MULTIVARIATE ANALYSIS IN THE PHARMACEUTICAL INDUSTRY

Section I. Background and Methodology
1. The pre-eminence of multivariate data analysis as a statistical data analysis technique in pharmaceutical R&D and manufacturing
2. The philosophy and fundamentals of handling, modeling and interpreting large data sets - the multivariate chemometrics approach
3. Data processing in multivariate analysis of pharmaceutical processes
4. Theory of sampling (TOS) – a necessary and sufficient guarantee for reliable multivariate data analysis in pharmaceutical manufacturing
5. The ‘how’ of multivariate analysis (MVA) in the pharmaceutical industry: A holistic approach
6. Quality by design in practice

Section II. Applications in Pharmaceutical Development and Manufacturing
7. Multivariate analysis supporting pharmaceutical research
8. Multivariate data analysis for enhancing process understanding, monitoring and control – active pharmaceutical ingredient manufacturing case studies
9. Applications of MVDA and PAT for drug product development and manufacturing
10. Applications of multivariate analysis to monitor and predict pharmaceutical materials properties
11. Mining information from developmental data: process understanding, design space identification, and product transfer
12. A systematic approach to process data analytics in pharmaceutical manufacturing: The data analytics triangle and its application to the manufacturing of a monoclonal antibody
13. Model maintenance
14. Lifecycle management of PAT procedures: Applications to batch and continuous processes
15. Applications of MVA for product quality management: Continued process verification and continuous improvement
16. The role of multivariate statistical process control in the pharma industry
17. Application of multivariate process modelling for monitoring and control applications in continuous pharmaceutical manufacturing

Section III. Guidance Documents and Regulatory Framework
18. Guidance for compendial use – The USP <1039> chapter
19. Multivariate analysis and the pharmaceutical regulatory framework

• Targets pharmaceutical industry practitioners and regulatory staff by addressing industry specific challenges
• Includes case studies from different pharmaceutical companies and across product lifecycle of to introduce readers to the breadth of applications
• Contains information on the current regulatory framework which will shape how multivariate analysis (MVA) is used in years to come

Author
• Ana Patricia Ferreira, Principal Scientist, Department of Drug Product Science and Technology, Bristol-Myers Squibb, Moreton, UK ;
• Jose C. Menezes, Associate Professor, University of Lisbon, Faculty of Pharmacy, Program Director, Pharmaceutical Engineering Master’s Program, Technical University of Lisbon, Lisbon, Portugal
• Mike Tobyn, Research Fellow, Department of Drug Product Science and Technology, Bristol-Myers Squibb, Moreton, UK