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EVALUATION OF TESTS BASED ON INDIVIDUAL VERSUS POPULATION MODELING TO COMPARE DISSOLUTION CURVES.
- Source :
- Journal of Biopharmaceutical Statistics; Jul2001, Vol. 11 Issue 3, p107-123, 17p, 1 Chart
- Publication Year :
- 2001
-
Abstract
- This study is aimed at comparing dissolution curves obtained for several batches of sustained release formulations of octreotide, a somatostatin analog used in acromegaly. We evaluated four tests to compare the parameters of two series of curves: a Mann-Whitney-Wilcoxon test comparing individual estimates; a likelihood ratio test after population analysis (NONMEM), and two Wald tests using population parameters estimated by two-stage methods. The four approaches were evaluated by simulations. The Mann-WhitneyWilcoxon test and the population approach had adequate type-I error, and the latter provided the highest power under the alternatives simulated. The twostage method including the uncertainty on individual estimates was disappointing. [ABSTRACT FROM AUTHOR]
- Subjects :
- OCTREOTIDE acetate
REGRESSION analysis
BIOPHARMACEUTICS
Subjects
Details
- Language :
- English
- ISSN :
- 10543406
- Volume :
- 11
- Issue :
- 3
- Database :
- Complementary Index
- Journal :
- Journal of Biopharmaceutical Statistics
- Publication Type :
- Academic Journal
- Accession number :
- 8535156
- Full Text :
- https://doi.org/10.1081/BIP-100107652