Poster Sessions

Bioanalytical Systems, Inc. (BASi)
Tuesday, Nov. 10, 8:00 am - noon
Determination of Carbamazepine and Four Metabolites in Porcine Plasma Using LC-MS/MS
Authors: H. G. Jayaratna, B. Engel, J. Torchia, R. Tyler DeGraw, BASi

Camargo Pharmaceutical Services
Tuesday, Nov. 10, 8:00 am - noon
CMC for 505(b)(2) Applications
Authors: Lynn Gold, Ph.D., Ken Phelps, Kathryn Wekselman, Ph.D., RN, and Karen Seta-Aust, Ph.D. of Camargo Pharmaceutical Services

Wednesday, Nov. 11 - 8:00 a.m. - noon
Pharmacokinetic (PK) Modeling & Steady-State Simulations: Strategic Use in a 505(b)(2) Drug Development Program
Authors: Stacey Ayres, PhD and Ruth Stevens, PhD, MBA Camargo Pharmaceutical Services, LLC, Sunny Tse Oregon State University

Catalent Pharma Solutions
Monday, Nov. 9
Rapid, Cost-Effective Technical Transfer of cGMP Manufacturing Processes to Produce Sterile Clinical Trial Materials.
Authors: JJ Luo, Ph.D., Brian Woodrow, Ph.D., Craig Davies-Cutting, Ph.D., Wally Brisson, MBA, and Daniel Wendt, Ph.D. (all from Catalent Pharma Solutions)

Fast into Man Model for Dry Powder Inhaler (DPI) Development
Authors: Lei Mao, LaMonica Ware, Lani Kroopnick, David Hall, Kerry Eischen, Tyson Anderson, Briana Pridgen, and Craig Davies-Cutting, Ph.D. (all from Catalent Pharma Solutions)

Tuesday, Nov. 10
Validation of a Moisture Determination for Pressurized Metered Dose Inhalers—An Alternative Approach
Authors: Brian Woodrow, Ph.D., Michael Ruffin, Tristan Fairbrother and Courtney Moore.

Effect of Plasticizer Type on Long-Term Stability of Enteric Coated Softgels.
Authors: Irena McGuffy and Stephen Tindal of Catalent Pharma Solutions, along with Kai Zhuang and Nigel Langley of BASF.

Jeffrey Browne, Ph.D. of Catalent will participate in a roundtable discussion on "The Pros and Cons of Development Approaches to Poorly Soluble Compounds (In-House Development and Manufacture vs. Outsourcing)."

Wednesday, Nov. 11
Detection of Residual Solvents in a Large-Molecule API by 1H NMR Spectroscopy
Author: Charlotte Carol, Catalent Pharma Solutions

Detection of Adulterants in Raw Materials, Drug Substances, and Products by NMR Spectroscopy
Author: Michelle Derider, Catalent Pharma Solutions

Thursday, Nov. 12
Gelatin-free Softgel Studies: Development of Novel Shell Compositions and Processes Suitable for the 'Hot Filling' of High Viscosity and Semi-solid Fill Materials
Authors: Norman Stroud, Keith Tanner, Elizabeth Youngblood, Didier Kiyali and Shawn McKee (all from Catalent Pharma Solutions)

DPT
Thursday, Nov. 12 - 8:00 am - noon
Enhancing the Solubility of Poorly Water Soluble Drugs in the Presence of Nano-Emulsion Particles

Impact Analytical
Monday Nov. 9th, 2:00-3:30 p.m.
Presentation in seminar room #1: “Root Cause Investigations for Product Quality and Regulatory Compliance: Techniques, Strategies, and Partners.”
Presented by Eric Hill, Business Marketing Manager, Impact Analytical (Booth 2755), and Jason Clevenger, Managing Scientist, Exponent, Inc. (Booth 2757)

MDS Pharma Services
Tuesday, Nov. 10, 8:00 a.m. - noon
A Highly Sensitive Method for the Quantitation of Testosterone and Dihydrotestosterone in Human Serum via LC-MS/MS
Authors: Ginny B. James, Ridha Nachi, Jonathan O. Rathe, Chris J. Kafonek, Curtis E. Sheldon, Chad J. Briscoe (all of MDS Pharma Services)

A High throughput Selective and Sensitive Method for the Quantitation of Niacin, Nicotinamide and Nicotinuric acid Human EDTA Plasma via LC-MS/MS
Authors: C. Sheldon, V. Lapko, J. Rollag, A. Dzerk, R. Nachi, C. Kafonek, C. Briscoe (all of MDS Pharma Services)

Metrics Inc.
Monday, Nov. 9
The Case Against Powder (Active Only) in Capsule Phase I Formulations for Poorly Soluble Drugs: A Comparison of In-Vitro Dissolution
Author: Dr. Michael Ruff, CPIP, vice president of pharmaceutical development, Metrics, Inc.

pION
Tuesday, Nov. 10, 1:00 p.m. - 5:00 p.m.
High Throughput Assay for Pre-Selecting Excipients Enhancing Solubility of Low Soluble Compounds

Miniaturization of Powder Dissolution Measurement and Estimation of Particle Size

Wednesday, Nov. 10, 1:00 p.m. - 5:00 p.m.
Prediction of in situ Blood-Brain Barrier Permeability using BBB PAMPA Model

Qualicaps
Mini-seminars at Booth 1101

Monday, Nov. 9 at 3:00 – HPMC Capsule Development

Tuesday, Nov. 10 at 10:00 – HPMC Capsule Development

Tuesday, Nov. 10 at 3:00 – Liquid‐Filling

Wednesday, Nov. 11 at 10:00 – Liquid‐Filling

Wednesday, Nov. 11 at 2:00 – HPMC Capsule Development

Authors: Brian Jones, co‐author of Pharmaceutical Capsules, Fernando Diez, technical expert from Qualicaps Europe, and Shannon Putnam, director of the machinery division at Qualicaps, Inc.

SNBL USA
Duration of meeting

Determination of β-Adrenoceptor Antagonist d,l-Sotalol in Cynomolgus Monkey Plasma by Liquid Chromatography-Multiple Reaction Monitoring LC-MS/MS
Author: Rajsharan (Sharon) Rana, senior analytical chemist, SNBL USA

The McCrone Group
Tuesday, Nov. 10 from 8:00 a.m. - noon
Digital Photomicrography of Pharmaceutical Contamination
Author: Kristen Partin, Research Microscopist, The McCrone Group

Glass Delamination of Pharmaceutical Vials
Author: Kristie Diebold, research microscopist, The McCrone Group

West Pharmaceutical Services
Wednesday, Nov. 11, 1:00-5:00 p.m.
Vacuum Retention in Vial-Stopper Systems: A Study on Component Compatibility
Author: Jeff Smythe (West Pharmaceutical Services)