Adapted to perfection
The Iconovo devices are tested and veri ed with a model API and a model formulation. It is also veri ed mechanically according to applicable ISO standards (ISO 2027, 14969 and 14971).
To achieve the desired features and product per- formance, a development programme together with the client is required. During the development, the device is adapted for the speci c needs and requirement of the client. The exterior is designed to t with the clients brand identity and intended patient group. The device is also tuned to give the intended dose and performance. The device development work is carried out in parallel with the development of the drug formulation. The drug formulation can either be developed by the client or by Iconovo’s partners should the client prefer that.
Four different types of development programmes
- Development of a generic inhalation product. The product is registered based on therapeutic equivalence
- Development of a new inhalation product based on a generic API with established safety and ef cacy. The product is registered as a NDA with reduced safety and ef cacy programme
- Development of a new inhalation product based on a NCE. The product is registered as a NDA with full safety and ef cacy programme
- Phase I-II clinical trials using ICOone