Once a lead candidate has been selected for further clinical development, i.e. when the desired activity and safety of the active pharmaceutical ingredient (API) has been proven in animal models, the clinical development of the product needs to be started.
This usually starts with formulation development. This means a formulation suitable for administration to patients needs to be developed. This formulation needs to be such that the API remains stable during storage. Analytical methods need to be developed and validated during the analytical development. Furthermore the stability of the chosen formulation needs to be proven during a suitable stability program.
Svinx Consultancy has experience in all of these three phases and can help you in setting up the programs. For more development a new venture was started, OctoRelease.