Education
Undergraduate
University of Texas-Austin (1972), Pharmacy
Graduate School
University of Texas-Austin (1975), Pharmacology
Graduate School
Vanderbilt University (1981), Pharmacology

Publications

Featured Publications LegendFeatured Publications

Access to Investigational Drugs: FDA Expanded Access Programs or "Right-to-Try" Legislation?
Holbein ME, Berglund JP, Weatherwax K, Gerber DE, Adamo JE. Clin Transl Sci 2015 Epub ahead of print
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 ME, Berglund JP, O'Reilly EK, Hartman K, Speicher LA, Adamo JE, O'Riordan G, Brown JS, Schuff KG J. Investig. Med. 2014 Jun 62 5 797-803
Understanding food and drug administration regulatory requirements for an investigational device exemption for sponsor-investigators.
Holbein ME, Berglund JP J. Investig. Med. 2012 Oct 60 7 987-94
Understanding FDA regulatory requirements for investigational new drug applications for sponsor-investigators.
Holbein ME J. Investig. Med. 2009 Aug 57 6 688-94
Warning letters to sponsor-investigators at academic health centres - the regulatory "canaries in a coal mine"
O'Reilly EK, Blair Holbein ME, Berglund JP, Parrish AB, Roth MT, Burnett BK. Clin Invest Med 2013 36 6 E290-6
Exercise-associated collapse in cyclists is unrelated to endotoxemia.
Moore GE, Holbein ME, Knochel JP Med Sci Sports Exerc 1995 Sep 27 9 1238-42
Cost-effectiveness of monoclonal antibodies to gram-negative endotoxin in the treatment of gram-negative sepsis in ICU patients.
Chalfin DB, Holbein ME, Fein AM, Carlon GC JAMA 1993 Jan 269 2 249-54
Comparison of markers used in the assessment of glomerular filtration rate (GFR)
Holbein ME, Griener J, Knochel JP Am. J. Kidney Dis. 1991 Jun 17 6 724
Cephalosporin confusion--one simple solution?
Holbein ME, Crane VS Am J Hosp Pharm 1991 Feb 48 2 236
Intraventricular hemorrhage and vitamin E in the very low-birth-weight infant: evidence for efficacy of early intramuscular vitamin E administration.
Speer ME, Blifeld C, Rudolph AJ, Chadda P, Holbein ME, Hittner HM Pediatrics 1984 Dec 74 6 1107-12

Professional Associations/Affiliations
  • American Board of Clinical Pharmacology