This article describes the efficient development of robust analytical methods based on Analytical Quality by Design (AQbD) using dedicated LabSolutions MD software, which supports each phase of the ...

In the past 10 years, the pharmaceutical industry has been moving towards a design space approach to development and manufacture – an approach that has been defined by ICHQ8, Q9 and Q10, and 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 ...

With the publication of ICH Q2(R2) and ICH Q14, the modern Quality by Design (QbD) paradigm introduced by ICH Q8 for manufacturing has now been extended to Quality Control (QC). A life cycle and ...

The development and release of pharmaceutical products require the use of modern, efficient, and adaptable analytical techniques to assure efficacy and patient safety. The growing interest in complex ...

A one-of-a-kind, user-friendly software, LabSolutions MD integrates method scouting, data acquisition, and data processing, and uses analytical quality by design (AQbD) principles, to save users time ...

Aseptic processing demands reliable, robust, and validated analytical methods to ensure sterility, safety, and quality, ...