From bench to bedside: navigating bioanalytical method development and validation for clinical efficacy and regulatory compliance
Year: 2025
Type: article
Abstract: Bioanalytical methods are indispensable in pharmaceutical development, serving as the backbone for ensuring clinical efficacy and regulatory compliance. The development and validation of these methods face numerous challenges for improved clarity and flow, as recommended. Biological matrices such as blood, plasma, urine, and tissues often contain endogenous substances that interfere with analyte detection, complicating efforts to achieve accuracy and reliability. These challenges highlight the need for innovative strategies to optimize bioanalytical methods for both clinical and regulatory success.
Source: Cell and Gene Therapy Insights
Author: Preeti Misra
Language: English
Subfield: Immunology
Field: Immunology and Microbiology
Domain: Life Sciences
Open Access status: hybrid
OpenAlex ID: W4417245593