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 ...

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 ...

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 ...

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 ...

The 5th volume of Recent Advances in Analytical Techniques contains five comprehensive chapters. The concepts described in this volume reflect the important recent advances in analytical chemistry ...

Vector BioPharma AG (Vector BioPharma), a biopharmaceutical company aiming to transform the safety, efficacy, and specificity of drug delivery to improve treatments for patients, today announced that ...

Analytical methods development and validation play important roles in the discovery, development, and manufacture of pharmaceuticals. The official test methods that result from these processes are ...

Regulatory expectations and requirements continue to evolve to ensure the quality and safety of drug products. Over the last five years, we have seen increased focus during regulatory inspections ...