Thursday, April 30 - AM
Lucinda Buhse, Ph.D
Lawrence Yu, Ph.D
Office of Pharmaceutical Quality: Why, What, and How?
Vadim Gurvich, Ph.D
NIPTE: A Decade of Excellence in
Pharmaceutical Science and Education
Robert Lionberger, Ph.D.
Pharmaceutical Science for Generic Drugs: The Science of Equivalence
Ajaz Hussain, Ph.D.
Looking Forward: Beyond 2015
NIPTE Research Conference: Pharmaceutical Critical Path Manufacturing -2015
Thursday, April 30 - Afternoon
Mansoor Khan, Ph.D.
Enhancing confidence in Pharmaceutical, Biological, and Therapeutic Equivalence
Gregory Amidon, Ph.D.
Impact of Buffer on Dissolution: In vivo Relevance
Lee Kirsch, Ph.D.
Initial Studies on the Use of Particle Size Distribution Overlap Metrics to Evaluate Release Rate Equivalency for Disperse System Drug Products
Cory Berkland, Ph.D.
Nashwa Abd El-Hamid El-Gendy, Ph.D
Determination of Local Concentrations of Bupivacaine Using MicrodialysisTechniques
Thursday, April 30 - PM
Katherine Tyner, Ph.D.
Drug Delivery System Development
Stephen Hoag, Ph.D.
Methods for the Assessment of Cold Flow in Matrix Transdermal Drug Delivery Systems
Maureen Donovan, Ph.D.
In Vitro Assessment of Nasal Deposition Patterns in the Pediatric Population
Bodhi Chaudhuri, Ph.D.
Electrostatic Behavior in Granular Materials
Friday, May 1 - AM
Steve Kozlowski, Ph.D.
CMC Considerations to Support Demonstration of Biosimilarity
Alina Alexeenko, Ph.D.
Insights from In Silico Analysis for Improved Lyophilization Processes and Systems
Thomas J. Tolbert, Ph.D., David B. Volkin, Ph.D., Christian Schöneich, Ph.D. Project Title: Physicochemical and biological evaluations of different IgG1 Fc glycoforms
Robin Bogner, Ph.D.
Variation in Pressure Within the Drying Chamber and Impact on Freeze-Drying Design Space
Anna Schwendeman, Ph.D.
Physicochemical Characterization of Remicade®
and its Biosimilar RemsimaTM
Friday, May 1 - Afternoon
Larry Sau Lee, Ph.D.
Manufacturing of Pharmaceutical Solids:Challenges and Opportunities
Lynne Taylor, Ph.D.
Detection and Quantification of Trace Crystallinity in Amorphous Formulations Using Second Harmonic Generation (SHG) Microscopy
Lian Yu, Ph.D.
Pharmaceutical co-crystals and their anomalous formation properties
Zoltan Nagy, Ph.D.
Development of Real-Time Release
Continuous Crystallization System with Anti-
Friday, May 1 - PM
Chirstine M. V. Moore, Ph.D.
Pharmaceutical Manufacturing –Introductory Remarks
Rohit Ramachandran, Ph.D.
2015 Mechanistic modeling of mixer-granulator processes: toward QbD
Peter Wildfong, Ph.D.
Characterization of Complex Mixtures
Warren Rose, Ph.D.
Sterilization Process Development for pre-Operative Antiseptic Products
Raj Suryanarayanan, Ph.D. & Eric Munson, Ph.D.
Evaluation of Polymorphic Changes During Tablet Manufacturing and Storage