Predicting shelf life stability of lyophilized drug products

Predicting shelf life stability of lyophilized drug products

A method of computational modeling to predict stability of a lyophilized drug product includes receiving model parameters describing a virtual cake, a virtual vial, a virtual stopper, and a virtual ambient environment. The method also includes computing, by implementing a computational model and at...

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Hauptverfasser: SCHLEGEL, Fabrice, CAPORINI, Marc A, KELLY, Ron Christopher, CHAVES, Mary
Format: Patent
Sprache:eng
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INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTEDFOR SPECIFIC APPLICATION FIELDS
PHYSICS
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creator SCHLEGEL, Fabrice
CAPORINI, Marc A
KELLY, Ron Christopher
CHAVES, Mary
description A method of computational modeling to predict stability of a lyophilized drug product includes receiving model parameters describing a virtual cake, a virtual vial, a virtual stopper, and a virtual ambient environment. The method also includes computing, by implementing a computational model and at each of a plurality of virtual time steps, a change in water amount or concentration in the virtual cake, virtual air within the virtual vial, and the virtual stopper, in part by applying the model parameters to the computational model. The method also includes generating information for display to a user via a user interface.
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subjects INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTEDFOR SPECIFIC APPLICATION FIELDS
PHYSICS
title Predicting shelf life stability of lyophilized drug products
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