Chapter Book (1-5 of 5)

1. Theory of Sampling (TOS): A necessary and sufficient guarantee for reliable multivariate dara analysis in pharmaceutical manufacturing

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   09 Jun 2023 | Contributor(s):: Esbensen, Kim H, Romañach, Rodolfo, J.Ferrerira, Ana P., Menezes, Jose C., Tobyn, Mike, Román-Ospino, Andrés D.

   Multivariate Analysis in the Pharmaceutical Industry provides industry practitioners with guidance on multivariate data methods and their applications over the lifecycle of a pharmaceutical product, from process development, to routine manufacturing, focusing on the challenges specific to each...

2. Near-Infrared Spectroscopy as Process Analytical Technology in Continuous Solid Dosage Form Manufacturing

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   09 Jun 2023 | Contributor(s):: Peeters, M., De Beer, T., Narang, Ajit S., Dubey, Atul., Kumar, A

   In this chapter titled “Near-infrared Spectroscopy as Process Analytical Technology in Continuous Solid Dosage Form Manufacturing” the fundamentals of near-infrared spectroscopy (NIRS) and the mainstream and emerging NIRS analyzer technologies for process analytical technology (PAT) applications...

3. Introduction to the Theory and Practice of Sampling

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   09 Jun 2023 | Contributor(s):: Esbensen, Kim H

   Sampling is an important, but sometimes hidden, part of everyday life in science, technology, industry, society and commerce where decisions are made based on analytical results, which must be based on reliable samples. However, there is a very long and complex pathway from heterogeneous...

4. Characterization of material properties

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   09 Jun 2023 | Contributor(s):: Razavi, Sonia, Oka, Sarang, Escotet-Espinoza, M. Sebastian, Wang, Yifan, Li, Tianyi, Futran Mauricio., Muzzio, Fernando

   This chapter describes the importance of deepening our understanding of material properties and their effect on process performance. There are many measurement techniques to describe the complex nature of powders, some of which are provided in this chapter. Strong knowledge of multivariate...

5. A Framework for Representative Sampling for NIR Analysis – Theory of Sampling (TOS)

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   09 Jun 2023 | Contributor(s):: Esbensen, Kim H, Ciurczak, Emil W., Igne, Benoît, Workman, Jr.,Jerome, Burns, Donald A., Romañach, Rodolfo J.

   This chapter deals with all critical steps before near-infrared spectroscopy (NIR) analysis, irrespective of whether the total sampling error contribution is large, intermediate, or small – all cases can be treated identically, including the widespread sensor-based solutions from the...