David Goldsmith MD

PubMed

• 54 citations
  Influence of the MedDRA hierarchy on pharmacovigilance data mining results.
  Ronald K. Pearson, Manfred Hauben, David I. Goldsmith, A. Lawrence Gould, David Madigan
  International Journal of Medical Informatics. 2009-12-01
• 32 citations
  Systematic Review of the Evidence Underlying the Association Between Mineral Metabolism Disturbances and Risk of Fracture and Need for Parathyroidectomy in CKD
  David Goldsmith, Prajesh Kothawala, Arpi Chalian, Myriam Bernal, Sean Robbins
  American Journal of Kidney Diseases. 2009-06-01
• 35 citations
  An evaluation of three signal-detection algorithms using a highly inclusive reference event database.
  Alan M. Hochberg, Manfred Hauben, Ronald K. Pearson, Donald J. O’Hara, Stephanie J. Reisinger
  Drug Safety. 2009-01-01

Journal Articles

• Influence of the MedDRA hierarchy on pharmacovigilance data mining results  
  Pearson Ronald K; Hauben Manfred; Goldsmith David I; Gould A Lawrence; Madigan David; O'Hara Donald J; Reisinger Stephanie J; Hochberg Alan M, International Journal of Medical Informatics, 1/1/2009
• An Evaluation of Three Signal-Detection Algorithms Using a Highly Inclusive Reference Event Database  
  Hochberg AM, Hauben M, Pearson RK, O'Hara DJ, Reisinger SJ, Goldsmith DI, Gould AL, and Madigan D, Drug Safety, 1/1/2009
• The authors' reply  
  Kelly W, Moore N, Goldsmith DI, Jones JK, Trenque T, and van Puijenbroek E, Drug Safety, 1/1/2008
• Guidelines for Submitting Adverse Event Reports for Publication  
  Kelly, W.N., Arellano, F M., Barnes, J. Bergman, U. Edwards, R.I., Fernandez, A.M., Freedman, S.B., Goldsmith, D.I., Huang, K.A., Jones, J.K. McLeay, R. Moore, N., Sta..., Pharmacoepidemiology and Drug Safety, 1/1/2007
• Guidelines for Submitting Adverse Event Reports for Publication  
  Kelly, W.N., Arellano, F M., Barnes, J. Bergman, U. Edwards, R.I., Fernandez, A.M., Freedman, S.B., Goldsmith, D.I., Huang, K.A., Jones, J.K. McLeay, R. Moore, N., Sta..., Drug Safety, 1/1/2007
• What Counts in Data Mining?  
  Hauben, M., Patadia V.K., Goldsmith, D., Drug Safety, 1/1/2006
• Accelerating statistical research in drug safety  
  Bilker, W., Gogolak, V., Goldsmith, D., Hauben M., Herrera, G., Hochberg, A., Jolley, S., Kulldorff, M., Madigan D., Nelson, R., Shapiro A., Shmueli, G., Pharmacoepidemiology and Drug Safety, 1/1/2006
• Should serious adverse events requiring expedited regulatory reporting be unblinded?  
  Gait, J.E. and Goldsmith, D.I., Int. J. Pharm Med., 1/1/2000
• The impact of the International Conference on Harmonization (ICH) on Pharmacoepidemiology and Pharmacovigilance  
  Goldsmith, D.I., Pharmacoepidemiology and Drug Safety, 1/1/1998
• Glomerular capillary permeability in developing canines  
  Goldsmith, D.I, Jodorkovsky R. A., Sherwinter, J., Kleeman S. R. and Spitzer A., Am J Physiol Renal Physiol, 1/1/1986
• A comprehensive system for international pharmaceutical company monitoring of adverse drug reactions  
  Goldsmith, D.I., Yen, C.C. and Greenberg, B.P., Drug Information J., 1/1/1986
• The effect of captopril on urinary protein excretion in puromycin aminonucleoside nephrosis in rats  
  Trachtman, H., Zavilowitz, B., Bennett, B., Goldsmith, D.I., Pediatr Res, 1/1/1985
• Identification of osmotically active solutes in urine  
  Goldsmith, D.I., Martinez, A.B., and Schwartz, G.J., Crit. Care Med., 1/1/1985
• Minimal change nephrotic syndrome in children: deaths during the first five to fifteen year's observation A report of the International Study of Kidney Diseases in Chi...  
  Goldsmith, D.I., et al, Pediatrics, 1/1/1984
• Ileal segment replacement of ureter: effects on kidney of refluxing vs Nonrefluxing ileovesical anastomosis  
  Vatandaslar, V., Reid, R.E., Freed, S.Z., Smey, P., Kogan, S.J., Goldsmith, D.I., Bernstein, R., and Levitt, S.B., Urology, 1/1/1984
• Dynamic characteristics of a refluxing, non-refluxing and totally tapered "ileal ureter"  
  Vatandaslar, V., Reid, R.E., Freed, S.Z., Smey, P., Kogan, S.J., Goldsmith, D.I., Bernstein, R., and Levitt, S.B., Urology, 1/1/1984
• The impact of age on the effects of ureteral obstruction on renal function  
  Taki., M., Goldsmith, D.I., and Spitzer, A., Kidney Int., 1/1/1983
• Early identification of frequent relapsers among children with minimal change nephrotic syndrome A report of the International Study of Kidney Diseases in Children  
  Goldsmith, D.I., et al, J. Pediatr., 1/1/1982
• The relationship between intravascular volume expansion and natriuresis in developing puppies  
  Aladjem M., Spitzer A., and Goldmsith, D.I., Pediatric Res., 1/1/1982
• Dialogues in Pediatric Urology  
  Goldsmith, D.I., 1/1/1981
• The primary nephrotic syndrome in children: Clinical significance of histopathologic variants of minimal change and of diffuse mesangial hypercellularity A report of t...  
  Goldsmith, D.I., et al, Kidney Int., 1/1/1981
• Quantitative changes in the canine glomerular vasculature during development: physiologic implications  
  John, E., Goldsmith, D.I., and Spitzer A, Kidney Int., 1/1/1981
• The primary nephrotic syndrome in children Identification of patients with minimal change nephrotic syndrome from initial response to prednisone A report of the Intern...  
  Goldsmith, D.I., et al, J. Pediatr., 1/1/1981
• Lead intoxication during development: its late effects on kidney function and blood pressure  
  Aviv A., John E., Bernstein, J., Goldsmith, D.I., and Spitzer A., Kidney Int., 1/1/1980
• The renin angiotensin system in newborn dogs  
  Drukker, A., Goldsmith, D.I., Spitzer, A., Edelman, C.M., Jr., and Blaufox, M.D., Pediatric Res., 1/1/1980
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Books/Book Chapters

• Proceedings of the Fifth International Conference on Harmonisation, San Diego 2000 
  Chapter: Data Safety Monitoring: E2B Maintenance: An Update: Progress Overview. 
  Goldsmith, D.I.Editors: Margaret C. Cone.PJB Publications Ltd, Richmond, UK2001
• Pediatric Primary Care: A Symptomatic Approach 
  Chapter: The abnormal urine and urinary tract. 
  Goldsmith, D.I.Editors: S.P. Sheloff, A.P. Mezey, C.M. Edelmann Jr., and H.L. Barnett.Appleton, Century, and Crofts, Norwalk1984
• The Kidney During Development 
  Chapter: Mechanisms for early postnatal changes in the natriuretic response to volume expansion. 
  Aladjem, M. and Goldsmith, D.I.Editors: A. Spitzer.Masson Publishing USA, Inc., NY1982
• Pediatric Kidney Disease 
  Chapter: Clinical and laboratory evaluation of renal function. 
  Goldsmith, D.I.Editors: C.M. Edelman, Jr..Little, Brown and Company, Boston1978
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Abstracts/Posters

• Signal Confirmation Using a Case Control Study of Spontaneous Report.
  Hauben, M., Goldsmith, D.I., Moreau, C., Shapiro, E., X International Conference on Pharmacoepidemiology, Montreal, 1/1/1995
• Sensitivity of Spontaneous Reporting to Non-Pharmacologic Stimuli: A case study.
  Hauben, M., Suljaga-Petchel, Goldsmith, D.I., and Reich, L., Post Marketing Surveillance, VIII International Congress on Pharmacoepidemiology, Minneapolis, MN, 1/1/1992
• Misapplication of Ionic Contrast Media: Confirmation of Hypothesis Through Spontaneous Reporting System.
  Reich, L., Hauben, M., Suljaga-Petchel, K., Shapiro, E., Cortina, L. Bohn H., and Goldsmith, D.I., Post Marketing Surveillance, VIII International Congress on Pharmacoepidemiology, Minneapolis, MN, 1/1/1992
• Model Safety Report Based on FOI Data.
  Suljaga-Petchel, K., Houlihan K., and Goldsmith, D.I., VII International Congress on Pharmacoepidemiology, Basel, 1/1/1991
• The Peer Review Process for Oral Presentations at the 6th International Congress on Pharmacoepidemiology.
  Goldsmith, D.I., VII International Congress on Pharmacoepidemiology, Basel, 1/1/1991
• Labelling Consistency in a Multinational Corporation.
  Goldsmith, D.I., Rumore, M.M., Drug Information Association, New Orleans, LA, 1/1/1989
• The Management of Adverse Experience Information Phase I Through Epidemiology.
  Goldsmith, D.I., Drug Information Association Annual Meeting, New Orleans, LA, 1/1/1989
• A comprehensive system for international pharmaceutical company monitoring of adverse drug reactions.
  Goldsmith, D.I., Yen, C.C. and Greenberg, B.P., Information Association, Rome, Italy, 1/1/1985
• The effect of angiotensin II on glomerular vasculature.
  Goldsmith, D.I., Lu, Y.X., Pomerantz, A.S., and Spitzer, A., Pediatric Res, Society for Pediatric Research, 1/1/1985
• The role of aldosterone in renal electrolyte transport during development.
  Ito, Y., Goldsmith, D.I., and Spitzer, A., Pediatric Research, Society for Pediatric Research, 1/1/1984
• The relationship between plasma aldosterone concentration and renal electrolyte transport during development.
  Ito, Y., Goldsmith, D.I., Zavilowitz, B., and Spitzer, A., Sixth International Pediatric Symposium, 1/1/1983
• Captopril attenuation of puromycin aminonucleoside induced proteinuria in rats.
  Trachtman, H., Zavilowitz, B., and Goldsmith, D.I., Pediatric Res, Society for Pediatric Research, 1/1/1983
• Cyclophosphamide therapy in focal segmental glomerular sclerosis: a controlled clinical trial. A report of the International Study of Kidney Disease in Children.
  Goldsmith, D.I., Pediatric Res, Combined Plenary Session of the Society for Pediatric Research and the American Pediatric Society, 1/1/1982
• Alternate day steroid therapy in memranoproliferative glomerulonephritis: a controlled clinical trial. A report of the International Study of Kidney Disease in Children.
  Goldsmith, D.I., Kidney Int., The American Society of Nephrology, 1/1/1982
• The primary nephrotic syndrome in children: clinical significance of histopathology variants of minimal change and of diffuse mesangial hypercellularity. A report of t...
  Bernstein, J., Kidney Int., The American Society of Nephrology, 1/1/1982
• Dynamic characteristics of a refluxing, non-refluxing and totally tapered ileal ureter.
  Vatandaslar, V., Reid, R.E., Freed, S.Z., Smey, P., Kogan, S.J., Goldsmith, D.I., and Levitt, S.B., The American Urological Association, 1/1/1982
• International Collaborative Study for Kidney Disease in Children-a progress report.
  Goldsmith, D.I., The Fifth International Pediatric Nephrology Symposium, Philadelphia, 1/1/1981
• Mechanisms for early postnatal changes in the natriuretic response to volume expansion.
  Goldsmith, D.I., First International Workshop on Developmental Renal Physiology, New York, 1/1/1981
• Glomerular permselectivity during development.
  Goldsmith, D.I., Jodorkovsky, R.A., and Spitzer, A., Pediatric Res, Society of for Pediatric Research, 1/1/1981
• The effect of chronic partial ureteral obstruction (CPUO) on kidney growth and function during maturation.
  Taki, M., Goldsmith, D.I., and Spitzer, A., Pediatric Res, Society of for Pediatric Research, 1/1/1980
• The effect of chronic partial ureteral (CPUO) on renal tubular transport during maturation.
  Taki, M., Goldsmith, D.I., and Spitzer, A., Pediatric Res, 1/1/1980
• Age related differences in natriuretic response independent of changes in intravascular volume.
  Goldsmith, D.I., Aladjem, M., and Spitzer, A., Pediatric Res, Society of for Pediatric Research, 1/1/1979
• Changes in glomerular capillary permeability to dextrans during development.
  Goldsmith, D.I., Jodorkovsky, R.A., Kleeman, S.R., Sherwinter, J. and Spitzer, A., Pediatric Res, Society of for Pediatric Research, 1/1/1979
• Plasma creatinine concentration: Determination, normal values and use for estimating GFR.
  Schwartz, G.J., Haycock, G.B. Edelmann, C.M. Jr., Goldsmith, D.I., and Spitzer, A., IV International Symposium of Pediatric Nephrology, Helsinki, 1/1/1977
• Role of the kidney in sodium homeostasis during development.
  Spitzer, A., Schoeneman, M., and Goldsmith, D.I., IV International Symposium of Pediatric Nephrology, Helsinki, 1/1/1977
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Lectures

• Science of Biosimilars 
  1/1/2015
• Blind or Unblind Maintain the blind point of view. 
  1/1/2013
• MedDRA and Datamining 
  1/1/2010
• The Place of Signals of Disproportionate Reporting in Risk Management 
  1/1/2007
• Tutorial on Signal Detection, Case Assessment and Data Mining in Pharmacovigilance: Current State of the Art 
  1/1/2006
• The MedDRA Hierarchy and Data Mining 
  1/1/2006
• Data Mining in Pharmacovigilance: Help or Hype? 
  1/1/2006
• Unblinding: What Are Decision Trees for? 
  1/1/2005
• Data Mining Nuggets or Fools Gold? 
  1/1/2004
• The tome, new proposed rules by the FDA 
  1/1/2004
• MedDRA search strategies for Risk Management. 
  1/1/2003
• FDA initiatives on Risk Management 
  1/1/2003
• Data Safety Monitoring: E2B Maintenance: An Update 
  1/1/2000
• "Postmarketing Surveillance: Considerations for Policymakers" 
  1/1/1999
• Electronic Adverse Event Report Using MedDRA and Electronic Standards 
  1/1/1998
• Overview: What's the Same, What's Different-The Nuts and Bolts. 
  Key Bridge Marriott, Arlington, VA - 1/1/1998
• Introduction of Workshop: An Overview or Major Changes-From Old to New 
  Key Bridge Marriott, Arlington, VA - 1/1/1998
• The Integration of Database from Old to New. 
  The Airport Marriott, Philadelphia, PA - 1/1/1998
• The U.S. Industry Perspective; User Guidance to Electonic Transmission of Individual Case Report 
  Hynes Convention Center, Boston, MA - 1/1/1998
• The Use of Meddra and Electronic Data Submission to Regulators. 
  The Westin Hotel, Washington, DC - 1/1/1998
• Nuts and Bolts of Expedited and Periodic Reporting. 
  Key Bridge Marriott, Arlington, VA - 1/1/1998
• ICH E2B-Data Elements for Electronic Submission of Adverse Events. 
  Center for Professional Advancement, Burlingame, CA - 1/1/1998
• ICH and Electronic Submission of Adverse Drug Reaction Reports. 
  Watergate Hotel, Washington, DC - 1/1/1997
• "Postmarketing Drug Safety Monitoring-From Spontaneous ADE Reports to Pharmacoepidemiologic Studies Training Course." 
  1/1/1997
• Data Encoding & Data Retrieval 
  New Brunswick, NJ - 1/1/1997
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