Genotoxic impurities (GTI) refer to compounds that can directly or indirectly damage cellular DNA, produce gene mutation or in vivo mutagenesis, and have the possibility or tendency to cause cancer.

The integration of a method validation, transfer, and verification process into the overall lifecycle management process of a product can best align the variability of the analytical procedure with ...

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 ...

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 ...

The attributes of the DS or DP that are to be tested to obtain the necessary information about product quality safety and efficacy are determined during the Drug Development stage. The information ...

Proprietary analytical method for precise Factor XI (FXI) measurement published in the Journal of Microbiology and ...

Nonclinical dose formulation analysis methods are used to confirm test article concentration and homogeneity in formulations and determine formulation stability in support of regulated nonclinical ...

The inclusion of even a small number of magnetic impurities in a metal can have dramatic effects on its physical properties, including its electrical resistivity and magnetic susceptibility. A well ...