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Process Scale-Up and Optimization of Lyophilized Vaccine Products

  • Blue J
  • Sinacola J
  • Bhambhani A
Springer New York, (2015), 179-210
DOI: 10.1007/978-1-4939-2383-0_9
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Abstract

… One example would be the licensing of RotaTeq®, where the efficacy study consisted of approximate 5700 patients and the phase III trial consisted of ~ 71,000 patients [1, 2]. The overall timeline for the phase III clinical trial (REST study) took more than 4 years to complete …

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Blue, J. T., Sinacola, J. R., & Bhambhani, A. (2015). Process Scale-Up and Optimization of Lyophilized Vaccine Products. In Lyophilized Biologics and Vaccines (pp. 179–210). Springer New York. https://doi.org/10.1007/978-1-4939-2383-0_9

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