Theme: Current Scientific and Regulatory Approaches for Development of Orally Inhaled and Nasal Drug Products

ISSN: 1550-7416 (Online)

In this topical collection (11 articles)

  1. No Access

    Research Article

    Application of the Modified Chi-Square Ratio Statistic in a Stepwise Procedure for Cascade Impactor Equivalence Testing

    Benjamin Weber, Sau L. Lee, Renishkumar Delvadia, Robert Lionberger… Pages 370-379

  2. No Access

    Meeting Report

    Inhalation Devices and Patient Interface: Human Factors

    Stefan Leiner, David Parkins, Orest Lastow Pages 457-461

  3. No Access

    Meeting Report

    Safety of β2-Agonists in Asthma: Linking Mechanisms, Meta-Analyses and Regulatory Practice

    Sanjeeva. B. Dissanayake Pages 754-757

  4. No Access

    Meeting Report

    Pharmacodynamic Studies to Demonstrate Bioequivalence of Oral Inhalation Products

    Leslie Hendeles, Peter T. Daley-Yates, Robert Hermann, Jan De Backer… Pages 758-768

  5. No Access

    Meeting Report

    Pharmacokinetics of Orally Inhaled Drug Products

    Günther Hochhaus, Stephen Horhota, Leslie Hendeles, Sandra Suarez… Pages 769-775

  6. Review Article

    In Vitro Testing for Orally Inhaled Products: Developments in Science-Based Regulatory Approaches

    Ben Forbes, Per Bäckman, David Christopher, Myrna Dolovich, Bing V. Li… Pages 837-852
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  7. No Access

    Research Article

    In Vitro, Pharmacokinetic, Pharmacodynamic, and Safety Comparisons of Single and Combined Administration of Tiotropium and Salmeterol in COPD Patients Using Different Dry Powder Inhalers

    Stephen T. Horhota, Jan A. van Noord, Cynthia B. Verkleij, Loek J. Bour… Pages 871-880

  8. No Access

    Commentary

    The Two Main Goals of Bioequivalence Studies

    Laszlo Endrenyi, Henning H. Blume, Laszlo Tothfalusi Pages 885-890

  9. Research Article

    Effect of Device Design and Formulation on the In Vitro Comparability for Multi-Unit Dose Dry Powder Inhalers

    Jagdeep Shur, Bhawana Saluja, Sau Lee, James Tibbatts, Robert Price Pages 1105-1116
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  10. Meeting Report

    Regulatory Considerations for Approval of Generic Inhalation Drug Products in the US, EU, Brazil, China, and India

    Sau L. Lee, Bhawana Saluja, Alfredo García-Arieta… Pages 1285-1304
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  11. Meeting Report

    Current Scientific and Regulatory Approaches for Development of Orally Inhaled and Nasal Drug Products: Overview of the IPAC-RS/University of Florida Orlando Inhalation Conference

    Guenther Hochhaus, Craig Davis-Cutting, Martin Oliver, Sau L. Lee… Pages 1305-1311
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