Journal ArticleDOI
Statistical Analysis of Pharmaceutical Stability Data
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TLDR
In this paper, a method for establishing the shelf-life for a pharmaceutical product using data from long-term stability studies is presented, which utilizes the work of Fuller and Battese (1973).Abstract:
A method is presented for establishing the shelf-life for a pharmaceutical product using data from long-term stability studies The method utilizes the work of Fuller and Battese (1973) An example is given which illustrates the use of the method with a set of pharmaceutical stability dataread more
Citations
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Journal ArticleDOI
Statistical Evaluation of Stability Data of Pharmaceutical Products for Specification Setting
TL;DR: A strategy is proposed to set scientifically based, statistically justified specifications for a new drug product closely around stability data that have been generated in the course of registration stability testing.
Journal ArticleDOI
Shelf lives of aseptically prepared medicines – stability of hydrocortisone sodium succinate in PVC and non-PVC bags and in polypropylene syringes
TL;DR: The purpose of this study was to obtain ultimate shelf lives for typical formulations of hydrocortisone sodium succinate so that they may be prepared in bulk in appropriately licensed facilities.
Journal ArticleDOI
Accelerated temperature pharmaceutical product stabiliw determinations
TL;DR: A review of several calculation methods used to obtain a statistically valid estimate of an expiration date from isothermal accelerated temperature studies is given in this article, where a novel computer generated plot to compare zero, first and second order decay is presented as is a somewhat simplified set of nonlinear equations.
Journal ArticleDOI
The Application of Multiresponse Estimation to Drug Stability Studies
TL;DR: In this paper, a mathematical model based on kinetic theory is developed to describe both the disappearance of parent compound and appearance of degradation products, and the analysis of data obtained from accelerated testing of drug stability is accomplished by extending the kinetic model to include the Arrhenius relationship.
References
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Book
Statistical Manual of the Association of Official Analytical Chemists
E. H. Steiner,W. J. Youden +1 more
Journal ArticleDOI
Transformations for Estimation of Linear Models with Nested-Error Structure
TL;DR: In this article, two linear models with error structure of the nested type are considered and transformations are presented by which uncorrelated errors with constant variances are obtained, where the transformed observations are differences between the original observations and multiples of averages of subsets of the observations.
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