Lyophilization Validation: Process Design and Modeling-Reference-Cited by-同舟云学术

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Lyophilization Validation: Process Design and Modeling

Published:2023 Issue: Volume: Page:489-511
ISSN:2210-7371
Container-title:Principles and Practices of Lyophilization in Product Development and Manufacturing
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Author:

Jameel Feroz,Alexeenko Alina,Bhambhani Akhilesh,Sacha Gregory,Zhu Tong,Tchessalov Serguei,Kumar Lokesh,Sharma Puneet,Moussa Ehab,Iyer Lavanya,Fang Rui,Srinivasan Jayasree,Tharp Ted,Azzarella Joseph,Kazarin Petr,Jalal Mehfouz

Publisher

Springer International Publishing

Link

https://link.springer.com/content/pdf/10.1007/978-3-031-12634-5_26

Reference35 articles.

1. Pikal MJ. Lyophilization. In: Swarbrick J, Boylan J, editors. Encyclopedia of pharmaceutical technology. CRC Press; 2002. p. 1299–326.

2. Carpenter JF, Pikal MJ, Chang BS, Randolph TW. Rational design of stable lyophilized protein formulations: some practical advice. Pharm Res. 1997;14:969–75.

3. Blue JT, Sinacola JR, Bhambhani A. Process scale-up and optimization of lyophilized vaccine products. In: Lyophilized biologics and vaccines. Springer; 2015. p. 179–210.

4. Tang X, Pikal MJ. Design of freeze-drying processes for pharmaceuticals: practical advice. Pharm Res. 2004;21:191–200.

5. Jennings TA. Validation of the lyophilzation process. New York: Marcel Dekker; 1986.

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