Pooling batches in drug stability study by using constant-width simultaneous confidence bands
Pooling batches in drug stability study by using constant-width simultaneous confidence bands
One important study objective in drug stability studies is to estimate the shelf-life of a drug. A key statistical problem involved in this is how to assess the practical equivalence of different batches of the same drug so that different batches can be subgrouped to produce a single shelf-life for the drug. In this paper constant-width simultaneous confidence bands are proposed to quantify the magnitude of difference between different batches, with a particular view to establish the practical equivalence of different batches. This approach is suitable for the situation that the intercepts and slopes of the regression lines for the batches cannot be assumed to be equal. It is shown how constant-width simultaneous confidence bands can be easily constructed for the multiple comparison of several general linear regression models. In particular, it is shown that constant-width simultaneous confidence bands have a better chance to establish the equivalence than, and so are preferable to, the hyperbola-shaped simultaneous confidence bands considered.
drug stability studies, equivalence, linear regression, multiple comparisons, multivariate t, simultaneous inference, statistical simulation
2759-2771
Liu, W.
b64150aa-d935-4209-804d-24c1b97e024a
Jamshidian, M.
88395558-70c0-4fc3-ba64-8262acc78068
Zhang, Y.
f812509d-2a3c-41aa-8ba1-68210952d5a6
Bretz, F.
51270819-e491-4a72-a410-679d86231e64
Han, X.L.
15a720d8-bf60-4bac-925d-73136bb787b6
June 2007
Liu, W.
b64150aa-d935-4209-804d-24c1b97e024a
Jamshidian, M.
88395558-70c0-4fc3-ba64-8262acc78068
Zhang, Y.
f812509d-2a3c-41aa-8ba1-68210952d5a6
Bretz, F.
51270819-e491-4a72-a410-679d86231e64
Han, X.L.
15a720d8-bf60-4bac-925d-73136bb787b6
Liu, W., Jamshidian, M., Zhang, Y., Bretz, F. and Han, X.L.
(2007)
Pooling batches in drug stability study by using constant-width simultaneous confidence bands.
Statistics in Medicine, 26 (14), .
(doi:10.1002/sim.2756).
Abstract
One important study objective in drug stability studies is to estimate the shelf-life of a drug. A key statistical problem involved in this is how to assess the practical equivalence of different batches of the same drug so that different batches can be subgrouped to produce a single shelf-life for the drug. In this paper constant-width simultaneous confidence bands are proposed to quantify the magnitude of difference between different batches, with a particular view to establish the practical equivalence of different batches. This approach is suitable for the situation that the intercepts and slopes of the regression lines for the batches cannot be assumed to be equal. It is shown how constant-width simultaneous confidence bands can be easily constructed for the multiple comparison of several general linear regression models. In particular, it is shown that constant-width simultaneous confidence bands have a better chance to establish the equivalence than, and so are preferable to, the hyperbola-shaped simultaneous confidence bands considered.
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Submitted date: 18 May 2006
Accepted/In Press date: 18 May 2006
Published date: June 2007
Keywords:
drug stability studies, equivalence, linear regression, multiple comparisons, multivariate t, simultaneous inference, statistical simulation
Organisations:
Southampton Statistical Research Inst.
Identifiers
Local EPrints ID: 42447
URI: http://eprints.soton.ac.uk/id/eprint/42447
ISSN: 0277-6715
PURE UUID: 612e5518-6600-4603-9328-d1c505404ab4
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Date deposited: 27 Sep 2007
Last modified: 16 Mar 2024 02:42
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Contributors
Author:
M. Jamshidian
Author:
Y. Zhang
Author:
F. Bretz
Author:
X.L. Han
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