Bioanalytical method development and validation are at the forefront of ensuring rigorous, reproducible and reliable data in both drug development and clinical diagnostics. The field encompasses the ...

This field has evolved considerably through the integration of systematic design strategies, notably the incorporation of Analytical Quality by Design (AQbD) principles and robust statistical tools ...

The "Validation, Verification and Transfer of Analytical Methods (Understanding and implementing guidelines from FDA/EMA, USP and ICH) - Seminar Materials" report has been added to Research and ...

Bioassay variability can pose significant challenges due to laboratory conditions, instrumentation, analytical software, cell culture performance and reagent sourcing. These inconsistencies can impact ...

As drug development becomes more complex, so do the demands for accurate, reproducible bioanalytical data to prove their safety and efficacy. Method validation ensures the reliability of ...