An overview of trends in gene therapy, the unique analytical challenges posed by developing new treatments, and innovative solutions to address these challenges. Drug development is rapidly evolving, ...

The pharmaceutical industry is starting to apply a Quality by Design (QbD) approach to the development of pharmaceutical products. It follows therefore, that the analytical procedures which are used ...

In today’s pharmaceutical environment, where compliance and speed-to-market are paramount, analytical method development and validation play a foundational role. From early research through to GMP ...

Stay ahead of the curve with our 2nd edition Analytical Method Validation & Lifecycle Management Masterclass - US Edition. Learn about the latest ICH guidelines, including the new ICH Q14 for ...

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 ...

When evaluating a drug’s risk assessment for elemental impurities, one must consider all aspects of its lifecycle. A crucial step in achieving approval of a biosimilar is establishing analytical and ...