title: A note on kinetic modeling of stability data and implications on pooling.
abstract: In this note we discuss the relationship between the underlying kinetic model and the statistical (or analytic) model used to study degradation. For small degradation rates, the zeroth, first, and second order statistical models give approximately the same fits and predictions on either the original assay scale or the percent of label claim scale. However, It is shown that the zeroth and second order statistical models artificially induce differential degradation rates across strengths when the percent of label claim response data are analyzed and poolability is not allowed across strengths. The first order model is free of this problem when the true degradation kinetics are first order. We make some recommendations in pooling stability data across strengths.
authors.affiliation: Johnson & Johnson Pharmaceutical Research & Development, LLC, Raritan, New Jersey 08869, USA.
authors.forename: Stan
authors.initials: S
authors.lastname: Altan
authors.forename: Damaraju
authors.initials: D
authors.lastname: Raghavarao
mesh_terms: D004355:Drug Stability; D004356:Drug Storage / Q000706:statistics & numerical data*; D007700:Kinetics; D015233:Models, Statistical; D013997:Time Factors