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 ...

The authors describe a method-validation-by-design (MVbD) approach to validate a method over a range of formulations using both design-of-experiment and quality-by-design principles to define a design ...

Recent guidance from regulators emphasizes bioassays and potency assurance strategies, underscoring the robustness of these ...

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 ...

Selecting the right deconvolution method to analyze the composition of complex mixtures of cells just got easier. Researchers derived clear guidelines scientists can use to determine the deconvolution ...

Background: Although several tools to evaluate the credibility of health care guidelines exist, guidance on practical steps for developing guidelines is lacking. We systematically compiled a ...