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

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

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...

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Bibliographic Details
Main Authors: Jonas Pielenhofer, Sophie Luise Meiser, Karsten Gogoll, Anna-Maria Ciciliani, Mark Denny, Michael Klak, Berenice M. Lang, Petra Staubach, Stephan Grabbe, Hansjörg Schild, Markus P. Radsak, Hilde Spahn-Langguth, Peter Langguth
Format: Article
Language:English
Published: MDPI AG 2023-02-01
Series:Pharmaceutics
Subjects:
quality target product profile
critical quality attributes
GMP
nanoparticles
design of experiments
IMI-Gel
Online Access:https://www.mdpi.com/1999-4923/15/2/514

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https://www.mdpi.com/1999-4923/15/2/514

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