Scientific Design of Pharmaceutical Products

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Scientific Design of Pharmaceutical Products - Day 1

Abuse Deterrence is a Critical Quality Attribute
Stephen R. Byrn, Ph.D.

Clinical Relevance of Drug Releases Testing
James Polli, Ph.D.

Gabapentin - Optimizing Design Space Specifications Across Scales with Considerations to Stability: US-FDA Sponsored Case Study
L. E. Kirsch

OPQ Science and Research for Supporting Drug Quality Evaluation, Standards and Policy
Michael Kopcha, Ph.D., R.Ph.

Pharmaceutical Technology, Education and Confidence in Assurance of Quality
Ajaz S. Hussain, Ph.D.

Progressing Innovation in Manufacturing Science
Patrick Marsac, Ph.D.

A QbD Approach to Process Development: Defining Critical Quality Attributes and Evaluating Criticality Across Scales
Carl A. Anderson, Ph.D.

Scientific Design of Pharmaceutical Products - Day 2

Computational Modeling for Improved Lyophilization Process Understanding and Scale-Up
Alina A. Alexeenko

Continuous Manufacturing and Design Space
Marianthi Ierapetritou

Development of a Risk-Based Design Space for Freeze Drying
Robin H. Bogner

FDA Experience with Continuous Manufacture
Celia N. Cruz, Ph.D.

Formulation Design Considerations for Continuous Manufacturing With Real-Time Release
James K. Drennen III

The Importance of Product Characterization to Demonstrating Equivalence for Complex Drug Products
Sam Raney, Ph.D.

Material Characterization and Control and Knowledge Management Considerations for Continuous Manufacturing with the Real-Time Release
Stephen W. Hoag, Ph.D.

NIPTE’s Interest and Efforts to Support Integrated Scientific Development of Pharmaceutical Products
Eric Munson, Ph.D.

Objective Risk Assessment via Asking the Right Question at the Right Time
Kenneth Morris, Ph.D.