C. Shaw, M. Smith, A. Richiuso, V. Kulkarni -DPT Laboratories Ltd. A. Newcomb – Proveris Scientific Corp. Annual Meeting of the American Association of Pharmaceutical Sciences. 2015; Poster R6087. Contact the American Association of Pharmaceutical Scientists for further information.
Alyssa Newcomb1, Dino J. Farina1, Ben Okorodudu1 1Proveris Scientific Corporation, 290 Donald Lynch Blvd, Suite 100, Marlborough, MA, U.S.A. Keywords Pressurized metered dose inhaler (“pMDI”), design of experiments (“DoE”), shaking duration, spray pattern, dose content uniformity (“DCU”), aerodynamic particle size distribution (“APSD”) Poster presentation at Inhalation Asia 2015. Contact Inhalation Asia for further information.
Authors: Polina L. Yarova1, Alecia L. Stewart2 *,Venkatachalem Sathish2 *,Rodney D. Britt Jr.2 *,Michael A. Thompson2 *,Alexander P. P. Lowe4 *, Michelle Freeman2, Bharathi Aravamudan2, Hirohito Kita3, Sarah C. Brennan1, Martin Schepelmann1, Thomas Davies1, Sun Yung1, Zakky Cholisoh4, Emma J. Kidd4, William R. Ford4, Kenneth J. Broadley4, Katja Rietdorf5, Wenhan Chang6, Mohd E. Bin Khayat7, Donald T. Ward7, Christopher J. Corrigan8, Jeremy P. T. Ward8, Paul J. Kemp1, Christina M. Pabelick2, Y. S. Prakash2 †, and Daniela Riccardi1 † 1School of Biosciences, Cardiff University, Cardiff […]
Bing V. Li and Ke Ren Presentation at the 2014 IPAC-RS Conference in Orlando, FL. Link is here. Outline: History of FDA guidance development on bioequivalence (BE) of nasal drug products Common issues observed in nasal product ANDA submissions FDA’s recommendations for improving application quality
AAPS Journal. July 2013, Volume 15, Issue 3, pp 875-883 Bing V. Li, Feiyan Jin, Sau L. Lee, Tao Bai, Badrul Chowdhury, Hoainhon T. Caramenico, Dale P. Conner Abstract: Demonstrating bioequivalence (BE) for nasal spray/aerosol products for local action has been very challenging because the relationship between the drug in systemic circulation and the drug […]
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 […]
Pitluk Z, Pallas S, Graaf J, Farina D. Comparison of impaction and non-impaction methods for measuring spray patterns for MDIs. Drug Delivery to the Lung. 2013. Contact Drug Delivery to the Lung, sponsored by the Aerosol Group, for further information.
Pharm Res. 2012 Nov;29(11):3122-30. doi: 10.1007/s11095-012-0804-7. Epub 2012 Jul 3. Doub WH1, Adams WP, Wokovich AM, Black JC, Shen M, Buhse LF. Corresponding author: email@example.com 1Division of Pharmaceutical Analysis, Food and Drug Administration CDER, OPS, St. Louis, Missouri, USA. ABSTRACT PURPOSE: To determine if cascade impactor (CI) measurement of drug in small particles from aqueous nasal sprays, described in FDA’s 2003 draft Nasal […]
Coowanitwong I, De S. Spray pattern and plume geometry analysis of a nasal peptide formulation in an Aptar Unit Dose Powder (UDP) device. Respiratory Drug Delivery. 2012. Contact the Respiratory Drug Delivery for further information.
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.