AAPS Workshop on Role of Dissolution in QbD and Drug Product Life Cycle
April 28 - 30, 2008
Hyatt Regency
Crystal City, VA
Co-Sponsored by: The U.S. Food and Drug Administration

Part 1 (mp3 audio)

Part 2 (mp3 audio)

Part 3 (mp3 audio)

Part 4 (mp3 audio)

Part 5 (mp3 audio)

Sunday, April 27, 2008

5:00 pm – 7:00 pm
Registration

Monday, April 28, 2008

7:00 am – 5:00 pm
Registration

8:00 am - 12:15 pm
Role of Dissolution in QbD and Product Development Continuum
Moderators
Helen Winkle
U.S. Food and Drug Administration

Tahseen Mirza, Ph.D.
Novartis Pharmaceutical Corporation

8:00 am
Agenda Overview
Tahseen Mirza, Ph.D.
Novartis Pharmaceutical Corporation

8:05am
Regulatory Modernization and Its Impact on Dissolution
Helen Winkle
U.S. Food and Drug Administration

9:00 am
Dissolution Challenges in Product Development – An Academic Perspective
James Polli, Ph.D.
University of Maryland

9:35 am Independence Center
Coffee Break/Exhibits

10:10 am
Dissolution Challenges in Product Development – A Branded Industry Perspective
Tahseen Mirza, Ph.D.
Novartis Pharmaceutical Corporation

10:50 am
Challenges in Dissolution Testing and Setting Specification for Generic Drugs
Saji Thomas
Par Pharmaceutical

11:30 am
Panel Discussion

12:15 pm
Lunch/Exhibits
Complimentary to all attendees

1:15 pm – 5:00 pm
Role of Dissolution in QbD
Moderators
Ruben Lozano, Ph.D.
Bristol-Myers Squibb Company

John Smith, Ph.D.
U.S. Food and Drug Administration

1:15 pm
QbD and Its Relevance to Dissolution/Drug Release
Arzu Selen, Ph.D.
U.S. Food and Drug Administration

2:00 pm
Establishing the Clinical Relevance of Dissolution Testing During Quality-by-Design
Paul Dickinson, Ph.D.
AstraZeneca

2:30 pm
Using PAT to Investigate the Dissolution Mechanism of Dilantin
Stephen Hammond, Ph.D.
Pfizer, Inc.

3:00 pm
Coffee Break/Exhibits

3:15 pm
QbD to the Rescue: Two Case Studies
John J. Glennon
GlaxoSmithKline

3:45 pm
Application of Performance Test in Drug Product Development Using Quality by Design Approach – Varenicline Case Study
Kyle Bui
Vertex Pharmaceuticals Inc.

4:15 pm
Panel Discussion

5:00 pm
Reception/Exhibits

Tuesday, April 29, 2008

7:00 am – 5:30 pm
Registration

8:00 am – 12:00 pm
Relevance of Dissolution in Drug Development
Moderators
Qingxi (Charles) Wang, Ph.D.
Merck and Company

Arzu Selen, Ph.D.
U.S. Food and Drug Administration

8:00 am
Relevance of Physico-chemical Characteristics in Dissolution and Product Development
Abu Serajuddin, Ph.D.
Novartis Pharmaceutical Corporation

8:30 am
Roles of Modeling and Simulation in Dissolution Method Development
John Crison, Ph.D.
Simulations Plus

9:00 am
Roles of Dissolution in Predicting Food Effect
Jean M. Surian, Ph.D.
AstraZeneca Pharmaceuticals, LP

9:30 am
Novel Dissolution Concepts at the Research and Development Interface
Sudhakar Garad, Ph.D.
Novartis Pharmaceutical Corporation

10:00 am
Coffee Break/Exhibits

10:30 am
Roles of Bio-relevant Dissolution for Early Phase Formulation Development
Yun Mao, Ph.D.
Merck and Company

11:30 am
Roles of Dissolution in Generic Drug Development
Wantanee Phuapradit, Ph.D.
Barr Laboratories

12:00 pm – 1:15 pm Independence Center
Lunch/Exhibits
Complimentary to all attendees

1:15 pm – 5:30 pm Regency Ballroom EF
IVIVC/R
Moderators
Vivian Gray
V.A. Gray Consulting

Mansoor Khan, Ph.D.
U.S. Food and Drug Administration

1:15 pm
Developing IVIVC using Dynamic Dissolution and Computer Simulations with Gastro Plus™
Raimar Lobenberg, Ph.D.
University of Alberta

1:45 pm
Linking In Vitro Dissolution Test and In Vivo Performance for Sustained Release Dosage Form – A Case Study
Cheng (Charles) Tong, Ph.D.
Pfizer, Inc.

2:15 pm
IVIVC for Sustained Release Product
Richard Saunders, Ph.D.
Wyeth Pharmaceuticals

3:00 pm Regency Ballroom Foyer
Coffee Break

3:15 pm
The Use of Biorelevant Dissolution Media to Forecast the In Vivo Performance of a Drug
Sandra Klein, Ph.D.
Goethe University

3:45 pm
BCS Biowaiver Extension: Role of Dissolution
Lawrence Yu, Ph.D.
U.S. Food and Drug Administration

4:15 pm
Panel Discussion

5:15 pm
Wrap-up of Day 2
Vivian Gray
V.A. Gray Consulting

Mansoor Khan, Ph.D.
U.S. Food and Drug Administration

Wednesday, April 30, 2008

7:00 am – 12:30 pm Regency Ballroom Foyer
Registration

8:00 am – 12:30 pm Regency Ballroom EF
Dissolution: Hot Topics

Moderators
Stephen Mayock
Catalent Pharma Solutions

William Brown
U.S. Pharmacopeia

8:00 am
USP Perspective
William Koch, Ph.D.
U.S. Pharmacopeia

8:30 am
Dissolution Challenges in Fixed Combination Products
Joseph Etse, Ph.D.
Novartis Pharmaceutical Corporation

9:00 am
Pharmaceutical Cocrystals – Realizing the Benefits of Novel Forms
Jeffrey A. Lindeman, Ph.D., Esq.
Nixon Peabody LLP

9:30 am Regency Ballroom Foyer
Coffee Break

10:00 am
Disintegration Test as a Surrogate for Dissolution: Some Practical Considerations
Vilayat Sayeed, Ph.D.
U.S. Food and Drug Administration

10:30 am
Alcohol Effect on Extended Release Solid Oral Dosage Form
Eric Duffy, Ph.D.
U.S. Food and Drug Administration

11:00 am
QbD Perspectives on Dose Dumping with Alcohol
Mansoor Khan, Ph.D.
U.S. Food and Drug Administration

11:30 am
Panel Discussion

12:00 pm
Wrap-up
Tahseen Mirza, Ph.D.
Novartis Pharmaceutical Corporation

12:30 pm
Adjournment