Process Simulation and Data Modeling in Solid Oral Drug Development and Manufacture

This thorough volume aims to provide pharmaceutical engineers with an introduction to the current state of the art in modeling and simulation of pharmaceutical processes and to summarize a number of practical applications of relevant methodologies in drug product development. Chapters include explorations of simulation and modeling methodologies, data collection and analysis, development of novel sensing techniques, development and integration of individual unit models, optimization approaches for data-based models, design space evaluation techniques, informatics-based methodologies, and emerging topics in pharmaceutical process development. As a part of the Methods in Pharmacology and Toxicology series, the chapters contain the kind of detail and implementation advice that will make the transition into the laboratory as smooth as possible.

Authoritative and cutting edge, Process Simulation and Data Modeling in Solid Oral Drug Development and Manufacture seeks to promote research into process systems methodologies and their application in pharmaceutical product and process development, which will undoubtedly become an increasingly important area in the future.

Provides a practical introduction to the current state of the art in modeling and simulation of pharmaceutical processes Explores methodologies in drug product development Features expert tips and implementation advice for application in the lab Includes supplementary material: sn.pub/extras

Inhalt

Applications of Modeling in Oral Solid Dosage Form Development and Manufacturing.- Population Balance Models for Pharmaceutical Processes.- A Quantitative Approach to Understand Raw Material Variability.- Discrete Element Modeling of Solid Dosage Manufacturing Processes.- A Procedure for Developing Quantitative Near Infrared (NIR) Methods for Pharmaceutical Products.- Advanced Process Decision Making Using Multivariate Latent Variable Methods.- Advanced Control of Continuous Pharmaceutical Tablet Manufacturing Processes.- Mathematical Tools for the Quantitative Definition of a Design Space.- Optimization Methodologies for the Production of Pharmaceutical Products.- An Overview of Pharmaceutical Manufacturing for Solid Dosage Forms.