Recommended Best Practices for Lyophilization Validation 2021 Part II: Process Qualification and Continued Process Verification
Jameel, Feroz, Alexeenko, Alina, Bhambhani, Akhilesh, Sacha, Gregory, Zhu, Tong, Tchessalov, Serguei, Sharma, Puneet, Moussa, Ehab, Iyer, Lavanya, Luthra, Sumit, Srinivasan, Jayasree, Tharp, Ted, Azzarella, Joseph, Kazarin, Petr, Jalal, Mehfouz
Published in AAPS PharmSciTech (08.11.2021)
Published in AAPS PharmSciTech (08.11.2021)
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Journal Article
Recommended Best Practices for Lyophilization Validation—2021 Part I: Process Design and Modeling
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
Published in AAPS PharmSciTech (18.08.2021)
Published in AAPS PharmSciTech (18.08.2021)
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Journal Article
Best Practices and Guidelines (2022) for Scale-Up and Tech Transfer in Freeze-Drying Based on Case Studies. Part 1: Challenges during Scale Up and Transfer
Tchessalov, Serguei, Shalaev, Evgenyi, Bhatnagar, Bakul, Nail, Steven, Alexeenko, Alina, Jameel, Feroz, Srinivasan, Jayasree, Dekner, Michael, Sahni, Ekneet, Schneid, Stefan, Kazarin, Petr, McGarvey, Orla, Van Meervenne, Bert, Kshirsagar, Vaibhav, Pande, Paritosh, Philipp, Jens, Sacha, Greg, Wu, Ke, Azzarella, Joseph, Shivkumar, Gayathri, Bhatt, Shreyas
Published in AAPS PharmSciTech (30.11.2022)
Published in AAPS PharmSciTech (30.11.2022)
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Journal Article
Best Practices and Guidelines (2022) for Scale-up and Technology Transfer in Freeze Drying Based on Case Studies. Part 2: Past Practices, Current Best Practices, and Recommendations
Tchessalov, Serguei, Shalaev, Evgenyi, Bhatnagar, Bakul, Nail, Steven, Alexeenko, Alina, Jameel, Feroz, Srinivasan, Jayasree, Dekner, Michael, Sahni, Ekneet, Schneid, Stefan, Kazarin, Petr, McGarvey, Orla, Van Meervenne, Bert, Kshirsagar, Vaibhav, Pande, Paritosh, Philipp, Jens, Sacha, Greg, Wu, Ke, Azzarella, Joseph, Shivkumar, Gayathri, Bhatt, Shreyas, Mehta, Shyam B.
Published in AAPS PharmSciTech (03.04.2023)
Published in AAPS PharmSciTech (03.04.2023)
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Journal Article
Recommended Best Practices in Freeze Dryer Equipment Performance Qualification: 2022
Ganguly, Arnab, Hardwick, Lisa, Tchessalov, Serguei, Nail, Steven L., Dixon, Dan, Kanka, Frank, Guidinas, Anthony, Thompson, T. N., Reiter, Cindy, Yusoff, Zakaria, Tharp, Ted, Azzarella, Joseph, Sharma, Prerona, Kazarin, Petr, Alexeenko, Alina, Pikal, Michael J.
Published in AAPS PharmSciTech (26.01.2023)
Published in AAPS PharmSciTech (26.01.2023)
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Journal Article
Correction to: Recommended Best Practices for Lyophilization Validation—2021 Part I: Process Design and Modeling
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
Published in AAPS PharmSciTech (18.10.2021)
Published in AAPS PharmSciTech (18.10.2021)
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Journal Article