Quality by Design (QbD) Approach for a Nanoparticulate Imiquimod Formulation as an Investigational Medicinal Product

• Main Authors: Jonas Pielenhofer (Author), Sophie Luise Meiser (Author), Karsten Gogoll (Author), Anna-Maria Ciciliani (Author), Mark Denny (Author), Michael Klak (Author), Berenice M. Lang (Author), Petra Staubach (Author), Stephan Grabbe (Author), Hansjörg Schild (Author), Markus P. Radsak (Author), Hilde Spahn-Langguth (Author), Peter Langguth (Author)
• Format: Book
• Published: MDPI AG, 2023-02-01T00:00:00Z.
• Subjects: article
• Online Access: Connect to this object online.

The present article exemplifies the application of the concept of quality by design (QbD) for the systematic development of a nanoparticulate imiquimod (IMQ) emulsion gel formulation as an investigational medicinal product (IMP) for evaluation in an academic phase-I/II clinical trial for the treatme...