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 ...

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 ...

Thought and foresight into method development stages can ensure costly errors and delays are avoided later on. Method development is a critical and continuous process that, if optimized, ensures ...

BOCA RATON, Fla.--(BUSINESS WIRE)--LGM Pharma today announced the launch of its new Analytical Services offering that provides analytical testing and stability services to pharmaceutical developers ...