Abstract
The foregoing sections described the methods of manufacturing and characterization of pharmaceutical particulate systems. Scrutiny of these systems defines key physicochemical properties establishing their quality as a preliminary to inclusion in a dosage form. This is fundamental to monitoring and control of critical properties of these systems with a view to optimization and establishing quality by design. The use of statistical experimental design during optimization and statistical process control during manufacturing allows the production of the dosage form to meet the target product profile within narrow limits that assure its uniformity. Ultimately, assuring the quality translates into a safe and efficacious drug product.
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Hickey, A.J., Giovagnoli, S. (2018). Quality by Design for Particulate Systems. In: Pharmaceutical Powder and Particles. AAPS Introductions in the Pharmaceutical Sciences. Springer, Cham. https://doi.org/10.1007/978-3-319-91220-2_11
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DOI: https://doi.org/10.1007/978-3-319-91220-2_11
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