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 ...

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 ...

DS InPharmatics Head of Analytical Services, Colman Byrne joins the show to share his experience in analytical method development and validation. Colman is the most senior analytical services expert ...

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

The attributes of the DS or DP that are to be tested to obtain the necessary information about product quality safety and efficacy are determined during the Drug Development stage. The information ...

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 ...