Implementation of a fully integrated CM direct compression and coating process at a commercial pharmaceutical facility - Part 2: PAT and RTD results for normal operational conditions batches.
暂无分享,去创建一个
J. G. Rosas | M. Ramasamy | S. Hurley | S. Conway | Bruce Thompson | Daria Stoliarskaia | Paul Overton | Neil Tugby | P. Brush | Charles Miller
[1] M. Metzger,et al. Development and Use of a Residence Time Distribution (RTD) Model Control Strategy for a Continuous Manufacturing Drug Product Pharmaceutical Process , 2022, Pharmaceutics.
[2] J. Wahlich. Review: Continuous Manufacturing of Small Molecule Solid Oral Dosage Forms , 2021, Pharmaceutics.
[3] Robert Meyer,et al. A very boring 120 h: 15 million tablets under a continuous state of control , 2021 .
[4] V. Vanhoorne,et al. Recent progress in continuous manufacturing of oral solid dosage forms. , 2020, International journal of pharmaceutics.
[5] Indrajeetsinh K. Yadav,et al. Mapping key process parameters to the performance of a continuous dry powder blender in a continuous direct compression system , 2020 .
[6] R. T. Haslam,et al. Why We Need Continuous Pharmaceutical Manufacturing and How to Make it Happen: A Summary of Thoughts from the International Symposium on Continuous Manufacturing. , 2019, Journal of pharmaceutical sciences.
[7] V. Vanhoorne,et al. Evaluation of an in-line NIR spectroscopic method for the determination of the residence time in a tablet press. , 2019, International journal of pharmaceutics.
[8] Rafael Méndez,et al. Assessment of blend uniformity in a continuous tablet manufacturing process , 2019, International journal of pharmaceutics.
[9] Victoria Pauli,et al. Process analytical technology for continuous manufacturing tableting processing: A case study , 2019, Journal of pharmaceutical and biomedical analysis.
[10] Eric Ziemons,et al. Development and validation of an in‐line NIR spectroscopic method for continuous blend potency determination in the feed frame of a tablet press , 2018, Journal of pharmaceutical and biomedical analysis.
[11] Jenny M. Vargas,et al. Process analytical technology in continuous manufacturing of a commercial pharmaceutical product. , 2018, International journal of pharmaceutics.
[12] Salvador García-Muñoz,et al. A flowsheet model for the development of a continuous process for pharmaceutical tablets: An industrial perspective , 2018 .
[13] Debasis Mallik,et al. Process Analytical Tools for Flow Analysis: A Perspective , 2017, Journal of Flow Chemistry.
[14] Bernhardt L Trout,et al. Regulatory Perspectives on Continuous Pharmaceutical Manufacturing: Moving From Theory to Practice: September 26-27, 2016, International Symposium on the Continuous Manufacturing of Pharmaceuticals. , 2017, Journal of pharmaceutical sciences.
[15] C Vervaet,et al. Development of a continuous direct compression platform for low-dose drug products. , 2017, International journal of pharmaceutics.
[16] Karthik Nagapudi,et al. Control Strategies for Drug Product Continuous Direct Compression-State of Control, Product Collection Strategies, and Startup/Shutdown Operations for the Production of Clinical Trial Materials and Commercial Products. , 2017, Journal of pharmaceutical sciences.
[17] C Vervaet,et al. Continuous direct compression as manufacturing platform for sustained release tablets. , 2017, International journal of pharmaceutics.
[18] Eric Sanchez,et al. Evaluation of Analytical and Sampling Errors in the Prediction of the Active Pharmaceutical Ingredient Concentration in Blends From a Continuous Manufacturing Process , 2017, Journal of Pharmaceutical Innovation.
[19] Zhenqi Shi,et al. On-line monitoring of blend uniformity in continuous drug product manufacturing process--The impact of powder flow rate and the choice of spectrometer: Dispersive vs. FT. , 2016, Journal of pharmaceutical and biomedical analysis.
[20] Fernando J. Muzzio,et al. Development of a methodology to estimate error in the on-line measurements of blend uniformity in a continuous powder mixing process , 2013 .
[21] Mikko Juuti,et al. In-line monitoring of the drug content of powder mixtures and tablets by near-infrared spectroscopy during the continuous direct compression tableting process. , 2013, European journal of pharmaceutical sciences : official journal of the European Federation for Pharmaceutical Sciences.
[22] Aditya U. Vanarase,et al. Real-time monitoring of drug concentration in a continuous powder mixing process using NIR spectroscopy , 2010 .
[23] Stefan Andersson-Engels,et al. Time-Resolved NIR/Vis Spectroscopy for Analysis of Solids: Pharmaceutical Tablets , 2002 .
[24] J. Fricke,et al. Effective Sample Size in Diffuse Reflectance Near-IR Spectrometry. , 1999, Analytical chemistry.
[25] P. K. Aldridge,et al. Automated system for the on-line monitoring of powder blending processes using near-infrared spectroscopy. Part I. System development and control. , 1996, Journal of pharmaceutical and biomedical analysis.
[26] P. K. Aldridge,et al. On-line monitoring of powder blend homogeneity by near-infrared spectroscopy. , 1996, Analytical chemistry.
[27] Lloyd S. Nelson,et al. Column: Technical Aids: The Shewhart Control Chart--Tests for Special Causes , 1984 .
[28] A. T. McKay,et al. Distribution of the Coefficient of Variation and the Extended “T” Distribution , 1932 .