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Short Course 4: Predictive Dissolution Modeling: Next-Generation Development and Release Strategy

Short Course

8:00 AM–4:00 PM Nov 12, 2017

San Diego Convention Center - Room 28DE

Description

Moderators:

  • Zhenqi P. Shi Ph.D.

Proposal Description:

An additional fee is required to attend this short course. To register, visit www.aaps.org/AMRegister

Predictive dissolution modeling is an emerging technology that promises to streamline product testing, improve product quality and reduce product waste. The ability to predict dissolution profiles based on models utilizing material properties, process conditions, and/or in-process measurements was demonstrated in the literature many years ago. Despite this, there are relatively few examples of predictive dissolution models being used in a quality control environment and even fewer examples in real-time release situations. There are relatively more examples in the product development space, but even in these cases there is no standard or well accepted approach that the industry has adopted. As a result, there is a general knowledge gap of the best methods and techniques to utilize for predictive dissolutions models. This short course will cover the current approaches, experiences, and thinking in predictive dissolution modeling, including case studies with successes and failures from academia, health authorities, and industry. Among industrial participation, summarized learnings across multiple companies will be shared on how first principle and empirical approaches have been used for development, understanding, as well as real-time release. In addition to the presentations, the attendees will be encouraged to participate through discussion and question and answer sessions.

Learning Objectives:
•Increase public awareness of the approaches (empirical and/or first-principles driven) to predictive dissolution modeling and its application for real-time release testing (RTRt)
•Engage industry interactions on understanding the incentives and reluctances to conducting predictive dissolution modeling with the intent to promote more in-silico modeling for drug product development and routine release testing in manufacturing
•Engage regulatory interactions on establishing the best practices of predictive dissolution modeling

Sub-Sessions
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Short Course

Overall Introduction

8:00 AM–8:15 AM Nov 12, 2017

San Diego Convention Center - Room 28DE

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Short Course

Beverage Break

9:45 AM–10:00 AM Nov 12, 2017

San Diego Convention Center - Room 28DE

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Short Course

Brain-storming Session

10:00 AM–11:00 AM Nov 12, 2017

San Diego Convention Center - Room 28DE

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Short Course

Buffet Lunch (Short Course Attendees only)

11:00 AM–12:00 PM Nov 12, 2017

San Diego Convention Center - Room 28DE

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Short Course

Beverage Break

2:15 PM–2:30 PM Nov 12, 2017

San Diego Convention Center - Room 28DE

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Short Course

Open Discussion and Wrap Up

3:15 PM–4:00 PM Nov 12, 2017

San Diego Convention Center - Room 28DE

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