منابع مشابه
Profile analysis for assessing in vitro bioequivalence.
For locally acting drug products such as nasal aerosols and nasal sprays, therapeutic equivalence between two drug products may be established by in vitro bioequivalence studies based on measurements intended to reflect the rate and extent to which the active ingredient becomes available at the site of action. For cascade impaction or multistage liquid impinger for particle size distribution, p...
متن کاملEstablishing bioequivalence in complete and incomplete data designs using AUCs.
Nonclinical in vivo animal studies have to be completed before starting clinical studies of the pharmacokinetic behavior of a drug in humans. The drug exposure in animal studies is often measured by the area under the concentration versus time curve (AUC). The classical complete data design where each animal is sampled for analysis at every time point is applicable for large animals only. In th...
متن کاملBioequivalence & Bioavailability
Modeling and simulation methods are now commonly used in drug product development and regulatory drug review process. These applications include, but are not limited to: the development of biorelevant specifications, determination of bioequivalence matrixes for modified release products with rapid therapeutic onset, design of in vitro-in vivo correlations in a mechanistic framework, and predict...
متن کاملBioequivalence & Bioavailability
Atorvastatin is a lipid-lowering agent, approved for treatment once daily at 10-80 mg doses in adults and at 10-20 mg doses in children aged 10 years or older [15]. Following oral administration, atorvastatin is rapidly absorbed, and maximum plasma concentrations are achieved within 1 to 2 hours. Atorvastatin is extensively metabolized by cytochrome P450 3A4 to active metabolites: orthoand para...
متن کاملBioequivalence & Bioavailability
The pharmacokinetics of olanzapine are linear and doseproportional within the approved dosage range from 1 mg up to 20 mg. Olanzapine is well absorbed following oral administration in both fed and fasted states . Food does not affect the rate or the extent of olanzapine absorption. Time of peak concentration ranges from 2-7 h [4,5]. Olanzapine is extensively distributed throughout the body, bin...
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ژورنال
عنوان ژورنال: Translational and Clinical Pharmacology
سال: 2020
ISSN: 2289-0882,2383-5427
DOI: 10.12793/tcp.2020.28.e20