Publications by authors named "Steven Nail"

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Randomized-field microwave-assisted pharmaceutical lyophilization with closed-loop control.
Alina A Alexeenko, Ahmad Darwish, Drew Strongrich, Petr Kazarin, Chanakya Patil, Steven L Nail

Sci Rep· March 2025

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Accelerated Storage for Shelf-Life Prediction of Lyophiles: Temperature Dependence of Degradation of Amorphous Small Molecular Weight Drugs and Proteins.
Evgenyi Shalaev, Satoshi Ohtake, Ehab M Moussa, Jim Searles, Steven Nail

J Pharm Sci· June 2023

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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.
Serguei Tchessalov, Evgenyi Shalaev, Bakul Bhatnagar, Steven Nail, Alina Alexeenko

AAPS PharmSciTech· April 2023

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The graphical design space for the primary drying phase of freeze Drying: Factors affecting the dried product layer resistance.
Jayasree M Srinivasan, Gregory A Sacha, Steven L Nail

Int J Pharm· January 2023

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Recommended Best Practices in Freeze Dryer Equipment Performance Qualification: 2022.
Arnab Ganguly, Lisa Hardwick, Serguei Tchessalov, Steven L Nail, Dan Dixon

AAPS PharmSciTech· January 2023

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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.
Serguei Tchessalov, Evgenyi Shalaev, Bakul Bhatnagar, Steven Nail, Alina Alexeenko

AAPS PharmSciTech· November 2022

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Stability of antibody drug conjugate formulations evaluated using solid-state hydrogen-deuterium exchange mass spectrometry.
Eunbi Cho, Brendan M Mayhugh, Jayasree M Srinivasan, Gregory A Sacha, Steven L Nail

J Pharm Sci· June 2021

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Equipment Capability Measurement of Laboratory Freeze-Dryers: a Comparison of Two Methods.
Jayasree M Srinivasan, Gregory A Sacha, Vaibhav Kshirsagar, Alina Alexeenko, Steven L Nail

AAPS PharmSciTech· January 2021

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Stability of Freeze-Dried Protein Formulations: Contributions of Ice Nucleation Temperature and Residence Time in the Freeze-Concentrate.
Rui Fang, Robin H Bogner, Steven L Nail, Michael J Pikal

J Pharm Sci· June 2020

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Freeze-Dryer Equipment Capability Limit: Comparison of Computational Modeling With Experiments at Laboratory Scale.
Gayathri Shivkumar, Vaibhav Kshirsagar, Tong Zhu, Israel B Sebastiao, Steven L Nail

J Pharm Sci· September 2019

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Experimental Aspects of Measuring the Vial Heat Transfer Coefficient in Pharmaceutical Freeze-Drying.
Lindsay A Wegiel, Steven J Ferris, Steven L Nail

AAPS PharmSciTech· May 2018

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The Influence of Mannitol Hemihydrate on the Secondary Drying Dynamics of a Protein Formulation: A Case Study.
Jayasree M Srinivasan, Lindsay A Wegiel, Lisa M Hardwick, Steven L Nail

J Pharm Sci· December 2017

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Recommended Best Practices for Process Monitoring Instrumentation in Pharmaceutical Freeze Drying-2017.
Steven Nail, Serguei Tchessalov, Evgenyi Shalaev, Arnab Ganguly, Ernesto Renzi

AAPS PharmSciTech· October 2017

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Lyophilized Drug Product Cake Appearance: What Is Acceptable?
Sajal Manubhai Patel, Steven L Nail, Michael J Pikal, Raimund Geidobler, Gerhard Winter

J Pharm Sci· July 2017

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Process and Formulation Effects on Protein Structure in Lyophilized Solids Using Mass Spectrometric Methods.
Lavanya K Iyer, Gregory A Sacha, Balakrishnan S Moorthy, Steven L Nail, Elizabeth M Topp

J Pharm Sci· May 2016

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A proposed rationale and test methodology for establishment of acceptance criteria for vacuum integrity testing of pharmaceutical freeze dryers.
Lisa M Hardwick, Steven L Nail, James Jarman, Kai Hasler, Thomas Hense

Eur J Pharm Biopharm· October 2013

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Experimental determination of the key heat transfer mechanisms in pharmaceutical freeze-drying.
Arnab Ganguly, Steven L Nail, Alina Alexeenko

J Pharm Sci· May 2013

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Quality by design in formulation and process development for a freeze-dried, small molecule parenteral product: a case study.
Linas N Mockus, Timothy W Paul, Nathan A Pease, Nancy J Harper, Prabir K Basu, Steven L Nail

Pharm Dev Technol· March 2012

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Controlled nucleation in freeze-drying: effects on pore size in the dried product layer, mass transfer resistance, and primary drying rate.
Alex K Konstantinidis, Wei Kuu, Lori Otten, Steven L Nail, Robert R Sever

J Pharm Sci· August 2011

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Thermal analysis of frozen solutions: multiple glass transitions in amorphous systems.
Gregory A Sacha, Steven L Nail

J Pharm Sci· September 2009

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Ice nucleation temperature influences recovery of activity of a model protein after freeze drying.
Teresa Cochran, Steven L Nail

J Pharm Sci· September 2009

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Professor Michael J. Pikal: scientist, family man, educator, colleague and friend.
Steven Nail

J Pharm Sci· September 2009

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Rapid freeze-drying cycle optimization using computer programs developed based on heat and mass transfer models and facilitated by tunable diode laser absorption spectroscopy (TDLAS).
Wei Y Kuu, Steven L Nail

J Pharm Sci· September 2009

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Evidence of partial unfolding of proteins at the ice/freeze-concentrate interface by infrared microscopy.
J Jeff Schwegman, John F Carpenter, Steven L Nail

J Pharm Sci· September 2009

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Computational analysis of fluid dynamics in pharmaceutical freeze-drying.
Alina A Alexeenko, Arnab Ganguly, Steven L Nail

J Pharm Sci· September 2009

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