Michael Krams

Summary

Affiliation: Wyeth Research
Country: USA

Publications

  1. ncbi Adaptive designs in clinical drug development: opportunities, challenges, and scope reflections following PhRMA's November 2006 workshop
    Michael Krams
    Wyeth Research, Collegeville, Pennsylvania 19426, USA
    J Biopharm Stat 17:957-64. 2007
  2. ncbi A bayesian dose-finding design adapting to efficacy and tolerability response
    S Krishna Padmanabhan
    Pfizer, Collegeville, Pennsylvania, USA
    J Biopharm Stat 22:276-93. 2012
  3. ncbi Missing steps in the STAIR case: a Translational Medicine perspective on the development of NXY-059 for treatment of acute ischemic stroke
    Giora Z Feuerstein
    Wyeth Research, Collegeville, Pennsylvania 19426, USA
    J Cereb Blood Flow Metab 28:217-9. 2008
  4. ncbi Adaptive designs in clinical drug development--an Executive Summary of the PhRMA Working Group
    Paul Gallo
    Novartis Pharmaceuticals, East Hanover, NJ 07936, USA
    J Biopharm Stat 16:275-83; discussion 285-91, 293-8, 311-2. 2006
  5. ncbi Innovative approaches for designing and analyzing adaptive dose-ranging trials
    Björn Bornkamp
    University of Dortmund, Dortmund, Germany
    J Biopharm Stat 17:965-95. 2007
  6. ncbi Acute Stroke Therapy by Inhibition of Neutrophils (ASTIN): an adaptive dose-response study of UK-279,276 in acute ischemic stroke
    Michael Krams
    Pfizer Global Research and Development, Sandwich, UK
    Stroke 34:2543-8. 2003
  7. ncbi The past is the future: innovative designs in acute stroke therapy trials
    Michael Krams
    Pfizer Global Research and Development, Groton, Conn, USA
    Stroke 36:1341-7. 2005
  8. ncbi Where the BOLD signal goes when alpha EEG leaves
    H Laufs
    Department of Neurology and Brain Imaging Center, Johann Wolfgang Goethe University, Frankfurt am Main, Germany
    Neuroimage 31:1408-18. 2006

Collaborators

Detail Information

Publications8

  1. ncbi Adaptive designs in clinical drug development: opportunities, challenges, and scope reflections following PhRMA's November 2006 workshop
    Michael Krams
    Wyeth Research, Collegeville, Pennsylvania 19426, USA
    J Biopharm Stat 17:957-64. 2007
    ..Rather than providing a comprehensive review of the presentations given, we limit ourselves to a selection of key statements. The authors reflect the position of PhRMA's working group on adaptive designs...
  2. ncbi A bayesian dose-finding design adapting to efficacy and tolerability response
    S Krishna Padmanabhan
    Pfizer, Collegeville, Pennsylvania, USA
    J Biopharm Stat 22:276-93. 2012
    ..We present various metrics from our simulation study, and conclude that this is an extremely efficient way of characterizing the risk-benefit profile of a drug during clinical development...
  3. ncbi Missing steps in the STAIR case: a Translational Medicine perspective on the development of NXY-059 for treatment of acute ischemic stroke
    Giora Z Feuerstein
    Wyeth Research, Collegeville, Pennsylvania 19426, USA
    J Cereb Blood Flow Metab 28:217-9. 2008
    ..Finally, rational patient selection and new outcome scales tailored in an adaptive design model must be evaluated...
  4. ncbi Adaptive designs in clinical drug development--an Executive Summary of the PhRMA Working Group
    Paul Gallo
    Novartis Pharmaceuticals, East Hanover, NJ 07936, USA
    J Biopharm Stat 16:275-83; discussion 285-91, 293-8, 311-2. 2006
    ..Three particular areas where it is felt that adaptive designs can be utilized beneficially are discussed: dose finding, seamless Phase II/III trials designs, and sample size reestimation...
  5. ncbi Innovative approaches for designing and analyzing adaptive dose-ranging trials
    Björn Bornkamp
    University of Dortmund, Dortmund, Germany
    J Biopharm Stat 17:965-95. 2007
    ....
  6. ncbi Acute Stroke Therapy by Inhibition of Neutrophils (ASTIN): an adaptive dose-response study of UK-279,276 in acute ischemic stroke
    Michael Krams
    Pfizer Global Research and Development, Sandwich, UK
    Stroke 34:2543-8. 2003
    ..The prime objective was to determine the dose that gave a clinically relevant effect in patients...
  7. ncbi The past is the future: innovative designs in acute stroke therapy trials
    Michael Krams
    Pfizer Global Research and Development, Groton, Conn, USA
    Stroke 36:1341-7. 2005
  8. ncbi Where the BOLD signal goes when alpha EEG leaves
    H Laufs
    Department of Neurology and Brain Imaging Center, Johann Wolfgang Goethe University, Frankfurt am Main, Germany
    Neuroimage 31:1408-18. 2006
    ..Finally, we relate these findings to the concepts of 'resting state' and 'default mode' and discuss how - as for sleep - EEG-based criteria might be used for staging brain activity during wakefulness...