Thomas P Laughren

Summary

Affiliation: Food and Drug Administration
Country: USA

Publications

  1. doi request reprint What's next after 50 years of psychiatric drug development: an FDA perspective
    Thomas P Laughren
    Division of Psychiatry Products, Center for Drug Evaluation and Research, US Food and Drug Administration, 10903 New Hampshire Ave, Silver Spring, MD 20993, USA
    J Clin Psychiatry 71:1196-204. 2010
  2. ncbi request reprint A summary of the FDA-NIMH-MATRICS workshop on clinical trial design for neurocognitive drugs for schizophrenia
    Robert W Buchanan
    Maryland Psychiatric Research Center, P O Box 21247, Baltimore, MD 21228, USA
    Schizophr Bull 31:5-19. 2005
  3. doi request reprint Trial design issues and treatment effect modeling in multi-regional schizophrenia trials
    Yeh Fong Chen
    Division of Biometrics I, HFD 710, Food and Drug Administration, 10903 New HampshireAvenue, Building 21, Room 4610, Silver Spring, MD 20993 0002, USA
    Pharm Stat 9:217-29. 2010
  4. doi request reprint Vilazodone: clinical basis for the US Food and Drug Administration's approval of a new antidepressant
    Thomas P Laughren
    Division of Psychiatry Products, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave, Silver Spring, MD 20993, USA
    J Clin Psychiatry 72:1166-73. 2011
  5. pmc Wayne Fenton: impact on food and drug administration
    Thomas Laughren
    Schizophr Bull 33:1153. 2007
  6. doi request reprint FDA Perspective on the DSM-5 approach to classification of "cognitive" disorders
    Thomas Laughren
    Food and Drug Administration, Silver Spring, MD, USA
    J Neuropsychiatry Clin Neurosci 23:126-31. 2011
  7. doi request reprint Exploratory analyses of efficacy data from schizophrenia trials in support of new drug applications submitted to the US Food and Drug Administration
    Ni A Khin
    Division of Psychiatry Products, Office of Drug Evaluation I, Office of New Drugs, Food and Drug Administration, Silver Spring, MD, USA
    J Clin Psychiatry 73:856-64. 2012
  8. doi request reprint An integrated approach for establishing dosing recommendations: paliperidone for the treatment of adolescent schizophrenia
    Islam Rasem Younis
    Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD 20993, USA
    J Clin Psychopharmacol 33:152-6. 2013
  9. doi request reprint Exploratory analyses of efficacy data from major depressive disorder trials submitted to the US Food and Drug Administration in support of new drug applications
    Ni A Khin
    Division of Psychiatry Products, HFD 130, Food and Drug Administration, 10903 New Hampshire Ave, Bldg 22, Rm 4110, Silver Spring, MD 20993 0002, USA
    J Clin Psychiatry 72:464-72. 2011
  10. doi request reprint Development of a placebo effect model combined with a dropout model for bipolar disorder
    Wan Sun
    Division of Pharmacometrics, Office of Clinical Pharmacology, US Food and Drug Administration, 10903 New Hampshire Avenue, Silver Spring, MD 20993, USA
    J Pharmacokinet Pharmacodyn 40:359-68. 2013

Detail Information

Publications15

  1. doi request reprint What's next after 50 years of psychiatric drug development: an FDA perspective
    Thomas P Laughren
    Division of Psychiatry Products, Center for Drug Evaluation and Research, US Food and Drug Administration, 10903 New Hampshire Ave, Silver Spring, MD 20993, USA
    J Clin Psychiatry 71:1196-204. 2010
    ..In addition, a number of important safety initiatives, including Safety First, the Sentinel Initiative, the Safe Use Initiative, and meta-analysis for safety, are discussed...
  2. ncbi request reprint A summary of the FDA-NIMH-MATRICS workshop on clinical trial design for neurocognitive drugs for schizophrenia
    Robert W Buchanan
    Maryland Psychiatric Research Center, P O Box 21247, Baltimore, MD 21228, USA
    Schizophr Bull 31:5-19. 2005
    ....
  3. doi request reprint Trial design issues and treatment effect modeling in multi-regional schizophrenia trials
    Yeh Fong Chen
    Division of Biometrics I, HFD 710, Food and Drug Administration, 10903 New HampshireAvenue, Building 21, Room 4610, Silver Spring, MD 20993 0002, USA
    Pharm Stat 9:217-29. 2010
    ..When baseline body weight was considered as a covariate in an empiric model, our results indicated that it alone did not seem to be an important factor in explaining regional difference...
  4. doi request reprint Vilazodone: clinical basis for the US Food and Drug Administration's approval of a new antidepressant
    Thomas P Laughren
    Division of Psychiatry Products, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave, Silver Spring, MD 20993, USA
    J Clin Psychiatry 72:1166-73. 2011
    ....
  5. pmc Wayne Fenton: impact on food and drug administration
    Thomas Laughren
    Schizophr Bull 33:1153. 2007
  6. doi request reprint FDA Perspective on the DSM-5 approach to classification of "cognitive" disorders
    Thomas Laughren
    Food and Drug Administration, Silver Spring, MD, USA
    J Neuropsychiatry Clin Neurosci 23:126-31. 2011
    ..DSM-5 should include these associated features of each type of disorder, because acknowledging the full range of symptoms for each type of disorder has important research and treatment implications...
  7. doi request reprint Exploratory analyses of efficacy data from schizophrenia trials in support of new drug applications submitted to the US Food and Drug Administration
    Ni A Khin
    Division of Psychiatry Products, Office of Drug Evaluation I, Office of New Drugs, Food and Drug Administration, Silver Spring, MD, USA
    J Clin Psychiatry 73:856-64. 2012
    ....
  8. doi request reprint An integrated approach for establishing dosing recommendations: paliperidone for the treatment of adolescent schizophrenia
    Islam Rasem Younis
    Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD 20993, USA
    J Clin Psychopharmacol 33:152-6. 2013
    ....
  9. doi request reprint Exploratory analyses of efficacy data from major depressive disorder trials submitted to the US Food and Drug Administration in support of new drug applications
    Ni A Khin
    Division of Psychiatry Products, HFD 130, Food and Drug Administration, 10903 New Hampshire Ave, Bldg 22, Rm 4110, Silver Spring, MD 20993 0002, USA
    J Clin Psychiatry 72:464-72. 2011
    ..This report explores differences in efficacy data from placebo-controlled MDD trials submitted in support of new drug applications (NDAs) over a 25-year period...
  10. doi request reprint Development of a placebo effect model combined with a dropout model for bipolar disorder
    Wan Sun
    Division of Pharmacometrics, Office of Clinical Pharmacology, US Food and Drug Administration, 10903 New Hampshire Avenue, Silver Spring, MD 20993, USA
    J Pharmacokinet Pharmacodyn 40:359-68. 2013
    ..The joint placebo response and dropout models can serve as a tool to simulate the most likely level of placebo response with the expected dropout pattern to help design a new clinical trial...
  11. pmc Risk of suicidality in clinical trials of antidepressants in adults: analysis of proprietary data submitted to US Food and Drug Administration
    Marc Stone
    Center for Drug Evaluation and Research, US Food and Drug Administration, 10903 New Hampshire Avenue, Silver Spring, MD 20993 0002, USA
    BMJ 339:b2880. 2009
    ..To examine the risk of suicidal behaviour within clinical trials of antidepressants in adults...
  12. doi request reprint CYP2D6 genotype information to guide pimozide treatment in adult and pediatric patients: basis for the U.S. Food and Drug Administration's new dosing recommendations
    Hobart L Rogers
    Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, U S Food and Drug Administration, 10903 New Hampshire Ave, White Oak Bldg 51, Room 3175, Silver Spring, MD 20993, USA
    J Clin Psychiatry 73:1187-90. 2012
    ....
  13. pmc Assessment of community functioning in people with schizophrenia and other severe mental illnesses: a white paper based on an NIMH-sponsored workshop
    Alan S Bellack
    University of Maryland School of Medicine, 737 West Lombard Street, Suite 551, Baltimore, MD 21201, USA
    Schizophr Bull 33:805-22. 2007
    ..This criterion is problematic because different observers and constituencies often have different opinions about what types of change are clinically important and how much change is significant...
  14. pmc Food and Drug Administration perspective on negative symptoms in schizophrenia as a target for a drug treatment claim
    Thomas Laughren
    Food and Drug Administration, DNDP, HFD 120, 5600 Fishers Lane, Rockville, MD 20853, USA
    Schizophr Bull 32:220-2. 2006
    ....
  15. ncbi request reprint Conventional vs. atypical antipsychotic medications
    Marc Stone
    N Engl J Med 354:972-4; author reply 972-4. 2006