Výsledky vyhledávání - "Michael J. Pikal"

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

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Applications of the Tunable Diode Laser Absorption Spectroscopy: In-Process Estimation of Primary Drying Heterogeneity and Product Temperature During Lyophilization

Autor: Robin H. Bogner, William J. Kessler, Michael J. Pikal, Puneet Sharma, Meena Thakur

Publikováno v: Journal of Pharmaceutical Sciences. 108:416-430

The aim of this research was to evaluate the impact of variability in ice sublimation rate (dm/dt) measurement and vial heat transfer coefficient (Kv) on product temperature prediction during the primary drying phase of lyophilization. The mathematic

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::0ec0cba631aaa008bba69081432f2ec3
https://doi.org/10.1016/j.xphs.2018.07.031

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Evaluation of Predictors of Protein Relative Stability Obtained by Solid-State Hydrogen/Deuterium Exchange Monitored by FTIR

Autor: Robin H. Bogner, Michael J. Pikal, Rui Fang, Wasfy M. Obeidat

Publikováno v: Pharmaceutical Research. 37

Hydrogen/deuterium (H/D) exchange over a range of temperatures suggests a protein structural/mobility transition in the solid state below the system glass transition temperature (Tg). The purpose of this study was to determine whether solid-state pro

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_________::73f3ee02ab86835e18ef1a00c1cebd67
https://doi.org/10.1007/s11095-020-02897-7

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Impact of Natural Variations in Freeze-Drying Parameters on Product Temperature History: Application of Quasi Steady-State Heat and Mass Transfer and Simple Statistics

Autor: Robin H. Bogner, Michael J. Pikal, Vamsi K. Mudhivarthi, Paritosh Pande, Puneet Sharma, Pooja Sane

Publikováno v: AAPS PharmSciTech. 19:2828-2842

Inter- and intra-batch variability in heat and mass transfer during the drying phase of lyophilization is well recognized. Heat transfer variability between individual vials in the same batch arise from both different positions in the vial array and

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::7f53e78992d7e9e4f0ee018ced34fde4
https://doi.org/10.1208/s12249-018-1155-4

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Evaluation of Predictors of Protein Relative Stability Obtained by Solid-State Hydrogen/Deuterium Exchange Monitored by FTIR

Autor: Rui, Fang, Wasfy, Obeidat, Michael J, Pikal, Robin H, Bogner

Publikováno v: Pharmaceutical research. 37(9)

Hydrogen/deuterium (H/D) exchange over a range of temperatures suggests a protein structural/mobility transition in the solid state below the system glass transition temperature (TSolid-state H/D exchange was monitored by FTIR spectroscopy to study t

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=pmid________::f696727960b69bbd9be02ca021725939
https://pubmed.ncbi.nlm.nih.gov/33595824

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Development of a Mini-Freeze Dryer for Material-Sparing Laboratory Processing with Representative Product Temperature History

Autor: William J. Kessler, Wasfy M. Obeidat, Michael J. Pikal, Ekneet Kaur Sahni

Publikováno v: AAPS PharmSciTech. 19:599-609

The goal of the work described in this publication was to evaluate a new, small, material-sparing freeze dryer, denoted as the “mini-freeze dryer or mini-FD”, capable of reproducing the product temperature history of larger freeze dryers, thereby

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::1f75a922c698aa8af206a0cb078ca69b
https://doi.org/10.1208/s12249-017-0871-5

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Modeling the Secondary Drying Stage of Freeze Drying: Development and Validation of an Excel-Based Model

Autor: Ekneet Sahni, Michael J. Pikal

Publikováno v: Journal of Pharmaceutical Sciences. 106:779-791

Although several mathematical models of primary drying have been developed over the years, with significant impact on the efficiency of process design, models of secondary drying have been confined to highly complex models. The simple-to-use Excel-ba

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::3d95e7a8c3a5b8677d0194955e1f4bad
https://doi.org/10.1016/j.xphs.2016.10.024

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