Multivariate Analysis in the Pharmaceutical Industry

<p>Section I. Background and Methodology<br>1. The pre-eminence of multivariate data analysis as a statistical data analysis technique in pharmaceutical R&D and manufacturing<br>2. The philosophy and fundamentals of handling, modeling and interpreting large data sets - the multivariate chemometrics approach<br>3. Data processing in multivariate analysis of pharmaceutical processes<br>4. Theory of sampling (TOS) – a necessary and sufficient guarantee for reliable multivariate data analysis in pharmaceutical manufacturing <br>5. The ‘how’ of multivariate analysis (MVA) in the pharmaceutical industry: A holistic approach<br>6. Quality by design in practice</p> <p>Section II. Applications in Pharmaceutical Development and Manufacturing<br>7. Multivariate analysis supporting pharmaceutical research <br>8. Multivariate data analysis for enhancing process understanding, monitoring and control – active pharmaceutical ingredient manufacturing case studies<br>9. Applications of MVDA and PAT for drug product development and manufacturing<br>10. Applications of multivariate analysis to monitor and predict pharmaceutical materials properties<br>11. Mining information from developmental data: process understanding, design space identification, and product transfer<br>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<br>13. Model maintenance<br>14. Lifecycle management of PAT procedures: Applications to batch and continuous processes<br>15. Applications of MVA for product quality management: Continued process verification and continuous improvement  <br>16. The role of multivariate statistical process control in the pharma industry<br>17. Application of multivariate process modelling for monitoring and control applications in continuous pharmaceutical manufacturing</p> <p>Section III. Guidance Documents and Regulatory Framework<br>18. Guidance for compendial use – The USP <1039> chapter<br>19. Multivariate analysis and the pharmaceutical regulatory framework</p>