risk-based development

At our client’s request, we offer medicinal product development in accordance with the current requirements of the ICH-Q8 to ICH-Q10 Guidelines. This approach in medicinal product development – also called ‘Quality by Design’ (QbD) – as well as the principles of statistical Design of Experiments (DoE) is part of our range of services.

  • Preparation of a QbD requirements specification with the client
  • Definition of milestones
  • Carrying out of risk analyses
  • Creation and selection of a suitable DoE model
  • Carrying out of feasibility studies (optional DoE models)
  • Statistical evaluations of the formulation results
  • Scale up of prototype formulations from DoE studies
  • Stability testing of prototype formulations from DoE studies
  • Definition of the design window
  • Scale up establishment batches
  • Manufacture of validation and stability batches
  • Manufacture and release of clinical batches

Contact: Dr. Alexandra Keilbach-Bermann
Head of Drug Development / Head of Quality
Email: a.keilbach-bermann(at)hwi-group.de
Phone: +49 7805 401-502

Resistance to crushing of tablets

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