Equivalence Considerations for Orally Inhaled Products for Local Action—ISAM/IPAC-RS European Workshop Report
- 1 June 2012
- journal article
- research article
- Published by Mary Ann Liebert Inc in Journal of Aerosol Medicine and Pulmonary Drug Delivery
- Vol. 25 (3), 117-139
- https://doi.org/10.1089/jamp.2011.0968
Abstract
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 States, and Canada, and presents points of consensus as well as ongoing debate in the four major areas: in vitro testing, pharmacokinetic and pharmacodynamic studies, and device similarity. Specific issues in need of further research and discussion are also identified.Keywords
This publication has 44 references indexed in Scilit:
- Non-impactor-Based Methods for Sizing of Aerosols Emitted from Orally Inhaled and Nasal Drug Products (OINDPs)AAPS PharmSciTech, 2011
- Pharmacokinetic and pharmacodynamic comparison of hydrofluoroalkane and chlorofluorocarbon formulations of budesonideBritish Journal of Clinical Pharmacology, 2011
- Product Lifecycle Approach to Cascade Impaction MeasurementsAAPS PharmSciTech, 2011
- Relative Precision of Inhaler Aerodynamic Particle Size Distribution (APSD) Metrics by Full Resolution and Abbreviated Andersen Cascade Impactors (ACIs): Part 2—Investigation of Bias in Extra-Fine Mass Fraction with AIM-HRT ImpactorAAPS PharmSciTech, 2010
- Relative Precision of Inhaler Aerodynamic Particle Size Distribution (APSD) Metrics by Full Resolution and Abbreviated Andersen Cascade Impactors (ACIs): Part 1AAPS PharmSciTech, 2010
- In Vitro Considerations to Support Bioequivalence of Locally Acting Drugs in Dry Powder Inhalers for Lung DiseasesThe AAPS Journal, 2009
- Lung bioavailability of hydrofluoroalkane fluticasone in young children when delivered by an antistatic chamber/maskThe Journal of Pediatrics, 2006
- Plasma concentrations of inhaled corticosteroids in relation to airflow obstruction in asthmaBritish Journal of Clinical Pharmacology, 2006
- Pharmacokinetic and Pharmacodynamic Properties of Inhaled Beclometasone Dipropionate Delivered Via Hydrofluoroalkane-Containing DevicesClinical Pharmacokinetics, 2005
- Clinical comparability of albuterol delivered by the breath-actuated inhaler (Spiros) and albuterol by MDI in patients with asthmaAnnals of Allergy, Asthma & Immunology, 1999