Bioanalysis and Pharmacokinetic Studies

Abstract

Biography: Maria Veneziano is currently a Research Investigator in the DMPK unit at IRBM (Pomezia, Italy), an Italian CRO and biotech company specializing in preclinical drug discovery of small molecules, peptides and antibodies. She studied Biological Science at ‘Federico II’ University of Naples (Italy) and completed her PhD in Medical Biotechnologies at Merck Research Laboratories (MRL) in Rome (Italy) developing bioanalytical methods used to identify and quantify amino acids and acylcarnitines for the diagnosis and follow-up of inborn errors of metabolism. As part of the DMPK team at MRL, she was involved in PK and ADME profiling of small molecule and peptide candidates for drug-discovery programs. Presently, Maria leads a group supporting PK and PK/PD studies for small molecules and peptides. Maria Veneziano speaks to the International Journal of Pharmacokinetics about her experience working on pharmacokinetic studies. She starts by discussing the conventional bioanalytical methods used for the quantitative analysis of small molecules and peptides and she highlights the important role of LC–MS detection and sample preparation in the bioanalysis of pharmacokinetic studies. She also speaks about the role of high-resolution mass spectrometry in the bioanalysis of peptides as an important tool in a drug-discovery program to simultaneously define pharmacokinetic and metabolic profiles of the same drug candidate. She also describes cassette dosing and cassette analysis approaches as strategies to increase sample throughput, highlighting advantages and limits of each of these strategies. Finally, Maria speaks about her idea of ‘simplified PK workflow’ based on the miniaturization and automation of all the steps in a PK study, from in vivo administration to sample analysis.