2015 Conference Presentations

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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