Albuterol in situ Bioadhesive Nasal Inserts of Albuterol Sulphate

Mohamed Etman, Raga Farid, Abdelazim Ebian, Aly Nada

Oral Inhalation Therapy for Broncho-Constrictive Disease Management: Meeting the Challenge of Developing More Patient Appropriate Devices

Jolyon Mitchell

In Vitro Evaluation of Poorly Soluble Inhalation Compounds: Effect of Media, Lactose, Drug Particle Size and Concentration

Susan Heimbecher, Nastaran Sigari and Nishit Patel

Summary of Techniques for Measuring Dissolution of Orally Inhaled Products: Review of Published Applications

Andrew Cooper, Trevor Riley, Dave Christopher, Jan Arp, Agnes Colombani, Svetlana Lyapustina, Janet Maas, Jolyon Mitchell, Maria Reiners, Frank Thielmann, Terrence Tougas

Application of the Abbreviated Impactor Measurement (AIM) concept: A Reduced Extraction Method for the Andersen Cascade Impactor

Shari Sellers, Jennifer Wylie, Brent Donovan

Influence of Stability Effects on Delivered Dose PTIT Acceptance Probabilities

Hans-Joachim Delzeit and Stefan Leiner

In Vivo Nasal Deposition from Different Delivery Devices and Formulations

Samir Shah, Chris George, Robert Berger, Pranav Gupta, Jason Wan, David Monteith, Alyson Connor, John McDermott, Wu Lin

Design of Experiments to Optimize an In Vitro Nasal Cast to Predict Human Nasal Drug Deposition

Samir Shah, Chris George, Walter Horodnik, Joel Sequeira, David Monteith, Colin Dickens, Anna Banaszek, David Ward

Influence Of Gamma-Radiation On Additives In HDPE – Used For Primary Packaging Components

Daniela Marx, Dr. Holger-Thorsten Steinführer

Application and Limitation of QbD principles in method development and validation

Heike Gottschalg, Rüdiger Gössl, Dr. Holger Memmesheimer

Novel Adaptation of a Laser Diffraction Measurement Technique

Chad Smutney, Benoit Adamo, Art Hamfeldt, Saiyam Shah

Pressure Profiling In Development of a Dry Powder Delivery System

Chad Smutney, Benoit Adamo, John Polidoro, Brendan Laurenzi, Carl Sahi

Considerations For Human Factors In Developing A Pulmonary Drug/Device Delivery System

P. Spencer Kinsey and Chad Smutney

Imaging deposited particles in airways of laboratory animals

Anthony Wexler, Praveen Srirama, Chris Wallis, and DongYoub Lee

How Do We Ensure Material Quality for OINDP?

James Mullis, Gaby Reckzuegel, Andrew Feilden, Jason M. Creasey, Mike Hodgson, Bobbijo Redler, Cheryl L. M. Stults, Daniel Dohmeier, Lisa Dick, Fred Adair, Lee Nagao, Maggie Liu

How PTI-TOST, Control Strategy Principles and Acceptance Sampling Consensus Standards can Work Together to Achieve an Appropriate Quality Assessment Strategy of Delivered Dose Uniformity of OIPs

Helen Strickland, Lee Clewley and DDU Working Group

Non-Impactor-Based Methods for Sizing of Aerosols Emitted from Oral and Nasal Inhaler Drug Products (OINDP)

Richard Bauer, Jolyon Mitchell, Svetlana Lyapustina, Terrence Tougas

A Risk Based Approach to Device Design, Development & Industrialisation

Mike D Hodgson, Declan Reilly, Charles Godfrey, Stuart Broughton & Ian Vaughan

Analytical methods Quality by Design (AM-QbD) approach implemented within GlaxoSmithKline (Inhaled Product and Device Technology) for Orally Inhaled Drug Products

Geoffrey E Daniels, Andrew J Crumpton

How Can Knowledge Space Concepts be Applied to Extractables and Leachables Management in OINDP?

Cheryl L. M. Stults , Tim Chesworth , Arthur Bailey, David Christopher , Diego Copelli, Federica Fochi, Gerard Linnane, Jaromir Mikle, Lee M. Nagao , Ann Purrington, Terrence Tougas, Benoit Walter , Oliver Whelehan, Olga Yee, Alex Zuyev

ELSIE: A Comprehensive Database Optimized for the Selection of Materials and Risk Assessment of Leachables and Extractables

Douglas Ball, Steve Beck, Arthur Shaw, Lee Nagao

Advantages of Atmospheric Pressure Gas Chromatography (APGC) Ionization in Extractable Identification

Baiba Cabovska, Douglas Stevens, John Cunningham, Sam Shum, and Arthur Bailey

Development of Dissolution Methodology for Dry Powder Inhalation Aerosols

Jason Mees, Craig Fulton, Suzanne Wilson, Nicola Bramwell, Marilyn Lucius & Andrew Cooper

Platform Formulation Development Using a Novel Pulmonary Excipient and In Vitro Evaluation of a Model Formulation of Fluticasone Propionate

David T. Vodak, Dan E. Dobry, Philip J. Kuehl, Melanie Doyle-Eisele, Jacob D. McDonald, Dwayne T. Friesen,Warren K. Miller, David K. Lyon

Drug Delivery to the Sinuses via Pulsating Aerosols - Results from a Scintigraphic Deposition Study in Healthy Volunteers

Winfried Möller, Uwe Schuschnig, Gülnaz Khadem Saba, Karl Häussinger, Manfred Keller, Lisa Cambridge

An Investigational Patient Monitoring System to Generate Objective Information on Patients Drug Adherence to Inhaled Medications

Carola Fuchs, Lisa Cambridge, Wolfgang Achtzehner, Robert P Notifiedorski, Stefan Seemann and Martin Knoch

Principle Component Analysis as a tool for description of Aerodynamic Particle Size Distribution

Alan Silcock, Rachel Brody

Determination of Particle Size Distribution of an Orally Inhaled Drug Product: Automated Microscopy and Raman Spectroscopy

Linda H. Kidder, Kenneth S. Haber, Janie Dubois, and E. Neil Lewis

The EPAG Workshop on the Abbreviated Impactor Concept (AIM) in December 8th 2010 in Edinburgh, UK: Status, Key Results and Future Needs in Oral Inhaled Product (OIP) Testing

Jolyon Mitchell and Steve Nichols

Dissolution Testing for Inhaled Products

Maria Reiners, Birte Jensen, Markus Wolkenhauer, Petra Ritzheim, Marc Egen

Regulatory Science and Guidance for Orally Inhaled and Nasal Drug Products

Jackie Schumacher, Ray Ormiston, Bettina Berner, Nicholas Childerhouse, Jeffrey Ding, Greg Howe, Michael James, J.R. Keegstra, Rosella Musa, Tiziana Peveri, Andy Rignall, Mary Ann Smith, Eileen Wyka, Svetlana Lyapustina, Ilse Peterson, Chihiro Ikegami

FDA Approval Times for OINDPs: A Review 2000-2010

Ray Ormiston

Review of Approaches to Managing Device Changes within OINDPs

Guillame Brouet, Stuart Broughton, Lennart Brunnberg, Tim Chesworth, Andrew Cooper, Andy Dundon, Stephen Eason, John Hart, Simon Karr, Paul Lafferty, Paul Lucas, Svetlana Lyapustina, Richard Moody, Ilse Peterson, Graham Purkins, Marc Rohrschneider, Roisin Wallace, Andrew Wood, Alex Zuyev