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Publications


 

  • Holt, J., Sandell, D., Hickey, A., Vallorz III, E. and Straughn, K. (2015). ‘The Influence of Formulation Variables on a Beclomethasone Dipropionate Metered Dose Inhaler’, to appear at RDD Europe, May 5-8, 2015, Nice, France
  • Nichols, S., Sandell, D. and Mitchell, J. (2014). ‘Determination of Fine Particle Dose for Orally Inhaled Products (OIPs) by Abbreviated Impactor Methodologies: Results from a Multi-Centre Study’, DDL25, Dec 10-12, 2014, Edinburgh, UK
  • Holt, J., Hickey, A. and Sandell, D. (2014).From Q2 to QbD: The Influence of Formulation Changes on MDI Performance’, RDD Asia, Nov 12-14, 2014, Goa, India
  • Sandell, D. (2014). ‘Statistics of In-Vitro Equivalency’, Medicon Valley Inhalation Consortium (MVIC) symposium, Oct 15, 2014, Lund, Sweden
  • Sandell, D. (2014).‘Comparing NGI data for Two DPIs’, Sept 23-24 USP Roundtable on Statistical Approaches to Topics of Interest for Inhalation Products, Rockville, MD, USA
  • Sandell, D. (2014).‘A Designed Experiment to Compare the Fine Particle Dose Determined Using Abbreviated and Full Stage Impactor Instruments’, Sept 23-24 USP Roundtable on Statistical Approaches to Topics of Interest for Inhalation Products, Rockville, MD, USA
  • Sandell, D. (2014). ‘A rank-based test for population bioequivalence’, Sept 23-24 USP Roundtable on Statistical Approaches to Topics of Interest for Inhalation Products, Rockville, MD, USA
  • Sandell, D. and Mitchell, J. (2014). ‘Considerations for Designing In Vitro Bioequivalency (IVBE) Studies for pressurized Metered Dose Inhalers (pMDIs) with Spacer or Valved Holding Chamber (S/VHC) Add-on Devices’, Journal of Aerosol Medicine and Pulmonary Delivery Aug 2014
  • Sandell, D. (2014).A Real Case Comparison of Average and Population Bioequivalence for Evaluation of APSD data’, March 19, 2014 IPAC-RS/UF Orlando Inhalation Conference, Orlando, FL, USA
  • Sandell, D. (2013). ‘The Maths and Stats of Comparing Test and Reference, Nov 5-7 2013 Inhaled Drug Delivery. Management Forum London
  • Slator, L., von Hollen, D., Sandell, D. and Hatley, R. ‘In Vitro Comparison of the Effect of Inhalation delay and Flow Rate on the Emitted Dose from 4 Valved Holdiong Chambers’, Journal of Aerosol Medicine 2014 Aug;27 Suppl 1:S37-43
  • Hatley, R., von Hollen, D., Sandell, D. and Slator, L. ‘In Vitro Characterization of the OptiChamber Diamond Valved Holding Chamber’, Journal of Aerosol Medicine 2014 Aug;27 Suppl 1:S24-36
  • Burdick, R., LeBlond, D., Sandell, D., and Yang, H. (2013) ‘Statistical methods for Validation of Procedure Accuracy and Precision’, Pharmacopeial Forum 39(3)
  • Burdick, R., LeBlond, D., Sandell, D., and Yang, H. (2013) ‘Statistical methods for Validation of Procedure Accuracy and Precision’, Pharmacopeial Forum 39(3)
  • Capen, R., Christopher, D., Forenzo, P., Ireland, C., Liu, O., Lyapustina, S., O’Neill, J., Patterson, N., Quinlan, M., Sandell, D., Schwenke, J. Stroup, W. and Tougas, T. (2012) ‘On the Shelf Life of Pharmaceutical Products’, AAPS PharmSciTech 2012 Sep; 13(3):911-8.
  • Evans, C., Cipolla, D., Chesworth, T., Agurell, E., Ahrens, R., Conner, D., Dissanayake, S., Dolovich, M., Eng, P., Doub, W., Fuglsang, A., Arieta, A. G., Golden, M., Herrman, R., Hochhaus, G., Holmes, S., Lafferty, P., Lyapustina, S., Nair, P., O’Conner, D., Parkins, D., Peterson, I., Reisner, C., Sandell, D., Singh, G. J. P., Weda, M. and Watson, P. (2012) ‘Equivalence Considerations for Orally Inhaled Products for Local Action – ISAM/IPAC-RS European Workshop Report’ Journal of Aerosol Medicine 2012 Jun; 25(3):117-39
  • Sandell, D. (2012), ‘Planning of Experiments: Theoretical and Practical Considerations’ ISAM 2012 Aerosol School, Apr 11-13 2012 Hamilton, CA
  • Sandell, D. and Tougas, T. (2012), ‘Quality Considerations in the Establishment of Specifications for Pharmaceuticals’, Statistics in Biopharmaceutical Research Vol. 4(2), 125-35.
  • Sandell, D. (2011), ‘Some issues With the Current Method ’, USP Aerosol Workshop, Dec 12-13 2011 Washington, DC
  • Sandell, D. (2011). ‘US and EU Approaches to In-Vitro Equivalence’,
    Nov 7-9 2011 Inhaled Drug Delivery. Management Forum London
  • Tougas, T. and Sandell, D. (2011), ‘Defining and Ensuring the Quality of Pharmaceuticals’, Sep 12-13 2011 PQRI Workshop on Sample Sizes for Decision Making in New Manufacturing Paradigms in Bethesda.
  • Sandell, D., Tougas, T., O’Connor, D. and Horhota, S. (2011), ‘Quality Issues for Multi-Regional Clinical Trials’, Pharmaceutical Technology Oct 2011
  • Von Scuckmann, A-, Kamlag, Y., Mayer, S. & Sandell, D. (2010), ’Metering device for inhaling a powdery substance’, WO 2009/065707 A1
  • Von Scuckmann, A-, Kamlag, Y., Mayer, S. & Sandell, D. (2010), ’Dosing device for the inhalation of a powder substance’, WO 2009/065708 A2
  • Sandell, D. (2010), ‘Review of the EMEA Guidelines’ In-Vitro Equivalence Criteria for Cascade Impaction data’, ISAM/IPAC-RS EU Bioequivalence Workshop in Frankfurt.
  • Sandell, D. (2010), ‘Some Reflections on Shelf Life’, 2010 Joint Statistical Meeting in Vancouver.
  • Sandell, D. and Tougas, T.  (2009), ‘Quality Considerations in the Establishment of Specifications for Pharmaceuticals’, 2009 Non-Clinical Biostatistics Conference in Boston.
  • Tougas, T., Cahya, S., Christopher, D. and Sandell, D. (2008), ‘Estimating the Shelf Life of Pharmaceutical Products’, 2008 IPAC-RS conference.
  • Dennis, J., Berg, E., Sandell, D., Ali, A., Lamb, P., Tservistas, M., Karlsson, M. and Mitchell, J. (2008), ’Cooling the NGI – an approach to size a nebulised aerosol more accurately’, Pharmeuropa Scientific Notes 2008(1), 27-30
  • Foust, L., Diener, M., Gorko, M., Hofer, J., Larner, G., LeBlond, D., Lewis, J., Sandell, D., Schofield, T., Vukovinsky, K. and Warner, E. (2007), ‘Overcoming Disincentives to Process Understanding in the Pharmaceutical CMC Enviroment’, Pharmaceutical Technology September 2007
  • Dennis, J., Berg, E., Sandell, D., Ali, A., Lamb, P., Tservistas, M., Karlsson, M. and Mitchell, J. (2007), ’Investigation of the need to cool the Next generation Impactor (NGI) when sizing nebulized aerosol, ISAM Congress, Tours, France 2007
  • Sandell, D., Vukovinsky, K., Diener, M., Hofer, J., Pazdan, J. and Timmermans, J (2006), ‘Development of a content uniformity test suitable for large sample sizes’, Drug Information Journal 40(3).
  • Bagger-Jörgensen, H., Sandell, D., Lundbäck, H., and Sundahl, M. (2005), ‘Effect of inherent variability of inhalation products on impactor mass balance limits’, Journal of Aerosol Medicine 18, 367-378.
  • PhRMA Statistics and Stability Expert Teams (2005), ‘Identification of Out-Of-Trend Stability Results, Part II’, Pharmaceutical Technology October 2005, 62-68.
  • Lundbäck, Hans, Bagger-Jörgensen, Håkan, Sandell, D. and Sundahl, M. (2005), ‘Effect of inherent variability of inhalation products on impactor mass balance limits’, Respiratory Drug Delivery Europe 2005.
  • Sandell, D. (2005), ‘Specification setting for large N’, 28th Annual Midwest Biopharmaceutical Statistics Workshop.
  • DCU WG of IPAC-RS (2003), ‘Regarding Parametric Tolerance Interval (PTI) Test of Delivered Dose Uniformity (DDU) in Orally Inhaled and Nasal Drug Products’.
  • Sandell, D. (2003), ‘Different Methodologies to Identify Out of Trend’, FDA/PhRMA OUT-OF-TREND Stability Results Workshop.
  • PhRMA Statistics and Stability Expert Teams (2003), ‘Identification of Out-Of-Trend Stability Results’, Pharmaceutical Technology April 2003, 38 – 52.
  • Olsson, B. and Sandell, D. (2002), ‘Dose Content Uniformity Testing: IPAC-RS Advocacy and Justification’, Respiratory Drug Delivery 8.
  • DCU WG of IPAC-RS (2001), ‘A Parametric Tolerance Interval Test for Improved Control of Delivered Dose Uniformity of Orally Inhaled and Nasal Drug Products’.
  • Olsson, B. and Sandell, D. (2000), ‘Issues related to dose content uniformity testing of inhaled products’, Drug Delivery to the Lungs XI.
  • PSD WG of IPAC-RS (2000), ‘Initial Assessment of the ITFG/IPAC-RS Aerodynamic Particle Size Distribution Database’.
  • DCU WG of IPAC-RS (2000), ‘Initial Assessment of the ITFG/IPAC-RS Dose Content Uniformity Database’.
  • Blom, G., Englund J-E. and Sandell, D. (1998), ‘The Mississippi Problem’, The American Statistician 52, 1-2.
  • Sandell, D. (1997), ‘Fair Russian Roulette’, The Mathematical Scientist 22, 52-7.
  • Blom, G., Englund J-E. and Sandell, D. (1996), ‘General Russian Roulette’, Mathematics Magazine 69, 293-7.
  • Sandell, D. (1996), ‘Kronvägg’, Elementa 79, 67-71.
  • Blom, G., Holst, L. and Sandell, D. (1995), ‘Problems and Snapshots from the World of Probability’ (Japansee translation), Springer-Verlag, Tokyo.
  • Blom, G., Holst, L. and Sandell, D. (1995), ‘Three Sing-Sing problems’, The American Mathematical Monthly 103, 880-6.
  • Sandell, D. (1995), ‘Ett spel med tre spelare’, Normat 43, 113-9.
  • Blom, G. and Sandell, D. (1994), ‘Patterns in binary sequences’, The Mathematical Scientist 19, 88-97.
  • Blom, G., Holst, L. and Sandell, D. (1994), ‘Problems and Snapshots from the World of Probability’, Springer-Verlag, New York.
  • Blom, G. and Sandell, D. (1993), ‘Slumpvandring på kvadrat’, Normat 41, 156-60.
  • Blom, G. and Sandell, D. (1992), ‘Cover times for random walks on graphs’, The Mathematical Scientist 17, 111-9.
  • Sandell, D. (1992), ‘Hawthornes triangel’, Elementa 75, 76-80.
  • Sandell, D. (1991), ‘Computing probabilities in a generalized birthday problem’, The Mathematical Scientist 16, 78-82.
  • Sandell, D. (1990), ‘Estimation of Noise in Non-Linear Optical Processes – Application to CARS Thermometry’, Thesis, University of Lund.
  • Sandell, D. (1990), ‘Mer om födelsedagsproblemet’, Elementa 73, 26-8.
  • Sandell, D. (1989), ‘A game with three players’, Statistics and Probability Letters 7, 61-3.
  • Kröll, S. and Sandell, D. (1988), ‘Influence of laser mode statistics on noise in nonlinear optical processes – application to single-shot broadband coherent anti-Stokes Raman scattering thermometry’, Journal of the Optical Society of America B 5, 1910-26.
  • Kröll, S. and Sandell, D. (1987), ‘A model for calculating the noise due to the stochastic nature of multimode laser radiation in nonlinear optical processes’, in Proceedings of the International Conference on Nonlinear Optics (1987), 46-56, V. J. Corcoran ed., Society for Optics and Quantum Electronics.