Details
| Original language | English |
|---|---|
| Pages (from-to) | 985-995 |
| Number of pages | 11 |
| Journal | Journal of Biopharmaceutical Statistics |
| Volume | 18 |
| Issue number | 5 |
| Publication status | Published - 10 Sept 2008 |
Abstract
Stability testing is a procedure frequently used in the pharmaceutical industry to estimate the shelf life of a drug. Hereby, a standard problem of interest is whether or not to pool a given number of batches to assign a single shelf life for the combined batches. In this paper, we propose two modified methods for the pooling process. One is based on the relative average drug contents of batches at a target shelf life, which basically involves specification of thresholds in relative terms, and the other is tests for the equivalence of shelf lives (using ratios of shelf lives) at a specified lower acceptance criteria of label claim. For both approaches, marginal and simultaneous confidence intervals are established. The methods will be illustrated using two different stability data. A simulation study is conducted to investigate the coverage probability of the proposed methods.
Keywords
- Average drug content, Label claim, Multiple comparison, Shelf life
ASJC Scopus subject areas
- Mathematics(all)
- Statistics and Probability
- Pharmacology, Toxicology and Pharmaceutics(all)
- Pharmacology
- Medicine(all)
- Pharmacology (medical)
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In: Journal of Biopharmaceutical Statistics, Vol. 18, No. 5, 10.09.2008, p. 985-995.
Research output: Contribution to journal › Article › Research › peer review
}
TY - JOUR
T1 - Equivalence tests for shelf life and average drug content in stability studies
AU - Djira, Gemechis D.
AU - Hothorn, Ludwig A.
AU - Tsong, Yi
PY - 2008/9/10
Y1 - 2008/9/10
N2 - Stability testing is a procedure frequently used in the pharmaceutical industry to estimate the shelf life of a drug. Hereby, a standard problem of interest is whether or not to pool a given number of batches to assign a single shelf life for the combined batches. In this paper, we propose two modified methods for the pooling process. One is based on the relative average drug contents of batches at a target shelf life, which basically involves specification of thresholds in relative terms, and the other is tests for the equivalence of shelf lives (using ratios of shelf lives) at a specified lower acceptance criteria of label claim. For both approaches, marginal and simultaneous confidence intervals are established. The methods will be illustrated using two different stability data. A simulation study is conducted to investigate the coverage probability of the proposed methods.
AB - Stability testing is a procedure frequently used in the pharmaceutical industry to estimate the shelf life of a drug. Hereby, a standard problem of interest is whether or not to pool a given number of batches to assign a single shelf life for the combined batches. In this paper, we propose two modified methods for the pooling process. One is based on the relative average drug contents of batches at a target shelf life, which basically involves specification of thresholds in relative terms, and the other is tests for the equivalence of shelf lives (using ratios of shelf lives) at a specified lower acceptance criteria of label claim. For both approaches, marginal and simultaneous confidence intervals are established. The methods will be illustrated using two different stability data. A simulation study is conducted to investigate the coverage probability of the proposed methods.
KW - Average drug content
KW - Label claim
KW - Multiple comparison
KW - Shelf life
UR - http://www.scopus.com/inward/record.url?scp=51649125724&partnerID=8YFLogxK
U2 - 10.1080/10543400802287230
DO - 10.1080/10543400802287230
M3 - Article
C2 - 18781530
AN - SCOPUS:51649125724
VL - 18
SP - 985
EP - 995
JO - Journal of Biopharmaceutical Statistics
JF - Journal of Biopharmaceutical Statistics
SN - 1054-3406
IS - 5
ER -