In the phase of formulation development, we usually test multiple variations. The final choice can only be based on the in vivo behavior. For this purpose, we begin early with studies on healthy volunteers. On the basis of these study results, the formula will be optimized and finalized.
In close cooperation with the regulatory authorities, we then plan a clinical development program for the final formula. Our experience and our goal-oriented work are to the direct and cost-effective way to approval.
This also applies to the support of our clients regarding clinical studies in phases I-II: from the first consultations with the authorities, to carrying out the studies and documentation, as well as the preparation of the data for approval, AMW GmbH can efficiently carry out approval processes worldwide.