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1. The Process Analytical Technology Initiative: PAT and the Pharmacopeias

   out of 5 stars 

   | Contributor(s):: Ajaz S. Hussain

   The PAT Initiative A part of the Pharmaceutical Quality for the 21st Century Initiative  PAT and the USP Opportunities for the USP to support the PAT Framework

2. Model predictive in vitro dissolution testing in pharmaceutical continuous manufacturing: An equivalence study

   out of 5 stars 

   | Contributor(s):: Atul Dubey, Su Qinglin, Paul Hermant, Federica Casati, Bhakti Halkude, Wei Wu, Anjana Ramnath, Stephen Born, Salvatore Mascia, Bayan Takizawa

   A predictive mathematical model for tablet dissolution was developed and implemented in an end-to-end integrated continuous manufacturing pilot plant. The tablets were produced for immediate release with a proprietary extrusion-molding-coating (EMC) unit operation. Besides the mass balance of...

3. Enabling real time release testing by NIR prediction of dissolution of tablets made by continuous direct compression (CDC)

   out of 5 stars 

   | Contributor(s):: Pawar, Pallavi, Wang, Yifan, Keyvan, Golshid, Callegari, Gerardo, Cuitino, Alberto, Muzzio, Fernando

   A method for predicting dissolution profiles of directly compressed tablets for a fixed sustained release formulation manufactured in a continuous direct compaction (CDC) system is presented. The methodology enables real-time release testing (RTRt). Tablets were made at a target drug...