10.1002/jps.2600781115.abs A method is presented according to which tolerances for active ingredient release from pharmaceutical dosage forms are calculated. The procedure is based on a statistical model. In accordance with this, the mean value is specified as a measure of the amount of active ingredient released, and the standard deviation as a measure of the uniformity of the active ingredient release. The determination of drug release tolerances is standardized. Based on clinically tested samples, changes arising from the manufacture and the storage are taken into account, thus establishing a manufacturing standard. Depending on the information available, a dynamic adaption of drug release tolerances (e.g., during the development phase) is recommended.
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