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 ...

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 ...

Novel molecular formats - Fc-fusion proteins, bispecific antibodies, and Fab fragments - are driving therapeutic ...

Nitrile and latex gloves that scientists wear while they are measuring microplastics may lead to a potential overestimation of the tiny pollutants, according to a University of Michigan study, ...

Susan J. Schniepp, distinguished fellow for Regulatory Compliance Associates, and Shiri Hechter, senior lab operations manager for Nelson Laboratories, provide a simple approach to validating ...

The devices around us that generate and store the energy that powers our electronics and propels our vehicles rely on intricate chemistry that often happens in tiny spaces. But those ...

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 ...

Different regions of the United States are experiencing different patterns of warming climate, requiring region-specific adaptation, according to a study published in PLOS Climate by María Dolores ...