Clinical Studies

Along with medical progress comes the continual development of new and better therapies for allergic overreactions.

Study Phases

To ensure the systematic collection of information in clinical studies, these are divided into four phases. Each phase is based on the information and experience gained from the previous phase.

Phase I

  • First administration to healthy individuals, after completed laboratory and animal experiments
  • Tolerance is determined
  • Absorption and mode of action / efficacy in the human body
When the tolerance of the investigational medicinal product in phase 1 has been proven, phase 2 commences.

Phase II

  • First administration to a small number of patients
  • Assessment of "efficacy"
  • Optimisation of the dosage
  • Monitoring of side effects
If a distinct efficacy of the new treatment method could be proven in phase 2, then phase 3 follows.

Phase III

  • Administration to a large number of patients
  • Monitoring of less frequent side effects
  • Precise optimisation of the dosage
  • Further cost benefit considerations
Phase 4 starts after the pharmaceutical has been approved and registered.

Phase IV

  • Extensive administration experience is sought
  • Investigation of interactions with other therapies and treatment methods
  • Survey of uncommon side effects