The Use of Restriction Errors in the Design of Experiments

Abstract

AbstractBy Incorporating restriction errors into experimental design models, the developmental scientist is forced to consider what restrictions on randomization have been placed on his experiment whether they are inadvertent or planned. With the experimental design in mind along with the restriction errors the scientist should be able to eventually establish a very reasonable design model and analysis for that experiment.One of the more fundamental tools of pharmaceutical research and development, particularly in the design of dosage forms, is that of the accelerated stability test (1). In general, accelerated testing done early in the development scheme is designed to screen the formulation for the effects caused by changing variables. Variables are anything associated with the formula or the manufacturing of the formula. Many developmental scientists would change only one variable at a time. While this may be sound advice occasionally, it is time consuming and could actually miss the most important eff...