An agenda and webinar recordings for "In Vitro Dissolution Profiles Similarity Assessment in Support of Drug Product Quality: What, How, and When" are provided below for the convenience of event attendees.
This two-day workshop was held May 21-22, 2019, at the University of Maryland School of Pharmacy, located at 20 N. Pine Street in Baltimore, Md.
Download a printer-friendly agenda here.
Conference Recordings:
Explore the links below to view webinar recordings filmed during "In Vitro Dissolution Profiles Similarity Assessment in Support of Drug Product Quality: What, How, and When."
Please note that each recording begins prior to speaker starting.
| Conference Webinar Recordings | |
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| May 21 |
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| May 22 |
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Conference Agenda:
Tuesday, May 21, 2019
Moderators: Dorys Diaz (Pfizer) and David LeBlond (CMCStats)
| Time | Activity |
|---|---|
| 8:30-8:35 a.m. | Welcome and Logistics James Polli, PhD University of Maryland School of Pharmacy |
| 8:35-8:50 a.m. | Introduction and Objectives of the Workshop Sandra Suarez, PhD U.S. Food and Drug Administration |
| 8:50-9:20 a.m. | Keynote: The Value of Similarity Testing in Drug Product Development Roger Nosal, PhD Pfizer |
| 9:20-9:50 a.m. | F2 Similarity Testing, Performance and Limitations Yi Tsong, PhD U.S. Food and Drug Administration |
| 9:50-10:20 a.m. | Bootstrap Approach for Similarity Testing, Performance and Limitations Leslie Van Alstine, MS Pfizer |
| 10:20-10:30 a.m. | Break |
| 10:30-11:00 a.m. | Mahalanobis Distance Based Approaches, Performance and Limitations Thomas Hoffelder Boehringer-Ingelheim |
| 11:00-11:30 a.m. | Bayesian Approach for Similarity Testing, Performance and Limitations Dave LeBlond, PhD CMCStats |
| 11:30 a.m. - Noon | Weibull Model Approach for Similarity Testing, Performance and Limitations Stan Altan, PhD Johnson & Johnson |
| Noon – 12:45 p.m. | Lunch |
| 12:45-1:15 p.m. | Rational Statistical Analysis Practice in Dissolution Profile Comparison: FDA Perspective Haritha Mandula, PhD U.S. Food and Drug Administration |
| 1:15-1:45 p.m. | Rational Statistical Analysis Practice in Dissolution Profile Comparison for Product Quality Assessment of Similarity through Real Case Studies: Industry Perspective Yanbing Zheng, PhD AbbVie |
| 1:45-2:00 p.m. | Introduction and Expectations of Breakout Sessions (BOs) Dave LeBlond, PhD CMCStats BO Sessions, Background Topic: Advantages and Disadvantages of Available Statistical Approaches to Dissolution Profile Comparisons for Similarity Testing |
| 2:00-2:15 p.m. | Break and Transition to BOs |
| 2:15-4:15 p.m. | Breakout Sessions (Choose One to Attend) BO Session A: Definition/Discussion of Similarity Terminology -- How Should "Similarity" Be Most Usefully Defined? Moderators: Dave LeBlond (CMCStats), Thomas Hoffelder (Boehringer-Ingelheim) Scribes: Haritha Mandula (FDA), Limin Zhang (BMS) View Presentation Slides BO Session B: Best Practices for Performing Dissolution Similarity for Regulatory Applications Moderators: Elena Rantou (FDA), Krista Witkowski (Merck) Scribes: Poonam Delvadia (FDA), Karin Rosenblatt (AbbVie) View Presentation Slides BO Session C: What is the Proper "Inference Space" for Similarity Studies? Addressing This is Key to Experimental Design BO Session D: What Are the Advantages and Disadvantages of Currently Available "Statistical" Approaches for Dissolution |
| 4:15-4:45 p.m. | Break (Moderators and Scribes to Convene) |
| 4:45-5:30 p.m. | Summary of Breakout Sessions Lead Moderators |
| 5:30-6:15 p.m. | OC Members/Moderators/Scribes |
Wednesday, May 22, 2019
Moderators: Andreas Abend (Merck), Poonam Delvadia (FDA), and Sandra Suarez (FDA)
| Time | Activity |
|---|---|
| 8:30-8:35 a.m. | Welcome and Logistics Poonam Delvadia, PhD U.S. Food and Drug Administration |
| 8:35-9:10 a.m. | FDA's Current Practice and Challenges in the Evaluation of Dissolution Profile Comparisons in Support of Minor/Moderate Product Quality Changes: Case Studies Om Anand, PhD U.S. Food and Drug Administration |
| 9:10-9:40 a.m. | EMA's Current Practice and Challenges in the Evaluation of Dissolution Profile Comparisons in Support of Minor/Moderate Product Quality Changes: Case Studies Evangelos Kotzagiorgis, MSc European Medicines Agency |
| 9:40-10:10 a.m. | Dissolution Similarity Applications in New Drug Product Development -- Issues and Challenges: Case Studies Limin Zhang, MS Bristol-Myers Squibb |
| 10:10-10:40 a.m. | ANVISA's Current Practice and Challenges in the Evaluation of Dissolution Profile Comparisons in Support of Minor/Moderate Product Quality Changes: Case Studies Victor Gomez Pereira, PhD Anvisa |
| 10:40-11:00 a.m. | Break |
| 11:00-11:30 a.m. | Health Canada's Current Practice and Challenges in the Evaluation of Dissolution Profile Comparisons in Support of Minor/Moderate Product Quality Changes: Case Studies Susan Lum, PhD Health Canada |
| 11:30 a.m. - Noon | FDA's Current Challenges in the Use of Dissolution Similarity Testing for Demonstration of BE: Case Studies Zhen Zhang, PhD U.S. Food and Drug Administration |
| Noon - 12:30 p.m. | Dissolution Similarity Applications in Generic Industry -- Issues and Challenges: Case Studies Emilija Fredro-Kumbaradzi, PhD Apotex |
| 12:30-12:45 p.m. | Introduction and Expectation of BO Sessions Andreas Abend, PhD Merck BO Sessions, Background Topic: Dissolution Similarity Assessment, Requirements, and Global Expectations |
| 12:45-1:30 p.m. | Lunch |
| 1:30-3:30 p.m. | Breakout Sessions (Choose One to Attend) BO Session A: The Value of Similarity Testing in Light of Clinically Relevant Specifications and Safe Space Moderators: Sandra Suarez (FDA), Gregory Rullo (AZ) Scribes: Elisabeth Kovacs, Andreas Abend (Merck) View Presentation Slides BO Session B: Dissolution Similarity Assessment, Requirements, and Global Expectations Moderators: Johannes Kraemer (Disso-Science), Susan Lum (Health Canada) Scribes: Amy Barker (Lilly), Kelly Kitchens (FDA), Xin Bu (BMS) View Presentation Slides BO Session C: How to Design a Robust Statistical Approach (e.g., Decision Tree) for the Assessment of Dissolution Profile Comparisons -- Part 1 Moderators: Yanbing Zheng (AbbVie), Meiyu Shen (FDA) Scribes: Om Ananda (FDA), Ivelisse Colon-Rivera (Vertex) View Presentation Slides BO Session D: How to Design a Robust Approach (e.g., Decision Tree) Beyond Statistical Considerations for the Assessment of Dissolution Profile Comparisons -- Part 2 Moderators: Poonam Delvadia (FDA), David Lavrich (Merck), Amy (Huizi) Zhang (GSK) Scribes: Dave LeBlond (CMCStats), Michael Cohen (Pfizer), Gao Yi (AbbVie) View Presentation Slides |
| 3:30-4:00 p.m. | Break (Moderators/Scribes to Convene) |
| 4:00-4:45 p.m. | Summary of Breakout Sessions Lead Moderators |
| 4:55-5:15 p.m. | Conclusion and Future Directions Dorys Diaz, MBA Pfizer |