title: Evaluation of tests based on individual versus population modeling to compare dissolution curves.
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-Whitney-Wilcoxon test and the population approach had adequate type-I error, and the latter provided the highest power under the alternatives simulated. The two-stage method including the uncertainty on individual estimates was disappointing.
authors.affiliation: Inserm U 436, CHU Pitié-Salpêtrière, 91 Bd de l'Hôpital, Paris, France. eco@biomath.jussieu.fr
authors.forename: E
authors.initials: E
authors.lastname: Comets
authors.forename: F
authors.initials: F
authors.lastname: Mentré
mesh_terms: D000465:Algorithms; D003198:Computer Simulation; D004339:Drug Compounding; D006728:Hormones / Q000493:pharmacokinetics / Q000592:standards; D015233:Models, Statistical; D015282:Octreotide / Q000493:pharmacokinetics / Q000592:standards; D011153:Population; D012995:Solubility
chemical_list: D006728:Hormones; D015282:Octreotide