Zobrazeno 1 - 10
of 212
pro vyhledávání: '"L, Nail"'
Autor:
Arnab Ganguly, Lisa Hardwick, Serguei Tchessalov, Steven L. Nail, Dan Dixon, Frank Kanka, Anthony Guidinas, T. N. Thompson, Cindy Reiter, Zakaria Yusoff, Ted Tharp, Joseph Azzarella, Prerona Sharma, Petr Kazarin, Alina Alexeenko, Michael J. Pikal
Publikováno v:
AAPS PharmSciTech. 24
Best practices for performing freeze dryer equipment qualification are recommended, focusing on identifying methods to quantify shelf thermal uniformity (also known as “shelf surface uniformity”), equipment capability, and performance metrics of
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_________::d9cec8a868a4a99f24c1c87e0a37fb8a
https://doi.org/10.1208/s12249-023-02506-x
https://doi.org/10.1208/s12249-023-02506-x
Autor:
Sajal Manubhai Patel, Steven L. Nail, Michael J. Pikal, Raimund Geidobler, Gerhard Winter, Andrea Hawe, Juan Davagnino, Shailaja Rambhatla Gupta
Publikováno v:
Principles and Practices of Lyophilization in Product Development and Manufacturing ISBN: 9783031126338
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_________::4211d3809f2899d01a25df035f9847eb
https://doi.org/10.1007/978-3-031-12634-5_31
https://doi.org/10.1007/978-3-031-12634-5_31
Publikováno v:
International Journal of Pharmaceutics. 630:122417
An emerging approach to process development of a lyophilized pharmaceutical product is to construct a graphical design space for primary drying as an aid to process optimization. The purpose of this paper is to further challenge the assumption in ear
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::a11fd48477e08b04caae2a3236cea9ed
https://doi.org/10.1016/j.ijpharm.2022.122417
https://doi.org/10.1016/j.ijpharm.2022.122417
Autor:
Steven L. Nail, Tong Zhu, Gregory A. Sacha, Gayathri Shivkumar, Vaibhav Kshirsagar, Israel B. Sebastião, Alina Alexeenko
Publikováno v:
Journal of Pharmaceutical Sciences. 108:2972-2981
The equipment capability curve is one of the bounding elements of the freeze-drying design space, and understanding it is critical to process design, transfer, and scale-up. The second bounding element of the design space is the product temperature l
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::50cc7cba41d5c13b0a262a0826f5f567
https://doi.org/10.1016/j.xphs.2019.04.016
https://doi.org/10.1016/j.xphs.2019.04.016
Autor:
Brendan M. Mayhugh, Elizabeth M. Topp, Eunbi Cho, Gregory A. Sacha, Jayasree M. Srinivasan, Steven L. Nail
Publikováno v:
Journal of Pharmaceutical Sciences.
Antibody drug conjugates (ADCs) have been at the forefront in cancer therapy due to their target specificity. All the FDA approved ADCs are developed in lyophilized form to minimize instability associated with the linker that connects the cytotoxic d
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::236e224940b29066e99c2f9d084c3639
https://doi.org/10.1016/j.xphs.2021.03.006
https://doi.org/10.1016/j.xphs.2021.03.006
Autor:
Gregory A. Sacha, Alina Alexeenko, Jayasree M. Srinivasan, Steven L. Nail, Vaibhav Kshirsagar
Publikováno v:
AAPS PharmSciTech
The objective of this investigation was to evaluate two methods for measuring the maximum sublimation rate that a freeze-dryer will support—the minimum controllable pressure method and the choke point method. Both methods gave equivalent results, b
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::e795451048931af401a2dddb3cb9288a
https://doi.org/10.1208/s12249-021-01921-2
https://doi.org/10.1208/s12249-021-01921-2
Experimental Aspects of Measuring the Vial Heat Transfer Coefficient in Pharmaceutical Freeze-Drying
Publikováno v:
AAPS PharmSciTech. 19:1810-1817
One of the current methods for cycle optimization in primary drying to is develop a graphical design space based on quality by design (QbD). In order to construct the design space, the vial heat transfer coefficient (Kv) is needed. This paper investi
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::02297f27c892ade770655d8a11702480
https://doi.org/10.1208/s12249-018-0998-z
https://doi.org/10.1208/s12249-018-0998-z
Autor:
Steven L. Nail, Larry A. Gatlin
Publikováno v:
Parenteral Medications ISBN: 9780429201400
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_________::f5268f9a76ffaca2da8dc75b5e14b559
https://doi.org/10.1201/9780429201400-48
https://doi.org/10.1201/9780429201400-48
Autor:
Larry A. Gatlin, Steven L. Nail
Publikováno v:
Protein Purification Process Engineering ISBN: 9780203741733
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_________::0ac3aee3a68ff98ff762e662221205e4
https://doi.org/10.1201/9780203741733-9
https://doi.org/10.1201/9780203741733-9
Autor:
Lavanya K. Iyer, Balakrishnan S. Moorthy, Gregory A. Sacha, Steven L. Nail, Elizabeth M. Topp
Publikováno v:
Journal of Pharmaceutical Sciences. 105:1684-1692
Myoglobin (Mb) was lyophilized in the absence (Mb-A) and presence (Mb-B) of sucrose in a pilot-scale lyophilizer with or without controlled ice nucleation. Cake morphology was characterized using scanning electron microscopy, and changes in protein s
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::a3f30acf01c60b338292812bda513cd2
https://doi.org/10.1016/j.xphs.2016.02.033
https://doi.org/10.1016/j.xphs.2016.02.033