Publication entries for in vitro
William H. Doub1, Vibhaker Shah2, Susan Limb3, Changning Guo1, Xiaofei Liu1, Diem Ngo1 1US FDA/OMPT/CDER/OPS/OTR/ Division of Pharmaceutical Analysis, Saint Louis, MO 2US FDA/OMPT/CDER/OC/OMPQ/DGMPA/NDMAB, Silver Spring, MD 3US FDA/OMPT/CDER/OND/ODEII/Division of Pulmonary, Allergy, and Rheumatology Products, Silver Spring, MD Received 20 December 2013; revised 18 July 2014; accepted 7 August 2014 Published online in Wiley Online […]
Shaw CJ, Kulkarni VS, Smith M, Farina DJ, Pitluk Z, Goth W. Using Quality by Design approach to correlate patient usage to the in vitro performance of a nasal spray product. Respiratory Drug Delivery. 2012. Contact the Respiratory Drug Delivery for further information.
Journal of Pharmaceutical Sciences, 99(4):2114-2122 (April 2010). Guo C1, Doub WH, Kauffman JF. Corresponding author: changning.guo@fda.hhs.gov 1Division of Pharmaceutical Analysis, U.S. Food and Drug Administration, 1114 Market Street, Room 1002, St. Louis, Missouri 63101 Abstract Design of experiment (DOE) methodology can provide a complete evaluation of the influences of nasal spray activation and formulation properties on delivery performance […]
Int J Pharm. 2010 Mar 30;388(1-2):82-7. doi: 10.1016/j.ijpharm.2009.12.041. Epub 2010 Jan 5. Liu X1, Doub WH, Guo C. U.S. Food & Drug Administration, Division of Pharmaceutical Analysis, 1114 Market Street, Room 1002, St. Louis, MO 63101, United States Abstract To determine aerosol deposition during the inhalation drug delivery, it is important to understand the combination of velocity […]
Farina DJ, LeBlanc SG. Investigation of the design space sensitivity for in vitro testing of commercially available nasal sprays using a statistical, Quality by Design approach. Inhaled and Nasal Technology Focus Group of the American Association of Pharmaceutical Sciences. 2009. Contact Inhaled and Nasal Technology Focus Group of the American Association of Pharmaceutical Scientists for […]
Journal of Pharmaceutical Sciences, 98(8):2799-2806 (August 2009). Guo C, Ye W, Kauffman JF, Doub WH. Corresponding author: changning.guo@fda.hhs.gov U.S. Food & Drug Administration, Division of Pharmaceutical Analysis, 1114 Market Street, Room 1002, St. Louis, Missouri 63101 Abstract The impaction force from an inhalation product is an important characteristics by which to characterize the spray plume. It is one of […]
European Journal of Pharmaceutical Sciences, 35(5):418-426 (September 2008). Guo Ca, Stine KJb, Kauffman JFa, Doub WHa. Corresponding author: changning.guo@fda.hhs.gov aDivision of Pharmaceutical Analysis, U.S. Food and Drug Administration, 1114 Market Street, Room 1002, St. Louis, MO 63101, United States bDepartment of Chemistry and Biochemistry and Center for Nanoscience, University of Missouri at St. Louis, 315 Benton Hall, One University […]
Journal of Pharmaceutical Sciences, 95(9):2029-2040 (September 2006). Guo C, Doub WH. Corresponding author: changning.guo@fda.hhs.gov Division of Pharmaceutical Analysis, U. S. Food and Drug Administration, 1114 Market Street, Room 1002, St. Louis, Missouri 63101 Abstract Nasal spray drug products are normally characterized via measurement of shot weight, spray pattern, plume geometry, and droplet size distribution (DSD). In this […]
Broome LM, Farina DJ, Vennari JA. Determination of nasal spray actuation parameters by exploratory studies of in vitro performance upon hand actuation using the Sprayview® NSx and Ergo NSP. Respiratory Drug Delivery. 2004. Contact the Respiratory Drug Delivery for further information.
