'Bridging studies' diaporamas de présentation

What Impact Will Globalization Have on Bridging Studies

What Impact Will Globalization Have on Bridging Studies. Katsuyoshi Shimatani J-Clin, Pfizer. Number of Consultation for Bridging Studies. Successful cases: >20. Kikoh Mr. Mori (07 October 2001). Drug Approved Through the Use of Overseas Data (1). (NCE). Year. Number of Approvals.

450 views • 25 slides

A Bayesian Non-Inferiority Approach to Evaluation of Bridging Studies Chin-Fu Hsiao, Jen-Pei Liu

A Bayesian Non-Inferiority Approach to Evaluation of Bridging Studies Chin-Fu Hsiao, Jen-Pei Liu Division of Biostatistics and Bioinformatics National Health Research Institites Huey-Miin Hsueh Department of Statistics National Cheng-Chi University

387 views • 17 slides

4 th Kitasato-Harvard Symposium: Summary and Conclusions

133 views • 13 slides

Wednesday October 2nd - Thursday October 3rd, 2002 New Ohtani Hotel, Tokyo

WORKSHOP 4: KEY COMMENTS FROM THE PANEL DISCUSSION The 3rd Kitasato University - Harvard School of Public Health Symposium. Wednesday October 2nd - Thursday October 3rd, 2002 New Ohtani Hotel, Tokyo. The 3rd Kitasato University - Harvard School of Public Health Symposium.

232 views • 12 slides

Implementation of the E5 Guideline: Status and Next Steps

Implementation of the E5 Guideline: Status and Next Steps. ICH and GCG. International leadership role in scientific harmonization Requirements for drug development must have a scientific basis Value of harmonization of regulations Brings innovative medicines to patients faster

232 views • 9 slides