John J Orloff
Affiliation: Novartis Institutes for BioMedical Research
- The future of drug development: advancing clinical trial designJohn 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...
- Innovative approaches to clinical development and trial designJohn 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...
- Communicating with the FDA: the "third rail" of a new model for drug developmentDonald 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
- 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 arthritisPatrice 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...