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 ...

Computerized systems are those which comprise the components shown in Figure 1.1, namely, a computer system and a controlled function which is operating within its specified working environment. The ...

The Role of Analytical Method Development in CRDMO SuccessWhy Analytics Is a Pillar of Pharmaceutical DevelopmentIn today’s ...

The authors discuss the theory of ion mobility spectrometry, its benefit over HPLC analysis in cleaning verification, and the experimental considerations for method validation and validation. The ...

Producing cGMP biopharmaceutical products requires controlled, consistent performance of the manufacturing process. cGMP also requires controlled, consistent performance of analytical test methods.

DUBLIN--(BUSINESS WIRE)--The "Analytical Method Validation, Verification and Transfer Virtual Seminar (Oct 7th - Oct 9th, 2025)" has been added to ResearchAndMarkets.com's offering. Dependable ...

A simple, rapid, sensitive and accurate high-performance liquid chromatography method was developed and validated for the quantification of loratadine concentration in rabbit plasma using ...

Last week, Jeff Fredrick and I did a day-long code review of Platypus. We used a pair-programming approach, with Jeff driving and I helping with the navigation. Eventually, we got into the input ...