Bioanalytical Validation: Adapting to Technology and Regulations
Received Date: Oct 01, 2025 / Published Date: Oct 29, 2025
Abstract
This compilation highlights contemporary advancements and challenges in bioanalytical method validation across diverse platforms and applications. It covers regulatory guidelines like ICH M10, specialized validation for LC MS MS, biomarkers, and cell based assays, and considerations for biosimilars and novel technologies such as microfluidics and dried blood spot sampling. Discussions extend to therapeutic drug monitoring, method transfer, and immunogenicity assays, emphasizing the need for robust, fit for purpose validation strategies. The overarching theme is the critical importance of ensuring method accuracy, precision, and reliability for drug development, regulatory compliance, and patient care in an evolving analytical landscape.
Keywords: Bioanalytical Method Validation; ICH M10 Guideline; LC-MS/MS; Biomarkers; Cell-Based Assays; Biosimilars; Microfluidic Platforms; Therapeutic Drug Monitoring; Dried Blood Spot; Immunogenicity Assays
Citation: Jensen O (2025) Bioanalytical Validation: Adapting to Technology and Regulations. jabt 16: 811. Doi: 10.4172/2155-9872.1000811
Copyright: © 2025 Oliver Jensen This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution and reproduction in any medium, provided the original author and source are credited.
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