In the pharmaceutical industries, validation of analytical methods is a critical process that confirms the reliability and appropriateness of a method for its intended application. Method validation ...

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 ...

A QbD and lifecycle management approach to analytical method development and qualification will result in a better understanding and fewer failures of analytical methods due to more robust methods ...

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 ...

A look at using best practice tech transfer methods for CGTs to increase process and analytics robustness while being scalable. Cell and gene therapies (CGTs) are reshaping multiple therapeutic areas, ...

The Food and Drug Administration (FDA) recently issued a final guidance document, Validation and Verification of Analytical Testing Methods Used for Tobacco Products. This nonbinding guidance provides ...

1. Research that yields conflicting results rightly causes controversy. Where methodological weaknesses are apparent, there is ready opportunity for discord within the scientific community, which may ...

Analytical Quality by Design (AQbD) principles call for a deeper, more systematic understanding of all factors that influence the performance of analytical procedures in quality control. By embedding ...

Although advancements in analytical drug substance testing are being made, the increasing diversity of the therapeutic landscape is necessitating further innovation. The analytical testing of drug ...

Recent regulatory guidance has encouraged a lifecycle approach to pharmaceutical product development. One of the advantages of such an approach, including a Quality by Design (QbD) framework for ...