selected publications
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academic article
- Method transfer of a near-infrared spectroscopic method for blend uniformity in a poorly flowing and hygroscopic blend. Journal of Pharmaceutical & Biomedical Analysis. 180. 2020
- Assessment of blend uniformity in a continuous tablet manufacturing process. International Journal of Pharmaceutics. 560:322-333. 2019
- Development of near infrared spectroscopic calibration models for in-line determination of low drug concentration, bulk density, and relative specific void volume within a feed frame. J. Pharm. Biomed. Anal. . 164:211-222. 2019
- Evaluation of Analytical and Sampling Errors in the Prediction of the Active Pharmaceutical Ingredient Concentration in Blends From a Continuous Manufacturing Process. Journal of Pharmaceutical Innovation. 12:155-167. 2017
- Adequacy and verifiability of pharmaceutical mixtures and dose units by variographic analysis (Theory of Sampling) – A call for a regulatory paradigm shift.. International Journal of Pharmaceutics. 499:156-174. 2016
- Near infrared spectroscopic calibration models for real time monitoring of powder density. International Journal of Pharmaceutics. 512:61-74. 2016
- Near infrared spectroscopic transmittance measurements for pharmaceutical powder mixtures. Journal of Pharmaceutical & Biomedical Analysis. 123:120-127. 2016
- Estimating total sampling error for near infrared spectroscopic analysis of pharmaceutical blends—theory of sampling to the rescue. TOS Forum. 5:71-75. 2015
- Real time monitoring of powder blend bulk density for coupled feed-forward/feed-back control of a continuous direct compaction tablet manufacturing process. International Journal of Pharmaceutics. 495:612-625. 2015
- When “homogeneity” is expected—Theory of Sampling in pharmaceutical manufacturing. TOS Forum. 5:67-70. 2015
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chapter
- Theory of Sampling (TOS): A Necessary and Sufficient Guarantee for Reliable Multivariate Data Analysis in Pharmaceutical Manufacturing. Multivariate Analysis in the Pharmaceutical Industry. Ed. Ferreira, Ana P. London, United Kingdom: Academic Press. 53-91. 2018
- A Procedure for Developing Quantitative Near Infrared (NIR) Methods for Pharmaceutical Products. Process Simulation and Data Modeling in Solid Oral Drug Development and Manufacture. Ed. Ierapetritou, Marianthi. New York: Springer. 133-158. 2015
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review