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 ...

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 ...

Good HPLC methods must satisfy both technical requirements (sensitivity, specificity, linearity, accuracy and precision) as well as business needs (reliability in routine use and a run time ...

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 ...

Advancing analytical techniques is all well and good, but unless those advances in technology are accompanied by matching strides in technique management, the true potential of better methods may not ...

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 ...

While proteins on the surface of cells are the targets for most drugs, refined methods are needed to analyse how these membrane proteins are organised. Researchers at Karolinska Institutet have ...