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 ...

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 ...

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 pharmaceutical industry has traditionally controlled analytical methods via a well-defined sequence of development, validation and transfer exercises in line with agreed standards such as ICH Q2.

The pharmaceutical industry is implementing Quality by Design (QbD) and Process Analytical Technology (PAT) more and more, making their symbiotic nature even more obvious. PAT and QbD are catalysts ...

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 ...

Whether you’ve already implemented the recommendations of ICH Q14/Q2(R2) and USP <1220>, or if you’re just getting started, Waters™ Empower™ Chromatography Data System (CDS) is packed full of ...