Integrating QbD Tools for Flexible Scale-Up Batch Size Selection for Solid Dosage Forms

The pilot scale batch size for solid oral dosage forms is currently defined by major regulatory agencies as one-tenth of the full production, or 100,000 units, whichever is larger. The current criterion is arbitrary and is not based on scientific and risk assessment principles. The approach does not...

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Veröffentlicht in:	Journal of pharmaceutical sciences 2020-03, Vol.109 (3), p.1223-1230
Hauptverfasser:	Charoo, Naseem A., Rahman, Ziyaur
Format:	Artikel
Sprache:	eng
Schlagworte:	dimensionless numbers pilot batch process analytical technology quality by design scale up simulators solid dosage forms
Online-Zugang:	Volltext
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