Scientific papers

Name	PresentedAt/PresentedBy	FileType	Size
Considerations & Approaches for Filling Dry Powder Inhalers (DPIs)	Presented at/by: Management Forum – Dry Powder Inhalers (London). Craig Davies-Cutting, Ph.D.	pdf	435 KB
Validation of Moisture Determination for Pressurized Metered Dose Inhalers - An Alternative Approach	Brian N. Woodrow, Ph.D., Tristan Fairbrother, Tony Ruffin, and Courtney Turner	pdf	39 KB
Standardizing Phase Appropriate Validation of GMP Potency Bioassays	Ana T. Menendez, Ph.D.	pdf	1292 KB
Rapid, Cost-Effective Technical Transfer of cGMPManufacturing Processes to Produce Sterile Clinical Trial Materials	J. J. Luo, Ph.D., Brian N. Woodrow, Ph.D., Craig Davies-Cutting, Ph.D., Wally Brisson, MBA, Dan Wendt, Ph.D.	pdf	163 KB
Overcoming Free Drug and Matrix Effects in Detecting Antibodies to a Derivatized Protein	Valerie Stratico, M.S., Ana T. Menendez, Ph.D.*, Gwendolyn Wise-Blackman, Ph.D.	pdf	689 KB
Overcoming Assay Drift and Multiple Matrix Interference Challenges in a PK ELISA	Simone S. Cummings*, Ph.D., Gwendolyn Wise-Blackman, Ph.D	pdf	1026 KB
novel High-Throughput Method for the Separation of a Derivatized Protein from it's Unmodifed Form in Serum	Joseph J. Lundquist, Ph.D., Ana T. Menendez, Ph	pdf	639 KB
Gelatin-free Softgel Studies: Development of Novel Shell Compositions and Processes Suitable for the 'Hot Filling' of High Viscosity and Semi-solid Fill Materials	Norman Stroud, Keith Tanner, Elizabeth Youngblood, Didier Kiyali, and Shawn McKee	pdf	232 KB
Fast into Man Model for Dry Powder Inhaler (DPI) Development	Lei Mao, Ph.D.,LaMonica Ware, Lani Kroopnick, David Hall, Kerry Eischen, Tyson Anderson, Briana Pridgen, Craig Davies-Cutting, Ph.D.	pdf	79 KB
Effect of Plasticizer Type on Long -Term Stability of Enteric Coated Softgels	I. McGuffy1, K. Zhuang2, S. Tindal1, N. Langley2 (1 = Catalent Pharma Solutions & 2 = BASF Corporation)	pdf	155 KB
Detection of Residual Solvents in a Large-Molecule API by 1H NMR Spectroscopy	Charlotte A. Carroll, Andrew C. Kolbert, and Tom Feinberg	pdf	74 KB
Detection of Adulterants in Raw Materials, Drug Substances, and Products by NMR Spectroscopy	Charlotte A. Carroll, Michele L. DeRider, and Thomas N. Feinberg	pdf	215 KB
A Novel Immunogenicity Assay Using the Affibody® Ligand can Overcome Inherent Control Challenges	Biological Assay Development & Validation/Jayne A. Keifer	pdf	1756 KB