Abstract
Processes ready for commercialization post Stage 1A need to demonstrate capability for commercial scaling. Commercial scale-up studies are conducted as part of Stage 1B process design activities. The manufacturing process is evaluated to estimate effect of scale. Product control strategy is optimized post Stage 1B studies. The successful completion of the stage ensures readiness for process performance qualification.
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© 2018 American Association of Pharmaceutical Scientists
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Pazhayattil, A.B., Sayeed-Desta, N., Fredro-Kumbaradzi, E., Collins, J. (2018). Stage 1B Process Scale-Up Considerations. In: Solid Oral Dose Process Validation. AAPS Introductions in the Pharmaceutical Sciences. Springer, Cham. https://doi.org/10.1007/978-3-030-02472-7_5
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DOI: https://doi.org/10.1007/978-3-030-02472-7_5
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Publisher Name: Springer, Cham
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Online ISBN: 978-3-030-02472-7
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