Description
Effective forced degradation strategies assessing the stability in early phase of drug development is vital for the long term success of any drug. Analytical techniques are very sensitive to support very low levels of detection (LOD) and quantitation (LOQ). In recent years, analytical technologies have advanced so much that the detection of impurities at very low levels has become significantly less complex, though it still poses numerous challenges.
Learn, discuss and gain knowledge on:
Forced degradation studies: groundwork and practical aspects
Forced degradation concepts for small and big molecules
Drug degradation chemistry within drug discovery
Bioassays for assessing degradation
Monitoring and evaluation of single amino acid modifications of therapeutic monoclonal antibodies
Pre-formulation of proteins by high-throughput techniques
Rapid and robust excipient selection during formulation development
Comparing two different excipient screening approaches for the same drug
Integrated approach to detect and quantify genotoxic impurities in APIs
Quality by Design (QbD) application to GTI control strategy
In silico Prediction of forced degradation
Regulatory perspectives on drug degradation and stress testing
