Application of ASAP in early API and formulation development

Application of ASAP in early API and formulation development

CLICK TO DOWNLOAD
CLICK TO DOWNLOAD

This presentation discusses the scientific and risk basis of using alternative stability assessment approaches in early API and formulation development.

During early clinical development, turnaround time is crucial to support a fast paced project timeline. Alternative approaches such as ASAP fits into the early development environment nicely for providing fit-for-purpose stability assessment of drug candidates and formulations prototypes. Example areas of application include but not limited to the following:

  • General stability screening of drug candidates
  • Establishing initial retest period for drug substances
  • Evaluate drug substances lot to lot stability variations
  • Evaluate stability of prototype formulations
  • Support process/formulation optimization
  • Support shelf life of clinical supplies