Related Experiment Video
Updated: Aug 1, 2026

Coherent anti-Stokes Raman Scattering (CARS) Microscopy Visualizes Pharmaceutical Tablets During Dissolution
Published on: July 4, 2014
Evaluation of tests based on individual versus population modeling to compare dissolution curves
1Inserm U 436, CHU Pitié-Salpêtrière, 91 Bd de l'Hôpital, Paris, France. eco@biomath.jussieu.fr
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.
Related Concept Videos
Analysis of Population Pharmacokinetic Data
In Vitro Drug Release Testing: Overview, Development and Validation
In Vitro Drug Dissolution: Compendial Testing Models I
In Vitro Drug Dissolution: Compendial Testing Models II
In Vitro Drug Dissolution: Alternative Methods
Drug Dissolution: Requirements and Profile Comparison

