The interprocess NIR sampling as an alternative approach to multivariate statistical process control for identifying sources of product-quality variability
Author:
Affiliation:
1. Lek Pharmaceuticals, d.d., Sandoz Development Center Slovenia, Ljubljana, Slovenia;
2. Faculty of Pharmacy, University of Ljubljana, Ljubljana, Slovenia;
3. Lek Pharmaceuticals, d.d., Sandoz Biopharmaceuticals, Mengeš, Slovenia
Publisher
Informa UK Limited
Subject
Organic Chemistry,Drug Discovery,Pharmaceutical Science,Pharmacology
Link
https://www.tandfonline.com/doi/pdf/10.1080/03639045.2016.1253729
Reference34 articles.
1. Process analytical technology case study part I: Feasibility studies for quantitative near-infrared method development
2. Process analytical technology case study: Part II. Development and validation of quantitative near-infrared calibrations in support of a process analytical technology application for real-time release
3. Process analytical technology case study, part III: Calibration monitoring and transfer
4. Quantitative Analysis of Film Coating in a Fluidized Bed Process by In-Line NIR Spectrometry and Multivariate Batch Calibration
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