Pharmacokinetics of Orally Inhaled Drug Products
نویسندگان
چکیده
منابع مشابه
Role of pharmacokinetics in establishing bioequivalence for orally inhaled drug products: workshop summary report.
In April 2010 a workshop on the "Role of Pharmacokinetics in Establishing Bioequivalence for Orally Inhaled Drug Products" was sponsored by the Product Quality Research Institute (PQRI) in coordination with Respiratory Drug Delivery (RDD) 2010. The objective of the workshop was to evaluate the current state of knowledge and identify gaps in information relating to the potential use of pharmacok...
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The inhalational drug market, especially the generic market, has a tremendous growth potential globally (GBI Research, 2011; Espicom, 2013; Transperancy: Market Research, 2013). Generics are drugs that are bioequivalent to the approved drugs. The United States Food and Drug Administration (FDA) has defined bioequivalence as (U.S. FDA, 2014), “The absence of a significant difference in the rate ...
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Although the information set out here focuses (because of their market leading positions) on the Andersen Cascade Impactor (ACI) and Next Generation Impactor (NGI), all multistage cascade impactors operate on the same principle: size fractionation on the basis of inertial impaction. Instruments such as the ACI and NGI consist of a series of stages each made up of a nozzle plate, with a specific...
متن کاملPharmacokinetics of inhaled drugs.
1. A high therapeutic ratio for the inhaled route of administration is achieved by delivering doses which achieve a high local concentration in the lung and relatively low levels of systemic absorption. 2. Pharmacokinetic evaluation of drug absorption from the lungs provides an accurate and reproducible method for comparing different inhaler delivery systems, as well as for evaluating bioequiva...
متن کاملEquivalence considerations for orally inhaled products for local action-ISAM/IPAC-RS European Workshop report.
The purpose of this article is to document the discussions at the 2010 European Workshop on Equivalence Determinations for Orally Inhaled Drugs for Local Action, cohosted by the International Society for Aerosols in Medicine (ISAM) and the International Pharmaceutical Consortium on Regulation and Science (IPAC-RS). The article summarizes current regulatory approaches in Europe, the United State...
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ژورنال
عنوان ژورنال: The AAPS Journal
سال: 2015
ISSN: 1550-7416
DOI: 10.1208/s12248-015-9736-6