Guidelines on Dissolution Profile Comparison
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Guidelines on Dissolution Profile Comparison Gudrun Freitag Drug Information Journal 2001 35: 865 DOI: 10.1177/009286150103500325 The online version of this article can be found at: http://dij.sagepub.com/content/35/3/865
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Drug Informotion Journal, Vol. 35, pp. 865-874, 2001 Printed in the USA. All rights reserved.
0092-8615/2001
Copyright 0 2001 Drug Information Association Inc.
GUIDELINES ON DISSOLUTION PROFILE COMPARISON GUDRUNFREITAG Ruhr-UniversitLt Bochum, Abteilung fur Medizinische Informatik, Biometrie und Epidemiologie. Bochum, Germany
This article presents a short review on guidelines for dissolution profile testing, particularly focusing on the recommendations regarding statistical methods for assessing profile similarity. In this context, the guidelines on in vitroh vivo correlations and on granting biowaivers are outlined briefly. The comparison of two dissolution profiles can be performed in different ways. There are many model-dependent and model-independent procedures suggested in the methodical literature. Current guidelines primarily recommend the application of a method based upon the f2 statistic as a measure of the similarity of two dissolution curves, though this procedure has often been criticized recently. The goal of this article is to give a survey of the current guidelines, including a description and discussion of the recommended methods for data analysis. Key Words: Dissolution profiles; Equivalence testing; In vitrolin vivo correlation; Bio-
waivers
INTRODUCTION THE DISSOLUTION characteristics under physiological conditions of a solid dosage form of a drug are influential on its in vivo absorption. Thus, the in vitro dissolution may be relevant for the prediction of the in vivo performance of a drug product. The importance of the dissolution properties depends particularly upon the release form of the drug product, for example, whether it is an immediate release or an extended release product, and on the solubility and permeability properties of the drug product. In vitro dissolution testing, that is, the determination of the rate and extent of drug release in an in vitro experiment, is well established as a monitoring technique for the performance of a drug product, and it is routinely used in the development and quality control of drugs and medicinal products. The
Reprint address: Gudrun Freitag, Ruhr-Universitat Bochum, Abteilung fur Medizinische Informatik, Biometrie und Epidemiologie. D-44780, Bo
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