Biologics exhibit greater variability in stability testing than do small-molecule drugs, and maintaining a stable test environment is crucial. A number of factors can influence stability, especially ...

In recent decades, shelf-life prediction is increasingly recognized as an important and necessary part of any new product development. Fully aware of this, CD Formulation, a New York-based CRO company ...

Harmonization of best practices and regulatory requirements will enable developers to find the best stability testing approach. Within the bio/pharmaceutical industry ...

Stability testing is essential in the pharmaceutical and biopharmaceutical industries. These tests are performed to evaluate the stability of drug products under various environmental conditions. Once ...

The introduction of biologicals into our drug armamentarium is complicating stability testing. For these complex molecules neither physicochemical data nor bioassays alone provide the complete picture ...

This is an intensive two-day masterclass that will help you get a deeper insight into: Analytical Quality by Design (QbD) and Lifecycle Management The Accelerated Stability Assessment Programme (ASAP ...

The purpose of the stability testing is to investigate how the raw materials or pharmaceutical preparations will change over time under the influence of temperature, humidity, and light, so as to ...

GMP release and stability testing are indispensable elements of the pharmaceutical sector’s quality assurance strategy. These testing protocols not only ensure that pharmaceutical products are safe ...