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 ...

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 ...

This article discusses why it is important to apply risk analysis, QbD, and DoE in the development of analytical methods. About a decade ago, FDA and other regulatory agencies introduced a series of ...

Dublin, Nov. 18, 2022 (GLOBE NEWSWIRE) -- The "Lifecycle Management of Analytical Methods and Procedures : Current Trends & Your Questions Answered" training has been added to ResearchAndMarkets.com's ...

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 ...

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 ...

Industry experts discuss the formulation and development issues that should be considered when addressing scale up from small-scale batches to commercial production. mguido/stock.adobe.com Editor's ...

Analytical methods must be validated to provide reliable data for regulatory submissions. These methods are essential for a number of purposes, including testing for QC release, testing of stability ...