemic plasma test is a major challenge, as the differences between those commercially available are not well known. The work reported herein describes the differences in lipid content between normal plasma, synthetic lipemic plasma mixes, and two types of natural lipemic plasma. The results obtained show that natural plasma with high triglycerides content should be used to perform a scientifically meaningful lipemic plasma test.

2013 White Paper on recent issues in bioanalysis: 'hybrid'--the best of LBA and LCMS.

The 2013 7th Workshop on Recent Issues in Bioanalysis was held in Long Beach, California, USA, where close to 500 professionals from pharmaceutical and biopharmaceutical companies, CROs and regulatory agencies convened to discuss current topics of interest in bioanalysis. These 'hot' topics, which covered both small and large molecules, were the starting point for fruitful exchanges of knowledge, and sharing of ideas among speakers, panelists and attendees. The discussions led to specific recommendations pertinent to bioanalytical science. Such as the previous editions, this 2013 White Paper addresses important bioanalytical issues and provides practical answers to the topics presented, discussed and agreed upon by the global bioanalytical community attending the 7th Workshop on Recent Issues in Bioanalysis.