2015 Conference Presentations

<< All Conferences
<< Past Conferences

Click on each title to access the presentation

Thursday, April 30 - AM

Lucinda BuhseLucinda Buhse, Ph.D




Lawrence YuLawrence Yu, Ph.D
Office of Pharmaceutical Quality: Why, What, and How?




Vadim GurvichVadim Gurvich, Ph.D
NIPTE: A Decade of Excellence in
Pharmaceutical Science and Education



Robert LionbergerRobert Lionberger, Ph.D.
Pharmaceutical Science for Generic Drugs: The Science of Equivalence


Ajaz HussainAjaz Hussain, Ph.D.
Looking Forward: Beyond 2015
NIPTE Research Conference: Pharmaceutical Critical Path Manufacturing -2015


Thursday, April 30 - Afternoon

Mansoor KahnMansoor Khan, Ph.D.
Enhancing confidence in Pharmaceutical, Biological, and Therapeutic Equivalence



Gregory AmidonGregory Amidon, Ph.D.
Impact of Buffer on Dissolution: In vivo Relevance




Lee KirschLee 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 BerklandCory Berkland, Ph.D.




Nashwa Abd El-Hamid El-GendyNashwa Abd El-Hamid El-Gendy, Ph.D
Determination of Local Concentrations of Bupivacaine Using MicrodialysisTechniques


Thursday, April 30 - PM

Katherine TynerKatherine Tyner, Ph.D.
Drug Delivery System Development



Stephen HoagStephen Hoag, Ph.D.
Methods for the Assessment of Cold Flow in Matrix Transdermal Drug Delivery Systems



Maureen DonovanMaureen Donovan, Ph.D.
In Vitro Assessment of Nasal Deposition Patterns in the Pediatric Population



Bodhi ChaudhuriBodhi Chaudhuri, Ph.D.
Electrostatic Behavior in Granular Materials

Friday, May 1 - AM

Steve KozlowskiSteve Kozlowski, Ph.D.
CMC Considerations to Support Demonstration of Biosimilarity



Alina AlexeenkoAlina Alexeenko, Ph.D.
Insights from In Silico Analysis for Improved Lyophilization Processes and Systems




Thomas Tolbert

David VolkinChristian Schoneich




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 BognerRobin Bogner, Ph.D.
Variation in Pressure Within the Drying Chamber and Impact on Freeze-Drying Design Space


Anna SchwendermanAnna Schwendeman, Ph.D.
Physicochemical Characterization of Remicade®
and its Biosimilar RemsimaTM




Friday, May 1 - Afternoon

Larry Sau LeeLarry Sau Lee, Ph.D.
Manufacturing of Pharmaceutical Solids:Challenges and Opportunities


Lynne TaylorLynne Taylor, Ph.D.




Paul SchmittPaul Schmitt
Detection and Quantification of Trace Crystallinity in Amorphous Formulations Using Second Harmonic Generation (SHG) Microscopy




Lian YuLian Yu, Ph.D.
Pharmaceutical co-crystals and their anomalous formation properties



Zoltan NagyZoltan Nagy, Ph.D.
Development of Real-Time Release
Continuous Crystallization System with Anti-
Fouling Control



Friday, May 1 - PM

Chirstine M V MooreChirstine M. V. Moore, Ph.D.
Pharmaceutical Manufacturing –Introductory Remarks



Rohit RamachandranRohit Ramachandran, Ph.D.
2015 Mechanistic modeling of mixer-granulator processes: toward QbD



Peter WildfongPeter Wildfong, Ph.D.
Characterization of Complex Mixtures



Warren RoseWarren Rose, Ph.D.
Sterilization Process Development for pre-Operative Antiseptic Products



Raj SuryanarayananEric Munson

Raj Suryanarayanan, Ph.D. & Eric Munson, Ph.D.
Evaluation of Polymorphic Changes During Tablet Manufacturing and Storage