Accelerated storage tests on pharmaceutical products: effect of error structure of assay and errors in recorded temperature-Reference-Cited by-同舟云学术

Accelerated storage tests on pharmaceutical products: effect of error structure of assay and errors in recorded temperature

Published:1980-09 Issue:1 Volume:32 Page:155-159
ISSN:2042-7158
Container-title:Journal of Pharmacy and Pharmacology
language:en
Short-container-title:

Author:

Davies O L¹,Budgett D A²

Affiliation:

1. University College of Wales, Aberystwyth

2. ICI Ltd., Pharmaceuticals Division, Alderley Park, Macclesfield, Cheshire, UK

Abstract

Abstract The likely error structure for accelerated shelf-life studies is discussed. How to fit the Arrhenius relationship in the presence of this structure is shown and it is concluded that test potencies between 20% and 50% are likely to provide most information. The effect of temperature errors on the estimation of shelf-life is also considered.

Publisher

Oxford University Press (OUP)

Subject

Pharmaceutical Science,Pharmacology

Link

http://academic.oup.com/jpp/article-pdf/32/1/155/37762334/j.2042-7158.1980.tb12881.x.pdf

Reference4 articles.

1. Predicting the Stability of Biological Standards and Products

Cited by 15 articles. 订阅此论文施引文献订阅此论文施引文献，注册后可以免费订阅5篇论文的施引文献，订阅后可以查看论文全部施引文献

1. Using accelerated drug stability results to inform long-term studies in shelf life determination;Statistics in Medicine;2018-05-15

2. Data Evaluation and Statistical Methods;Accelerated Predictive Stability;2018

3. Drug Stability and Degradation Studies;Developing Solid Oral Dosage Forms;2017

4. Drug Stability and Degradation Studies;Developing Solid Oral Dosage Forms;2009

5. Protective Packaging;Physical Principles of Food Preservation;2003-06-20