Current Perspective on Bioanalytical Method Optimisation with Emerging Challenges like ICH M10 Guideline Interpretation & Nitrosamines Infringement

The continuous evolution in bioanalytical method optimization calls for a reassessment of traditional protocols, particularly with the introduction of the ICH M10 Bioanalytical Method Validation (BMV) guideline. Inherent dynamism of regbio direct bioanalytical expert to revisiting the established approaches to bioanalytical method development and pre-method validation (PMV) protocol, with a focus on enhancing strategies for selectivity and reproducibility in alignment with ICH M10 directives.

Through our collective experience of 2.5 decades, a critical aspect is to address the growing challenge of nitrosamines, which are increasingly impacting not only pharmaceutical drug development but also bioanalysis, clinical research, food safety, and environmental monitoring. There is an utmost need to delve into the regulatory, analytical, and scientific ramifications of nitrosamine contamination across these sectors.

Brainstorming a comparative analysis of traditional versus advanced bioanalytical practices, emphasising necessary adaptations to meet current guidelines and addressing infringing and interfering risks with respect to method optimisation aimed at fostering collaborative problem-solving and identifying innovative strategies for optimizing bioanalytical methods in this dynamic regulatory and scientific landscape.

Key Words:Method Development and Finalization. Nitrosamines Infringement. ICH M10 BMV Guidance Interpretation. Regulated Bioanalysis. BMD&F Mitigation strategies.