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 ...

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 ...

The 2013 PDA Analytical Methods Development and Validation Workshop will bring together industry professionals of all levels to network and benefit from updates on recent regulatory guidance's ...

The new method allows researchers to directly separate the nanoparticles according to their size and investigate their structure by X-ray scattering. Messenger RNA (mRNA) nanomedicines, a ...

Analytical methods and tools play a pivotal role in cleaning validation. Validating the effectiveness of the cleaning of pharmaceutical manufacturing and process equipment is part of good ...

In the pharmaceutical industries, validation of analytical methods is a critical process that confirms the reliability and appropriateness of a method for its intended application. Method validation ...

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 ...

Monique Paré Speirs is a researcher and method developer for Rhyz Analytical Labs (a Nu Skin company), a QC testing lab for raw materials, dietary supplements, cosmetics, and personal care products.