MANUFACTURE OF INDIVIDUALIZED DOSING: DEVELOPMENT AND CONTROL OF A DROPWISE ADDITIVE MANUFACTURING PROCESS FOR MELT BASED PHARMACEUTICAL PRODUCTS
Date of Award
Doctor of Philosophy (PhD)
Gintaras V Reklaitis
Zoltan K Nagy
Committee Member 1
Committee Member 2
The improvements in healthcare systems and the advent of precision medicine initiative have created the need to develop more innovative manufacturing methods for the delivery of individualized dosing and personalized treatments. In recent years, the US Food and Drug Administration (FDA) introduced the Quality by Design (QbD) and Process Analytical Technology (PAT) guidelines to encourage innovation and efficiency in pharmaceutical development, manufacturing and quality assurance. As a result of emerging technologies and encouragement from the regulatory authorities, the pharmaceutical industry has begun to develop more efficient production systems with more intensive use of on-line measurement and sensing, real time quality control and process control tools, which offer the potential for reduced variability, increased flexibility and efficiency, and improved product quality.
Icten, Elcin, "MANUFACTURE OF INDIVIDUALIZED DOSING: DEVELOPMENT AND CONTROL OF A DROPWISE ADDITIVE MANUFACTURING PROCESS FOR MELT BASED PHARMACEUTICAL PRODUCTS" (2016). Open Access Dissertations. 1289.