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 ...

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 ...

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 ...

(MENAFN- GlobeNewsWire - Nasdaq) Market opportunities exist in the development and validation of liquid chromatography methods and instruments for pharmaceuticals, emphasizing compliance with ...

Erik Konings, former Nestlé expert and SPIFAN consultant, explains why global testing standards are vital for the safety and ...

The Food and Drug Administration (FDA) has issued new draft guidance signaling a policy shift toward reducing the need for comparative efficacy ...

Market opportunities exist in the development and validation of liquid chromatography methods and instruments for pharmaceuticals, emphasizing compliance with stringent US EPA and FDA standards to ...