Patrick Y Muller

Summary

Affiliation: Novartis Institutes for BioMedical Research

Publications

  1. ncbi The determination and interpretation of the therapeutic index in drug development
    Patrick Y Muller
    Novartis Institutes for BioMedical Research, 250 Massachusetts Avenue, Cambridge, Massachusetts 02139, USA
    Nat Rev Drug Discov 11:751-61. 2012
  2. ncbi Safety assessment and dose selection for first-in-human clinical trials with immunomodulatory monoclonal antibodies
    P Y Muller
    Novartis Institutes for BioMedical Research, Basel, Switzerland
    Clin Pharmacol Ther 85:247-58. 2009
  3. ncbi Tissue-specific, non-invasive toxicity biomarkers: translation from preclinical safety assessment to clinical safety monitoring
    Patrick Y Muller
    Novartis Institutes for BioMedical Research, Basel, Switzerland
    Expert Opin Drug Metab Toxicol 5:1023-38. 2009
  4. ncbi The minimum anticipated biological effect level (MABEL) for selection of first human dose in clinical trials with monoclonal antibodies
    Patrick Y Muller
    Novartis Institutes for BioMedical Research, Basel, Switzerland
    Curr Opin Biotechnol 20:722-9. 2009
  5. ncbi Comparative requirements for exploratory clinical trials -- eIND, eCTA and microdosing
    Patrick Y Muller
    Novartis Institutes for BioMedical Research, Cambridge, MA 02139, USA
    Adv Drug Deliv Rev 63:511-7. 2011
  6. ncbi Safety and immunotoxicity assessment of immunomodulatory monoclonal antibodies
    Frank R Brennan
    Novartis Biologicals, Translational Sciences and Safety, Basel, Switzerland
    MAbs 2:233-55. 2010

Detail Information

Publications6

  1. ncbi The determination and interpretation of the therapeutic index in drug development
    Patrick Y Muller
    Novartis Institutes for BioMedical Research, 250 Massachusetts Avenue, Cambridge, Massachusetts 02139, USA
    Nat Rev Drug Discov 11:751-61. 2012
    ..This article critically discusses the various aspects of TI determination and interpretation in drug development for both small molecule drugs and biotherapeutics...
  2. ncbi Safety assessment and dose selection for first-in-human clinical trials with immunomodulatory monoclonal antibodies
    P Y Muller
    Novartis Institutes for BioMedical Research, Basel, Switzerland
    Clin Pharmacol Ther 85:247-58. 2009
    ..In addition, the current regulatory requirements are presented and discussed to demonstrate how the TeGenero TGN1412 case is leading to increased regulatory scrutiny regarding dose selection for FIH clinical trials...
  3. ncbi Tissue-specific, non-invasive toxicity biomarkers: translation from preclinical safety assessment to clinical safety monitoring
    Patrick Y Muller
    Novartis Institutes for BioMedical Research, Basel, Switzerland
    Expert Opin Drug Metab Toxicol 5:1023-38. 2009
    ..In addition, the current regulatory status is presented and discussed in view of recent changes in regulatory acceptance by health authorities...
  4. ncbi The minimum anticipated biological effect level (MABEL) for selection of first human dose in clinical trials with monoclonal antibodies
    Patrick Y Muller
    Novartis Institutes for BioMedical Research, Basel, Switzerland
    Curr Opin Biotechnol 20:722-9. 2009
    ..In this review, strategies for estimation of the MABEL for mAbs specific for both membrane and soluble targets are presented and the scientific and regulatory challenges highlighted...
  5. ncbi Comparative requirements for exploratory clinical trials -- eIND, eCTA and microdosing
    Patrick Y Muller
    Novartis Institutes for BioMedical Research, Cambridge, MA 02139, USA
    Adv Drug Deliv Rev 63:511-7. 2011
    ....
  6. ncbi Safety and immunotoxicity assessment of immunomodulatory monoclonal antibodies
    Frank R Brennan
    Novartis Biologicals, Translational Sciences and Safety, Basel, Switzerland
    MAbs 2:233-55. 2010
    ..Finally, the use of immunopharmacology and immunotoxicity data in determining a minimum anticipated biologic effect Level (MABEL) and in the selection of safe human starting dose is discussed...