This ‘In the Zone’ discusses the importance of data management. Data management is a common term used in almost all industries and it comprises all disciplines related to managing data as a valuable resource.
In this research article, published by Bioanalysis, investigators from Biogen (MA, USA) and Stat4ward LLC (PA, USA) describe their re-evaluation, in singlet, of data from five pharmacokinetic assay validations and five clinical and preclinical studies, originally run in duplicate. The results of the study confirm that well-developed ligand-binding assays (LBAs) produce comparable data whether evaluated in singlet or duplicate.
Approaches to improve drug tolerance and target tolerance in the assessment of neutralizing anti-drug antibodies
In this research article, published by Bioanalysis, investigators from Janssen Research & Development LLC and Thomas Jefferson University (both PA, USA) describe potential approaches for enabling the development of reliable neutralizing anti-drug antibody (NAb) assays that overcome drug and drug target interference for more precise and sensitive NAb assessment.
In this perspective article, published by Bioanalysis, the authors present the current regulatory recommendations for bioanalytical support of adeno-associated virus-based gene therapy development.
Gene therapy is an experimental technique that involves the delivery of therapeutic nucleic acid polymers into a patient’s cells to treat or prevent a disease.
Ensuring biological sample integrity from collection to analysis for LC–MS workflows: case studies illustrating challenges in clinical trials
In this special report, Melanie Anderson (Merck and Co., Inc.; PA, USA) presents several case studies to demonstrate the logistical challenges associated with unstable compounds and unique matrices for LC–MS/MS workflows.
Rawi Ramautar Biomedical Microscale Analytics Leiden Academic Centre for Drug Research Leiden University, The Netherlands…
In this interview, Chris Zhu (The Ohio State University) discusses what mass spectrometry-based volatilomics techniques currently exist and how these can be used to analyze biological samples.
In this editorial, the author discusses the progression of the metabolomics field, the growing number of databases that are appearing and new separation techniques such as ion mobility, which are adding a fourth dimension to identification capabilities.
Metabolomics is defined as the identification and quantification of metabolic products in a biological system. As part of this Spotlight, we explore the recent advances in target and untargeted metabolomics and review the use of metabolomics in drug development and precision medicine.