RDD Online's Training Modules are on-demand, narrated Powerpoint presentations. They are 30 to 60 minutes long and can be viewed at one sitting or in segments repeated or reviewed over several days.
A multiple choice or drag-and-drop test is offered when listeners feel they have mastered the content. Those scoring more than 80% are sent an email certificate documenting their successful completion of the module. These modules can contribute toward professional development hours.
All modules are narrated by Stephen P. Newman Ph.D., a renowned expert in the field of aerosol drug delivery as well as the author of Respiratory Drug Delivery: Essential Theory and Practice, published by RDD Online and Virginia Commonwealth University.
All online training modules coordinate with the RDD: Essential Theory and Practice textbook.
By Dr. Stephen P. Newman
Free access made possible by the generous support of Respiratory Drug Delivery.
Learning Objectives
After completion of this module the participant should be able to demonstrate by successful completion of 15 questions their understanding of:
- Drugs administered by the inhaled route for both local and systemic delivery
- History of pulmonary drug delivery
- Basic anatomy and physiology of the respiratory tract
- Simple lung function testing
- Advantages and limitations of the pulmonary route
- Introduction to inhaler devices
By Dr. Stephen P. Newman
Free access made possible by the generous support of i2c Pharmaceutical Services.
Learning Objectives
After completion of this module the participant should be able to demonstrate by successful completion of 15 questions their understanding of:
- Fundamental properties of aerosols
- Mechanisms of aerosol deposition
- Factors that influence aerosol deposition
- Techniques which are used to assess pulmonary drug delivery including gamma scintigraphy
- Assessment of pulmonary bioavailability using pharmacokinetic techniques
- In Vitro In Vivo Correlations
By Dr. Stephen P. Newman
Free access made possible by the generous support of PARI Pharma.
Learning Objectives
After completion of this module the participant should be able to demonstrate by successful completion of 15 questions their understanding of:
- The principle of operation and characteristics of jet, ultrasonic and vibrating mesh nebulizers
- Factors that influence the performance of nebulizers
- Control of inhalation from nebulizers using Adaptive Aerosol Delivery and related systems
- Nebulizer formulations
- In Vitro characterization of nebulizers e.g. droplet size, drug output
- Role of nebulizers in practice
- Advantages and disadvantages of nebulizers
By Dr. Stephen P. Newman
Free access made possible by the generous support of Aptar Pharma.
Learning Objectives
After completion of this module the participant should be able to demonstrate by successful completion of 15 questions their understanding of:
- How pressurized metered dose inhalers (pMDIs) function, and the role of each formulation and hardware component
- What issues are important in chlorofluorocarbon propellant replacement, and the benefits of newer hydrofluoroalkane formulations
- Correct and incorrect pressurized inhaler use and optimal inhalation technique
- Advantages and disadvantages of pMDIs
By Dr. Stephen P. Newman
Free access made possible by the generous support of Philips Respironics.
Learning Objectives
After completion of this module the participant should be able to demonstrate by successful completion of 15 questions their understanding of:
- The potential benefits, limitations and mode of operation of breath-actuated and breath co-ordinated pressurized devices used in association with pressurized metered dose inhalers (pMDIs)
- The potential benefits, limitations and mode of operation of velocity modifying devices used in association with pressurized metered dose inhalers (pMDIs)
- The potential benefits, limitations and mode of operation of add-on devices including tube spacers, holding chambers, reverse flow devices used in assocation with pressurized metered dose inhalers (pMDIs)
- The range of inhalation techniques that are required to successfully utlize each class of add-on device
- The influence of electrostatic charge effects and washing processes on spacer performance
- Advantages and disadvantages of additional technologies used with pMDIs
By Dr. Stephen P. Newman
Free access made possible by the generous support of Vectura.
Learning Objectives
After completion of this module the participant should be able to demonstrate, by successful completion of 15 questions, their understanding of:
- The different categories of dry powder inhalers e.g. unit dose, multiple unit dose, multidose, passive and active devices
- Device and formulation factors that influence the performance of DPIs
- Pulmonary deposition from DPIs and the importance of device resistance and inhaled flow rate on their efficiency
- Correct use of DPIs and common handling errors
- Advantages and disadvantages of DPIs
By Dr. Stephen P. Newman
Free access made possible by the generous support of RDD Online.
Learning Objectives
After completion of this module the participant should be able to demonstrate by successful completion of 12 questions their understanding of:
- The role of novel portable inhaler technologies in aerosol therapy
- Principle of operation and characteristics of novel portable inhaler technologies including spraying via narrow nozzles, condensation generators, electrohydrodynamics, thermal ink jet technology
- Comparison of novel portable inhaler technologies with pressurized metered dose inhaler and dry powder inhalers
- Advantages and disadvantages of novel portable inhaler technologies
SELECTED RDD CONFERENCE PRESENTATIONS
A selection of presentations, originally presented at RDD Conferences are available as PDFs while some have been developed as interactive PowerPoint presentations synchronized with narration. Listeners can easily navigate the interactive presentations using player buttons or slide thumbnails, or via a Search function. Presentations may be viewed on either a PC or Mac and require the Adobe Flash Player.
Richard T. Lostritto, Ph.D., U.S. Food and Drug Administration, Silver Spring, Maryland, USA.
Dr Lostritto presented the highlights of the April 2018 Draft FDA Guidance at Respiratory Drug Delivery 2018 in Tucson, Arizona.
Robert Lionberger, Ph.D., U.S. Food and Drug Administration, Silver Spring, Maryland, USA
Dr Lionberger reviewed new tools to maximize prospects of FDA approval for generic OINDPs at Respiratory Drug Delivery 2018 in Tucson, Arizona.
Kimberley Witzmann, MD, U.S. Food and Drug Administration, Silver Spring, Maryland, USA
Dr Witzmann described the role of comparative analyses for evaluation of generic drug-device combinations at Respiratory Drug Delivery 2018 in Tucson, Arizona.
The podium presentations and discussion were recorded at RDD Europe 2013 in Berlin, Germany. This 2-hour session provides an overview of the transatlantic differences in clinical testing requirements for LABA/ICS combinations including perspectives from regulators and industry, ending with a panel discussion chaired by Leslie Hendeles.
A complimentary copy of the advocacy article as published in RDD Europe 2013 Proceedings.
This free presentation has been made possible by the generous support of RDD Online.
Transatlantic Differences in Clinical Testing Requirements - Is There Room for Compromise?
Leslie Hendeles, Pharm.D.
University of Florida, Gainesville, Florida, USA.
Clinical Requirements for New LABA/ICS Combinations in the USA.
Badrul A. Chowdhury, M.D., Ph.D.
Food and Drug Administration, Silver Spring, Maryland, USA.
What Do You Need to Measure to Establish Efficacy of New LABA/ICS Combinations for Submissions in the EU?
David Wright, Ph.D.
Medicines and Healthcare Products Regulatory Agency (MHRA), London, United Kingdom.
Clinical Demands for New LABA/ICS Combinations in Europe.
David Lyons, M.D.,
Irish Medicines Board, Dublin, Ireland
Clinical Development to Satisfy all Stakeholders. Who Might Give Way and On What?
Sanjeeva Dissanayake, M.D.,
Mundipharma, Cambridge, United Kingdom.
RDD Europe 2013 Panel Discussion
Chairperson and Advocate: Leslie Hendeles, Pharm.D., University of Florida, Gainesville, Florida, USA. Panel: Badrul Chowdhury, Food and Drug Administration; Sanjeeva Dissanayke, Mundipharma; David Lyons, Irish Medicines Board; David Wright, Medicines and Healthcare Products Regulatory Agency (MHRA);
During the Panel Discussion at RDD Europe 2013, Peter Byron (VCU), Gunther Hochhaus (University of Florida) and Michal Pirozynski (Orlowski Hospital) agreed to the inclusion of their questions and comments.
The podium presentations and discussion were recorded at Respiratory Drug Delivery 2010 in Orlando, Florida. This 2-hour session provides an overview of the current status of the phase-out of CFC MDIs followed by presentations highlighting the scientific, regulatory, political and commercial challenges that are associated with inhaler development in Article 5 countries including China and India. A lively panel discussion chaired by Professor Ashley Woodcock followed.
Complimentary copies of advocacy articles for each of the individual discussions are available online and as an attachment within each presentation. Articles are also included in Respiratory Drug Delivery 2010 Proceedings.
This free presentation has been made possible by the generous support of 3M Drug Delivery Systems.
Responsible Inhaler Development in Article V Countries: Navigating the Scientific, Regulatory, Political and Commercial Challenges.
Ashley Woodcock, M.D.
University of Manchester, Manchester, United Kingdom.
Inhaler Development in Developing Markets: Overcoming Barriers to Successful Implementation.
David J. Howlett, B.A.
PharmaDelivery Solutions, Grimston, United Kingdom.
Status, Challenges and Regulatory Strategies for Propellant Replacement in China.
Shuguang Hou, Ph.D.
3M Drug Delivery Systems, St. Paul, MN.
Inhalers for the Indian Subcontinent: Environmental and Therapeutic Imperatives.
Raj B. Singh, M.D.
Apollo Hospital, Chennai, India.
Respiratory Drug Delivery 2010 Panel Discussion
Chairperson: Ashley Woodcock, M.D., University of Manchester, Manchester, United Kingdom. Panel: Badrul A. Chowdhury, M.D. Ph.D., Food and Drug Administration; Shuguang Hou, Ph.D., 3M Drug Delivery Systems; David J. Howlett, B.A., PharmaDelivery Solutions; Fang Jin, Ph.D., Shanghai Institute of Pharmaceutical Industry; Raj. B. Singh, M.D., Apollo Hospital, India.
During the Panel Discussion at Respiratory Drug Delivery 2010, Peter Byron (VCU), Nelson Lago (Laboratorios Haymann), Mike Newhouse (McMaster University), John Pritchard (AstraZeneca), Charlie Thiel (Retired), Geraldine Venthoye (SkyePharma), and Patrick Yelverton (GlaxoSmithKline) agreed to the inclusion of their questions and comments.
Respiratory Drug Delivery 2010 in conjunction with the Product Quality Research Institute (PQRI) took an in-depth look at the potential for pharmacokinetics to serve as the sole in vivo metric necessary to support a finding of bioequivalence (BE) between inhaled products.
Expert opinions on this controversial issue were originally presented on April 29 and the speakers were joined in debate by FDA experts for a short panel discussion at the end of the formal presentations. Discussions on this topic continued on Friday April 30 in a PQRI coordinated Workshop and included case studies and a series of breakout sessions. Please visit www.pqri.org for further details.
This 3-hour presentation consists of a series of audio lectures and synchronized powerpoint slides. Complimentary copies of advocacy articles for each of the individual discussions are available online and as an attachment within each presentation. Articles are also included in Respiratory Drug Delivery 2010 Proceedings.
This free presentation has been made possible by the generous support of Product Quality Research Institute (PQRI).
Role of Pharmacokinetics in Establishing Bioequivalence for Orally Inhaled Drug Products.
Dennis O'Connor, B.S.
Boehringer Ingelheim, Ridgefield, CT.
Evolution of Regulatory and Scientific Paradigms for Establishing Equivalence of Systemic Exposure from Orally Inhaled Drugs: Current Status and Possible Challenges.
Gur Jai Pal Singh, Ph.D.
Scientific Advisor, Corona, CA.
Demonstrating Bioequivalence using Pharmacokinetics: Theoretical Considerations Across Drug Classes.
Guenther Hochhaus, Ph.D.
University of Florida, Gainesville, FL.
The Clinical Utility of Pharmacokinetics in Demonstrating Bioequivalence of Locally Acting OIPs.
Peter T. Daley-Yates, Ph.D.
GlaxoSmithKline, Uxbridge, United Kingdom.
Aspects of Pharmacokinetic Study Design to Differentiate Between Different Orally Inhaled Drug Products.
Lars Borgstrom, Ph.D.
AstraZeneca, Lund, Sweden.
Application of the EU Guidelines for Pharmacokinetic Studies of Locally Acting Orally Inhaled Drug Products.
Sanjeeva Dissanayake, M.R.C.P.
Medicines and Healthcare Products Regulatory Agency (MHRA), London, United Kingdom.
Panel Discussion
Panel: Dennis O'Connor, Boehringer Ingelheim; Gur Jai Pal Singh, Scientific Advisor; Guenther Hochhaus, University of Florida; Peter T. Daley-Yates, GlaxoSmithKline; Lars Borgstrom,
AstraZeneca; Sanjeeva Dissanayake, Medicines and Healthcare Products Regulatory Agency (MHRA).
During the Panel Discussion at Respiratory Drug Delivery 2010, Michael Newhouse, Thomas Hofmann, Stephen Newman, Xian-Ming Zeng, Colin Scott and Hartmut Derendorf agreed to the inclusion of their questions and comments.
Respiratory Drug Delivery 2008 featured a series of presentations and panel discussion focused on Quality by Design (QbD) and the possibility of using clinical data correlated with in vitro measurements (IVIVCs) to rationally set in vitro specifications for an inhaled product during development.
A complimentary copy of the advocacy article is available online and as an attachment within the presentation. The article is also included in Respiratory Drug Delivery 2008 Proceedings.
This free presentation has been made possible by the generous support of Respiratory Drug Delivery and Virginia Commonwealth University's Medical College of Virginia Foundation.
Panel Chairman: Peter R. Byron, Virginia Commonwealth University. Panel: Richard Ahrens, University of Iowa; Badrul Chowdhury, Food and Drug Administration; Prasad Peri, Food and Drug Administration; Terence Tougas, Boehringer Ingelheim; Omar Usmani, Imperial College, London; Marjolein Weda, NIPH Netherlands.
During the Panel Discussion at Respiratory Drug Delivery 2008, Chet Leach (Lovelace Respiratory Research Institute), Peter Villax (Hovione), Jolyon Mitchell (Trudell Medical International), Gur Jai Pal Singh (Watson Pharmaceuticals), Donovan Yeates (BioTechPlex), Steve Newman (Scientific Consultant), Xian-Ming Zeng (Teva Pharmaceuticals), Zhili Li (Transave) and Mike van Oort (GlaxoSmithKline) agreed to the inclusion of their questions and comments.
This 1-hour presentation features Dr. Peter R. Byron and a panel of distinguished scientists, recorded during RDD Europe 2007. It provides a broad perspective on the scientific, regional and global challenges of achieving and demonstrating bioequivalence between pulmonary drug delivery devices and formulations. The discussion covered topics such as the appropriateness of using reference listed products and useful biological endpoints to define bioequivalence.
A complimentary copy of the advocacy article is available online and as an attachment within the presentation. The article is also included in RDD Europe 2007 Proceedings.
This free presentation has been made possible by the generous support of Pfizer.
Discussion Leader: Peter R. Byron, Ph.D., Virginia Commonwealth University, Richmond, VA. Panel: Richard Ahrens, University of Iowa; Badrul Chowdhury, Food and Drug Administration; John Hall, Quintiles / John Hall Consulting; Caroline Vanneste, Health Canada; Gaetano Brambilla, Chiesi; Richard Malley, GlaxoSmithKline.
During the Panel Discussion at RDD Europe 2007, Martin Oliver (Vectura), Mark Everard (Sheffield Children's Hospital), Paul Atkins (Oriel Therapeutics), Gur Jai Pal Singh (Watson Labs) and Martin Grosvenor (AstraZeneca) agreed to the inclusion of their questions and comments.
The podium presentations and discussion were recorded at Respiratory Drug Delivery 2006 in Boca Raton, Florida to provide a broad perspective on 'Mitigating Producer Risk in a Highly Regulated Environment'. This 2-hour session adds to the debate on appropriate ways to assess the quality of inhaled pharmaceutical products.
Complimentary copies of advocacy articles for each of the individual discussions are available online and as an attachment within each presentation. Articles are also included in Respiratory Drug Delivery 2006 Proceedings.
This free presentation has been made possible by the generous support of Boehringer Ingelheim.
What does PAT mean for Inhalation Products?
Michael H. Golden, Ph.D.
GlaxoSmithKline, Research Triangle Park, NC
Audience discussion is included at the end of Dr Golden's presentation. Kevin Stapleton (Corus), Adrian Smith (Nektar) and Jagdeep Shur (University of Bath) agreed to the inclusion of their questions and comments.
Pharmaceutical Quality Assessment System (PQAS): Science and Risk Managed Approaches for Inhalation Drug Products
Guirag Poochikian, Ph.D.
Food and Drug Administration, Silver Spring, MD.
Audience discussion is included at the end of Dr Poochikian's presentation. Jackie Schumacher (Pfizer) and Robert Berger (Schering-Plough) agreed to the inclusion of their questions and comments.
Mitigating Producer Risk in a Highly Regulated Environment.
Peter R. Byron, Ph.D.
Virginia Commonwealth University, Richmond, VA.
OINDP Component Suppliers: Selection, Development and Control.
Barbara Falco, B.S.
Kos Pharmaceuticals, Edison, NJ.
Mitigating Producer Risk in a Highly Regulated Environment: Statistical Considerations
J. David Christopher, Ph.D.
Schering-Plough Research Institute, Kenilworth, NJ.
Ensuring OINDP Quality: International Perspectives.
Caroline Vanneste, Ph.D.
Health Canada, Ottawa, Canada.
Respiratory Drug Delivery 2006 Panel Discussion
Panel: Michael H. Golden, GlaxoSmithKline; Guirag Poochikian, Food and Drug Administration; Peter R. Byron, Virginia Commonwealth University; Barbara Falco, Kos Pharmaceuticals; J. David Christopher, Schering-Plough Research Institute; Caroline Vanneste, Health Canada.
During the Panel Discussion at Respiratory Drug Delivery 2006, Stephen Horhota (Boehringer Ingelheim), Michael Riebe (RTI), Craig Dunbar (Alkermes), Kevin Stapleton (Corus), Stefan Leiner (Boehringer Ingelheim), Elaine Phillips (Verus) and Manfred Keller (Pari) agreed to the inclusion of their questions and comments.
This 2-hour presentation was recorded at Respiratory Drug Delivery IX and presents FDA and industry expert viewpoints on how to decide which cascade impactor is most appropriate for testing in support of NDA and ANDA US regulatory submissions concerning inhaled products. This panel discussion from provides a broad perspective on the 'Selection and Validation of Cascade Impactor Test Methods', and stimulates debate on some of the major problems which require general resolution by the pharmaceutical industry.
Complimentary copies of advocacy articles for each of the individual discussions are available online and as an attachment within each presentation. Articles are also included in Respiratory Drug Delivery IX Proceedings.
This free presentation has been made possible by the generous support of Copley Scientific.
Selection and Validation of Cascade Impactor Test Methods
Peter R Byron
Virginia Commonwealth University
This presentation introduces the debate, and stimulates discussion about some of the major problems associated with the selection and validation of cascade impactor test methods.
Selection and Validation of Cascade Impactor Test Methods: Data Variability
Guirag Poochikian
Food and Drug Administration
This presentation provides the FDA's perspective on particle size distribution (PSD) methods and data variability. Factors which impact apparent PSD variability are addressed and illustrative examples provided alongside the discussion of data handling issues.
Perspectives on Validation of Cascade Impaction Methods
Harris Cummings
Cardinal Health
This presentation discusses the calibration of cascade impactors, specifically what 'calibration' means during routine impactor use. System suitability tests are discussed with ways of handling mensuration data for typical impactors.
Precision Limitations of the Andersen Mark II Cascade Impactor
Stephen W Stein
3M Drug Delivery Systems
This presentation reviews some of the factors controlling the limits of precision in the Andersen cascade impactor.
Andersen Cascade Impactor Specifications & Manufacture - Past and Present
Michael J Smurthwaite
Westech Instrument Services
This presentation reviews the history of the Andersen cascade impactor in the pharmaceutical industry, and explains some of the variability, changes and improvements seen with the ACI over the years.
Next Generation Impactor -what makes it a good impactor?
Keith G Truman
GlaxoSmithKline
The use of the Next Generation Pharmaceutical Impactor is advocated in this presentation. Factors and test method variables which influence final data variability from cascade impactors are also highlighted.
The European Pharmaceutical Aerosol Group NGI Collaborative Study
Steven C Nichols
Aventis
This presentation illustrates some of the results of the EPAG collaborative study which compared the NGI with the ACI, and also the MSLI.
RDD IX Panel Discussion
Panel Discussion Leader: Peter R Byron, Virginia Commonwealth University. Panel: Guirag Poochikian, Food and Drug Administration; Harris Cummings, Cardinal Health; Stephen W Stein, 3M Drug Delivery Systems; Michael J Smurthwaite, Westech Instrument Services; Keith G Truman,
GlaxoSmithKline; Steven C Nichols, Aventis.
This presentation includes slides from RDD Online to help summarize the Panel Discussion at Respiratory Drug Delivery IX. By participating in the panel discussion, John Simons (3M Drug Delivery Systems), Craig Dunbar (Alkermes), Nick Miller (for MSP Corporation), Jolyon Mitchell (Trudell Medical International), Nani Kadrichu (Nektar Therapeutics), Shyamala Ivatury (PPD Development) and Chris Shelton (Cardinal Health) agreed to permit the inclusion of their questions and comments in this presentation.
