Abstract
Monitoring and control of complex processes involve a number of variables whose interactions are necessarily complex. Unlike many other areas of pharmaceutical development, this has long been recognized by process engineers who have the task of guaranteeing the quality and performance of the product. A variety of statistical, physical, and mathematical approaches have been adopted depending on the needs of the assessment. As tools for this purpose have evolved from the ability to manage and store data, the concept of quality by design (QbD) has gained ground and is now a central theme for industry and government regulators. QbD requires significant preparatory consideration of any process by a team of qualified individuals to map out all of the known variables that might contribute to desired attributes of the product. Since there are many variables involved in manufacturing processes and some may not be known, or not subject to control, the mathematical approach to the complexity has included artificial neural networks which have the capacity to learn from data generated and to integrate that knowledge into a predictive approach to a range of activities from research to development. Indeed, advanced mathematical modeling and control tools will be needed as the industry slowly moves from batch to continuous processing.
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References
Agatanovic-Kustrin, S., & Berseford, R. (2000). Basic concepts of artificial neural network (ANN) modeling and its application to pharmaceutical research. Journal of Pharmaceutical and Biomedical Analysis, 22, 717–727.
Achanta, A. S., Kowalski, J. G., & Rhodes, C. T. (1995). Artificial neural networks: Implications for pharmaceutical sciences. Drug Development and Industrial Pharmacy, 21, 119–155.
Borquin, J. (1997). Basic concepts of artificial neural networks (ANN) modeling in the application to pharmaceutical development. Pharmaceutical Development and Technology, 2, 95–109.
Box, G. E. P., Hunter, W. G., & Hunter, J. S. (1978). Statistics for experimenters: An introduction to design, data analysis, and model building. New York, NY: John Wiley and Sons.
Brunaugh, A., & Smyth, H. D. C. (2018). Process optimization and particle engineering of micronized drug powders via milling. Drug Delivery and Translational Research, 8(6), 1740–1750.
Cochran, W. G., & Cox, G. M. (1957). Experimental designs (2nd ed.). New York, NY: John Wiley and Sons.
Hickey, A. J., & Ganderton, D. (2010). Pharmaceutical process engineering (2nd ed.). New York, NY: Informa Healthcare.
Lepore, J., & Spavins, J. (2008). PQLI design space. Journal of Pharmaceutical Innovation, 3, 79–87.
Nosal, R., & Schultz, T. (2008). PQLI definition of criticality. Journal of Pharmaceutical Innovation, 3, 69–78.
Takayama, K., Fujikawa, M., & Nagai, T. (1999). Artificial neural network (ANN) as a novel method to optimize pharmaceutical formulation. Pharmaceutical Research, 16, 1–6.
Yu, L. X. (2008). Pharmaceutical quality by design: Product and process development, understanding, and control. Pharmaceutical Research, 25(4), 781–791.
Yu, L. X., Amidon, G., Khan, M. A., Hoag, S. W., Polli, J., Raju, G. K., et al. (2014). Understanding pharmaceutical quality by design. The AAPS Journal, 16, 771–783.
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Hickey, A.J., Smyth, H.D.C. (2020). Considerations in Monitoring and Controlling Pharmaceutical Manufacturing. In: Pharmaco-complexity. AAPS Introductions in the Pharmaceutical Sciences. Springer, Cham. https://doi.org/10.1007/978-3-030-42783-2_4
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DOI: https://doi.org/10.1007/978-3-030-42783-2_4
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