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.

1. Applications of Modeling in Oral Solid Dosage Form Development and Manufacturing

            Olav Lyngberg, Lieve Bijnens, Jeroen Geens, Alex Marchut, Steve Mehrman, and Elisabeth Schafer

2. Population Balance Models for Pharmaceutical Processes

            Anwesha Chaudhury, Maitraye Sen, Dana Barrasso, and Rohit Ramachandran

3. A Quantitative Approach to Understand Raw Material Variability

            Sara Koynov and Fernando Muzzio

4. Discrete Element Modeling of Solid Dosage Manufacturing Processes

            Dana Barrasso and Rohit Ramachandran

5. A Procedure for Developing Quantitative Near Infrared (NIR) Methods for Pharmaceutical Products

            Rodolfo J. Romañach, Andres Román Ospino, and Manel Alcalà

6. Advanced Process Decision Making Using Multivariate Latent Variable Methods

            Matteo Ottavian, Emanuele Tomba, and Massimiliano Barolo

7. Advanced Control of Continuous Pharmaceutical Tablet Manufacturing Processes

            Ravendra Singh, Carlos Velazquez, Abhishek Sahay, Krizia M. Karry, Fernando Muzzio, Marianthi Ierapetritou, and Rohit Ramachandran

8. Mathematical Tools for the Quantitative Definition of a Design Space

            Amanda Rogers and Marianthi G. Ierapetritou

9. Optimization Methodologies for the Production of Pharmaceutical Products

            M. Sebastian Escotet-Espinoza, Amanda Rogers, and Marianthi G. Ierapetritou

10. An Overview of Pharmaceutical Manufacturing for Solid Dosage Forms

            Stephan Sacher and Johannes G. Khinast