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Shelf-life and its estimation in drug stability studies

Shelf-life and its estimation in drug stability studies
Shelf-life and its estimation in drug stability studies
One important property of any drug product is its stability over time. Drug stability studies are routinely carried out in the pharmaceutical industry in order to measure the degradation of an active pharmaceutical ingredient of a drug product. One important study objective is to estimate the shelf-life of the drug; the estimated shelf-life is required by the US Food and Drug Administration to be printed on the package label of the drug. This involves a suitable definition of the true shelf-life and the construction of an appropriate estimate of the true shelf-life. In this paper, the true shelf-life T? is defined as the time point at which 100?% of all the individual dosage units (e.g. tablets) of the drug have the active ingredient content no less than the lowest acceptable limit L, where ? and L are prespecified constants. The value of T? depends on the parameters of the assumed degradation model of the active ingredient content and so is unknown. A lower confidence bound Tˆ? for T? is then provided and used as the estimated shelf-life of the drug.
0266-4763
1989-2000
Liu, W.
b64150aa-d935-4209-804d-24c1b97e024a
Hsu, J.C.
b5fdbac8-26f4-4ac2-a009-c49a7bef5c51
Bretz, F.
51270819-e491-4a72-a410-679d86231e64
Hayter, A.J.
55bd07a5-db1d-4d3d-8c87-b307485420d9
Han, Y.
8cd0ca3e-648a-4c0f-904c-4f353ba9ebdb
Liu, W.
b64150aa-d935-4209-804d-24c1b97e024a
Hsu, J.C.
b5fdbac8-26f4-4ac2-a009-c49a7bef5c51
Bretz, F.
51270819-e491-4a72-a410-679d86231e64
Hayter, A.J.
55bd07a5-db1d-4d3d-8c87-b307485420d9
Han, Y.
8cd0ca3e-648a-4c0f-904c-4f353ba9ebdb

Liu, W., Hsu, J.C., Bretz, F., Hayter, A.J. and Han, Y. (2014) Shelf-life and its estimation in drug stability studies. Journal of Applied Statistics, 41 (9), 1989-2000. (doi:10.1080/02664763.2014.898135).

Record type: Article

Abstract

One important property of any drug product is its stability over time. Drug stability studies are routinely carried out in the pharmaceutical industry in order to measure the degradation of an active pharmaceutical ingredient of a drug product. One important study objective is to estimate the shelf-life of the drug; the estimated shelf-life is required by the US Food and Drug Administration to be printed on the package label of the drug. This involves a suitable definition of the true shelf-life and the construction of an appropriate estimate of the true shelf-life. In this paper, the true shelf-life T? is defined as the time point at which 100?% of all the individual dosage units (e.g. tablets) of the drug have the active ingredient content no less than the lowest acceptable limit L, where ? and L are prespecified constants. The value of T? depends on the parameters of the assumed degradation model of the active ingredient content and so is unknown. A lower confidence bound Tˆ? for T? is then provided and used as the estimated shelf-life of the drug.

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More information

Published date: 24 March 2014
Organisations: Statistics

Identifiers

Local EPrints ID: 369888
URI: http://eprints.soton.ac.uk/id/eprint/369888
ISSN: 0266-4763
PURE UUID: 8d1fbb87-c83f-438b-beaa-a90cc3b5746f
ORCID for W. Liu: ORCID iD orcid.org/0000-0002-4719-0345

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Date deposited: 08 Oct 2014 10:48
Last modified: 15 Mar 2024 02:43

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Contributors

Author: W. Liu ORCID iD
Author: J.C. Hsu
Author: F. Bretz
Author: A.J. Hayter
Author: Y. Han

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