Preformulation

 

When selecting a new drug-candidate and initiating its Phase I development, a “Preformulation Package” data set has to be assembled, in order to:

  • Secure the compound selection final decision
  • Prevent potential issues in the production of the first API GMP batch
  • Facilitate the analytical and formulation development work by producing a detailed and focused description of the compound profile
  • Ensure appropriate CMC documentation is prepared to support ethics and regulatory submissions

 

Drugabilis Preformulation Package is customized to the targeted administration route to help define the most suitable drug delivery options.


Drugabilis has developed experimental methodologies to quickly and accurately deal with small API quantities (e.g. tens of milligrams).