References
- Altan, S., D. Banton, H. Coppenolle, M. Kovarik, and M. Otava. 2022. A Bayesian approach to multivariate conditional regression surrogate modeling with application to real time release testing. Chapter 9. In Case studies in Bayesian methods for biopharmaceutical CMC, ed. P. Faya, and T. Pourmohamad, Boca Raton, FL: CRC Press.
- FDA. 2004. Guidance for industry PAT—A framework for innovative pharmaceutical development, manufacturing, and quality assurance.
- FDA. 2007. Pharmaceutical CGMP initiative for the 21st century – a risk based approach. https://www.fda.gov/about-fda/center-drug-evaluation-and-research-cder/pharmaceutical-quality-21st-century-risk-based-approach-progress-report
- FDA. 2022. An FDA self-audit of continuous manufacturing for drug products. https://www.fda.gov/drugs/cder-small-business-industry-assistance-sbia/fda-self-audit-continuous-manufacturing-drug-products-audio-transcript
- Hare, L., R. Does, R. Hoerl, and R. Snee. 2021. Statistical engineering handbook. www.isea-change.org
- Hoerl, R. 2021. Statistical engineering: An idea whose time has come. DATAWorks Conference, April 12, 2021.
- Hoerl, R., and R. Snee. 2017. Statistical engineering: An idea whose time has come. The American Statistician 71 (3):209–19. doi:10.1080/00031305.2016.1247015.
- Peterson, J. J. 2008. A Bayesian approach to the ICH Q8 definition of design space. Journal of Biopharmaceutical Statistics 18:958–9748. doi:10.1080/10543400802278197.
- Shi, Z., S. Altan, D. Banton, S. Nielsen, M. Otava, A. Garrett, and M. Wallworth. 2022. Predictive In-vitro dissolution for real-time release test (RTRT) for continuous manufacturing process on drug product, Chapter 7. In Continuous pharmaceutical processing and process analytical technology, ed. S. Ajit and A. D. Narang. Boca Raton, FL: CRC Press.
- Vining, G. 2021. Statistical engineering: A glimpse into the future. https://isea-change.org/resources/Documents/Statistical%20Engineering%20-%20Glimpse%20into%20the%20Future.pdf
- Woodcock, J. 2004. The concepts of pharmaceutical quality. American Pharmaceutical Review 7:10–5.
- Woodcock, J. 2014. Modernizing pharmaceutical manufacturing – Continuous manufacturing as a key enabler. MIT-CMAC International Symposium on Continuous Manufacturing of Pharmaceuticals, Cambridge, MA.
- Woodcock, J., and R. Woosley. 2008. The FDA critical path initiative and its influence on new drug development. Annual Review of Medicine 59:1–12. doi:10.1146/annurev.med.59.090506.155819. PMID: 18186700.