IPAC-RS Strategic Vision

David Cipolla, Terrence Tougas, Mary Devlin Capizzi, Don Chambers, Dave Parkins, Andy Rignall, Jackie Schumacher, Mary Ann Smith

A “Compare and Contrast” of International Guidelines Impacting the Pharmaceutical and Clinical Development of New and Subsequent Market Entry OINDPs.  Part A:  Clinical and Part B: CMC

J. Schumacher, R. Ormiston, R. Alekel, B. Berner, N. Bowles, M. James, J.R. Keegstra, S. Lyapustina, A. Rignall, C. Rogerson, B. Thompson

Establishing the Shelf Life of Pharmaceutical Products

Terrence Tougas, Suntara Cahya, David Christopher, Dennis Sandell

The IPAC-RS Supplier GMP Guideline: A Platform for New Directions in Supplier Quality Control

Barbara Falco, Paul Beasley, Thomas Gaspar, John Goulding, Thomas Haselwander, Louis Leger, Christian, Meusinger, Lee Nagao, Tanya Naidu, Linda Nield, Ray Oksala, Philippe Pitard, Suzette Roan, Andrew Saunders, Jo Ward, Andrew Wood

Points to Consider for a Pharmaceutical Development "P2" Report for OINDP:  An Industry View

Jackie Schumacher, Alex Bell, Mark Broughton, Mukul Dalvi, John Hart, Susan Holmes, Terry Kosobud, Paul Lucas, Lee Nagao, Tilo Schönbrodt, Mary Ann Smith, Terrence Tougas, Tony Wilkinson, Xian-Ming Zeng

Rationalized Approach to Chemistry, Manufacturing & Control (CMC) Requirements for Orally Inhaled and Nasal Drug Products (OINDPs) Based on Risk Management

Risk Managment Interactive Poster

Stephen Horhota, Robert Berger, Noel Butterworth, Barbara Davidson, Andrew Grant, Eric Johansson, Sebastian Kaerger, Stefan Leiner, Svetlana Lyapustina, Rajni Patel, Ann Purrington

USP Aerosols Experts Committee: Responsibilities and Activities

Anthony Hickey and Kahkashan Zaidi

Comparative Analysis of Manual Versus Automated Actuation Parameters for Droplet Size Determination by Laser Diffraction for Spray Devices

Robin  Spivey and LaMonica Ware

A Comparison of Different Approaches to Estimating the Mass Median Aerodynamic Diameter (MMAD) of OINDP Aerosols from Cascade Impactor Data

Terrence Tougas, David Christopher, Monisha Dey, Jolyon Mitchell, Svetlana Lyapustina, Michael Van Oort, Stephen Stein

Controlling Variability during Aerodynamic Particle Size Measurement

Sarah Walker, Debbie Kraus, Tamsin Jenkins, Liz Clift

Lean Data Analysis for Cascade Impaction Measurements

Terrence Tougas, Dave Christopher, Svetlana Lyapustina, Jolyon Mitchell, Helen Strickland, Bruce Wyka

Utilization of a climate box for optimization of cascade impaction measurements ensuring control of impactor temperature

Ellen Bitterle, Anke Luithlen, Karin Reul, Albert Bucholski, Manfred Keller

Analytical Methods Quality by Design (AM-QbD) Risk Assessments undertaken within GlaxoSmithKline (World Wide Inhaled Product Development) for Orally Inhaled and Nasal Drug Products

Andrew J. Crumpton, Geoffrey E. Daniels, Karl M. Ennis, and Nick C. Turner

The Discrimination of Robustness and Ruggedness Factors During the Evaluation of Analytical Methods for Orally Inhaled and Nasal Drug Products.

Andy Rignall, David Christopher, Andrew Crumpton, Kevin Hawkins, Sebastian Kaerger, Svetlana Lyapustina, Holger Memmesheimer, Adrian Parkinson, Mary Ann Smith

Quality by Design for Analytical  Methods Intended for Use with Orally Inhaled and Nasal Drug Products

Andy Rignall, David Christopher, Andrew Crumpton, Karl Ennis, Kevin Hawkins, Sebastian Kaerger, Svetlana Lyapustina, Holger Memmesheimer, Adrian Parkinson, Mary Ann Smith

Quality by Design Systematic Chromatographic Method Development

Oscar Liu, Justin Pennington, Tina Masiuk, Zhenyu Wang, Honggen Zhang, Kevin DeBoyace, Pallavi Mehta, Brent Donovan

The Extractables and Leachables Safety Information Exchange (ELSIE): Developing an Extractables/Leachables Database

Douglas Ball, Steve Beck, Arthur Shaw

How Low can we Go?  Sensitivity and the Analytical Evaluation Threshold for Leachables

James Mullis, Scott Pennino, Daniel Norwood

Investigating Paradigms for Extractables and Leachables Management in Orally Inhaled and Nasal Drug Products

Daniel L. Norwood, Cheryl L.M. Stults, Tim Chesworth, David Christopher, Antonio Medina, Lee Nagao, Ann Purrington, Arthur Shaw, Caesar Snodgrass-Pilla, Terrence Tougas, Benoit Walter

Tackling the Extractables and Leachables Challenge:  Managing Extractables Along the Supply Chain

Cheryl Stults, Barbara Falco, Matthew Coates, Jason Creasey, Daniel Dohmeier, Andrew Feilden, Simon Kaar, James Mullis, Lee Nagao, Daniel Norwood, Gaby Reckzuegel, Bobbijo Redler, Andy Rignall, Caesar Snodgrass-Pilla, Xian-Ming Zeng

Use of Designed Experiments to  Understand and Control Variability of Extractables

Nathan Knotts, William Duffield, Arthur J. Shaw, Suzette Roan, Cheryl L.M. Stults

Development of Robust Capsule based Dry Powder Inhalation Formulations:  Moving towards Quality by Design

Angela Armanni, Ruth Leu Marseiler, Mukul Dalvi, Markus Otz, Jean-Daniel Bonny

From Understanding to Control:  A Successful Application of Multivariate Modeling in Commercial Manufacturing

Beth Morgan, Chris Wong, Wilvan Wee, Brad Flynn, Mike Bowley

Predicting bronchodilator response of a short acting beta-2-agonist from aerodynamic particle size data using artificial neural networks

M. de Matas, Q. Shao, M. Biddiscombe, H. Chrystyn, P.J. Barnes, O.S. Usmani

Detecting Siliceous Flakes in Glass Containers using Microscopic Techniques

Frank Bales, Brian Mitchell

Foreign Particles Method Development and Identification in Inhalable Drug Products with Single Particle Explorer in the QbD Paradigm

Oliver K. Valet, Markus Lankers

Simultaneous Raman micro-spectroscopy and Morphological analysis of Particles from an Orally Inhaled Product – A Novel Analytical Approach for QbD

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