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 ...

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 ...

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 ...

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 ...

DSI can supervise the development of analytical methodologies for use in the control of starting materials, drug substances, and drug products. Image Credit: DS InPharmatics This covers the complete ...

When transferring a method from R&D to quality control, success hinges on discovering where “the best” and “the most reliable” intersect. MINERVA STUDIO - STOCK.ADOBE.COM Analytical method transfer ...

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 ...

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