This work discusses the necessary considerations and advantages when a model-based specification is considered for the particle size distribution of the API and how this compares to common practices involving discrete points of the size distribution (such as D, D, D).
Our discussion is centered on the need of a structural specification for the API particle size that can be effectively used to guide the design of the last stages of the drug substance manufacturing train. We also emphasize the need to standardize the descriptors of particle size in order to link the effects of the variability in the API process as it affects the drug product train and eventually the quality of the dosage form.
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