Clinical Sciences - IRB Prereview

Fingerprint The fingerprint is based on mining the text of the scientific documents related to the associated persons. Based on that an index of weighted terms is created, which defines the key subjects of research unit

Investigational Drugs Chemical Compounds
United States Food and Drug Administration Medicine & Life Sciences
Research Personnel Medicine & Life Sciences
Endotoxins Medicine & Life Sciences
Cost-Benefit Analysis Medicine & Life Sciences
Intensive Care Units Medicine & Life Sciences
Investigational New Drug Application Medicine & Life Sciences
Sepsis Medicine & Life Sciences

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Profiles

No photo of M E Blair Holbein
19832015

Research Output 1991 2015

7 Citations

Access to Investigational Drugs: FDA Expanded Access Programs or "Right-to-Try" Legislation?

Holbein, M. E. B., Berglund, J. P., Weatherwax, K., Gerber, D. E. & Adamo, J. E. Oct 1 2015 In : Clinical and Translational Science. 8, 5, p. 526-532 7 p.

Research output: Contribution to journalArticle

Investigational Drugs
Legislation
Biological Factors
Pharmaceutical Preparations
Research Ethics Committees
1 Citations

Recommendations from the Investigational New Drug/Investigational Device Exemption Task Force of the Clinical and Translational Science Award consortium: Developing and implementing a sponsor-investigators training program

Holbein, M. E. B., Berglund, J. P., O'Reilly, E. K., Hartman, K., Speicher, L. A., Adamo, J. E., O'Riordan, G., Brown, J. S. & Schuff, K. G. 2014 In : Journal of Investigative Medicine. 62, 5, p. 797-803 7 p.

Research output: Contribution to journalArticle

Investigational Drugs
Advisory Committees
Research Personnel
Education
Equipment and Supplies

Warning letters to sponsor- investigators at academic health centres - the regulatory "canaries in a coal mine"

O'Reilly, E. K., Holbein, M. E. B., Berglund, J. P., Parrish, A. B., Roth, M. T. & Burnett, B. K. 2013 In : Clinical and Investigative Medicine. 36, 6

Research output: Contribution to journalArticle

Canaries
Coal
United States Food and Drug Administration
Research Personnel
Health