Comparison of dissolution profiles

Gohel MC, Panchal MK. Refinement of lower acceptance value of the similarity Factor F2 in comparison of dissolution profiles. Dissol Technol 2002 9(1). 

Moore JW, Flanner HH. Mathematical comparison of dissolution profiles. Pharm Tech 1996 20 64-74. 

The most common approach for the comparison of dissolution profiles is model-independent approach using the similarity factor f2. The pre-requisites for using the /2-test are the following ... 

In general, if an IVIVC method has been established, the requirement for additional dissolution test conditions is waived in favor of multi-point dissolution testing according to the in vitro method with which the IVIVC has been established. For level 3 changes, multi-point dissolution testing according to application-release test conditions is required in addition to in vivo BE. If IVIVC is available, this requirement is reduced to comparison of dissolution profiles of... 

Moore, J. W. and H. H. Flanner, Mathematical Comparison of Dissolution Profiles, Pharmaceutical Technology, 6 64-74, 1996. 

Costa, P. and Lobo, J., Modeling and comparison of dissolution profiles,... 

To ensure interchangeability, the multisource product must be therapeutically equivalent to the comparator product. Types of in vivo bioequivalence studies include pharmacokinetic studies, pharmacodynamic studies and comparative clinical trials. Direct practical demonstration of therapeutic equivalence in a clinical study usually requires large numbers of patients. Such studies in humans can be financially daunting, are often unnecessary and may be unethical. For these reasons the science of bioequivalence testing has been developed over the last 40 years. According to the tenets of this science, therapeutic equivalence can be assured when the multisource product is both pharmaceutically equivalent/alternative and bioequivalent. Assuming that in the same subject an essentially similar plasma concentration time course will result in essentially similar concentrations at the site(s) of action and thus an essentially similar therapeutic outcome, pharmacokinetic data may be used instead of therapeutic results. In selected cases, in vitro comparison of dissolution profile of the multisource product with that of the comparator product, or dissolution studies, may be sufficient to provide indication of equivalence. 

Other appropriate statistical methods can also be used for comparison of dissolution profiles, provided that the same criterion is used for acceptance (maximum 10% difference between the profiles). 

A special case occurs when two dissolution profiles are compared. This is often the case when a change has been introduced in the composition, manufacturing process or manufacturing site. The aim is then to maintain the same dissolution properties as for the original version. Such comparisons of dissolution profiles are performed by calculating a similarity factor, f2, which is calculated as follows from cumulative mean data (Shah et al. 1998) ... 

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