John J Orloff

Summary

Affiliation: Novartis Institutes for BioMedical Research

Publications

  1. doi The future of drug development: advancing clinical trial design
    John Orloff
    Novartis Pharmaceuticals Corporation, One Health Plaza, East Hanover, New Jersey 07936, USA
    Nat Rev Drug Discov 8:949-57. 2009
  2. doi Innovative approaches to clinical development and trial design
    John J Orloff
    Novartis Pharma AG, One Health Plaza, East Hanover, NJ 07936 1080, USA
    Ann Ist Super Sanita 47:8-13. 2011
  3. doi Communicating with the FDA: the "third rail" of a new model for drug development
    Donald R Stanski
    Global Head Modeling and Simulation, Novartis Pharmaceuticals Corporation, One Health Plaza, East Hanover, NJ 07936 1080, USA
    J Clin Pharmacol 48:144-5. 2008
  4. ncbi Cardiovascular safety of lumiracoxib: a meta-analysis of all randomized controlled trials > or =1 week and up to 1 year in duration of patients with osteoarthritis and rheumatoid arthritis
    Patrice Matchaba
    Novartis Pharmaceuticals Corporation, East Hanover, NJ 07936, USA
    Clin Ther 27:1196-214. 2005

Detail Information

Publications4

  1. doi The future of drug development: advancing clinical trial design
    John Orloff
    Novartis Pharmaceuticals Corporation, One Health Plaza, East Hanover, New Jersey 07936, USA
    Nat Rev Drug Discov 8:949-57. 2009
    ..Applications and examples of the use of these tools--such as Bayesian methodologies--in early- and late-stage drug development are discussed, as well as the advantages, challenges and barriers to their more widespread implementation...
  2. doi Innovative approaches to clinical development and trial design
    John J Orloff
    Novartis Pharma AG, One Health Plaza, East Hanover, NJ 07936 1080, USA
    Ann Ist Super Sanita 47:8-13. 2011
    ..Greater awareness of the distinct advantages of innovative designs by regulators and sponsors are crucial to increasing the adoption of these modern tools...
  3. doi Communicating with the FDA: the "third rail" of a new model for drug development
    Donald R Stanski
    Global Head Modeling and Simulation, Novartis Pharmaceuticals Corporation, One Health Plaza, East Hanover, NJ 07936 1080, USA
    J Clin Pharmacol 48:144-5. 2008
  4. ncbi Cardiovascular safety of lumiracoxib: a meta-analysis of all randomized controlled trials > or =1 week and up to 1 year in duration of patients with osteoarthritis and rheumatoid arthritis
    Patrice Matchaba
    Novartis Pharmaceuticals Corporation, East Hanover, NJ 07936, USA
    Clin Ther 27:1196-214. 2005
    ..The cardiovascular (CV) safety of non-steroidal anti-inflammatory drugs (NSAIDs) and selective cyclooxygenase-2 inhibitors has been the subject of considerable debate...