Generic API

When developing a product based on a generic API, the target and mechanism of the API are also well known.

The ef cacy and safety have also already been investigated and proven. A reduced clinical pro- gramme may therefore be used. The objective of this development is to develop a product with op- timized pharmaceutical and clinical performance.

After selecting a device, a requirement speci ca- tion is generated to detail how the device should be adapted to meet the client’s needs. In parallel with this, the drug formulation is developed by either the client or by an ICONOVO partner. The gure below shows a high level description of a development process. All ICONOVO develop-