Lab Automation and Regulatory Compliance
Automation has the potential to enhance scientific rigor and operational efficiency while solving long-standing regulatory issues.
As drug development becomes more complex, the demand for accurate and reproducible bioanalytical data increases to prove safety and efficacy.
Method validation ensures the reliability of pharmacokinetic (PK), toxicokinetic (TK), and biomarker data, which becomes the foundation for regulatory submissions and safety and efficacy decisions.
Recent regulatory guidelines, such as ICH M10, unify and modernize standards, but implementing these standards consistently remains a challenge due to human error, workflow considerations, and increasing data requirements.
Automation holds the potential to enhance scientific rigour and operational efficiency while solving long-standing regulatory conundrums.
Author's summary: Automation enhances regulatory compliance.