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The Special Issue on "Model-Based Tools for Pharmaceutical Manufacturing Processes" will curate novel advances in the development and application of model-based tools to address ever-present challenges of the traditional pharmaceutical manufacturing practice as well as new trends. This book provides a collection of nine papers on original advances in the model-based process unit, system-level, quality-by-design under uncertainty, and decision-making applications of pharmaceutical manufacturing processes.
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CADTH found that the sponsor's base case included several assumptions that were favourable to recombinant von Willebrand factor (rVWF) but that were not supported by clinical evidence. There is currently no head-to-head clinical trial comparing rVWF with plasma-induced von Willebrand factor (VWF). CADTH undertook reanalyses to address this limitation by implementing identical settings for the efficacy, safety, and resource utilization of rVWF, with or without recombinant factor VIII (rFVIII), and antihemophilic factor/VWF complex. Where only blood product acquisition cost was considered, CADTH found that rVWF, with or without rFVIII, was 4,514 and 19,240 more costly than antihemophilic factor/VWF complex for on-demand bleeding episodes and for perioperative management, respectively. It was more expensive primarily due to the higher unit cost of rVWF 1.54 per IU versus 0.92 per IU and due to the additional cost of potential co-administration with rFVIII. A price reduction of 40% is required for rVWF to have a treatment acquisition cost similar to that of antihemophilic factor/VWF complex. However, an even greater price reduction would be required if the actual cost of plasma-derived VWF were lower than the assumed price (0.92 per IU), if the price of rFVIII were higher than the assumed price 0.82 per IU, and/or if a greater proportion of patients required rFVIII dosed concomitantly with rVWF.
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