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15 results
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Exercise-associated collapse in cyclists is unrelated to endotoxemia.
Moore GE, Holbein ME, Knochel JP. Moore GE, et al. Among authors: holbein me. Med Sci Sports Exerc. 1995 Sep;27(9):1238-42. Med Sci Sports Exerc. 1995. PMID: 8531621
Understanding FDA regulatory requirements for investigational new drug applications for sponsor-investigators.
Holbein ME. Holbein ME. J Investig Med. 2009 Aug;57(6):688-94. doi: 10.2310/JIM.0b013e3181afdb26. J Investig Med. 2009. PMID: 19602987 Free PMC article. Review.
Understanding Food and Drug Administration regulatory requirements for an investigational device exemption for sponsor-investigators.
Holbein ME, Berglund JP. Holbein ME, et al. J Investig Med. 2012 Oct;60(7):987-94. doi: 10.2310/JIM.0b013e318262df40. J Investig Med. 2012. PMID: 22847340 Free PMC article. Review.
Access to Investigational Drugs: FDA Expanded Access Programs or "Right-to-Try" Legislation?
Holbein ME, Berglund JP, Weatherwax K, Gerber DE, Adamo JE. Holbein ME, et al. Clin Transl Sci. 2015 Oct;8(5):526-32. doi: 10.1111/cts.12255. Epub 2015 Jan 15. Clin Transl Sci. 2015. PMID: 25588691 Free PMC article. Review.
Right now, in the right way: U. S. Food and Drug Administration's expanded access program and patient rights.
Holbein MEB, Weatherwax KJ, Gravelin M, Hutchinson R, Mashour GA. Holbein MEB, et al. J Clin Transl Sci. 2018 Jun;2(3):115-117. doi: 10.1017/cts.2018.318. J Clin Transl Sci. 2018. PMID: 30370061 Free PMC article. No abstract available.
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; Investigational New Drug/Investigational Device Exemption Task Force of the Clinical and Translational Science Award Consortium. Holbein ME, et al. J Investig Med. 2014 Jun;62(5):797-803. doi: 10.2310/JIM.0000000000000083. J Investig Med. 2014. PMID: 24831858 Free PMC article. Review.
Count me in: using a patient portal to minimize implicit bias in clinical research recruitment.
Kannan V, Wilkinson KE, Varghese M, Lynch-Medick S, Willett DL, Bosler TA, Chu L, Gates SI, Holbein MEB, Willett MM, Reimold SC, Toto RD. Kannan V, et al. Among authors: holbein meb. J Am Med Inform Assoc. 2019 Aug 1;26(8-9):703-713. doi: 10.1093/jamia/ocz038. J Am Med Inform Assoc. 2019. PMID: 31081898 Free PMC article.
Experience, Perceptions, and Recommendations Concerning COVID-19-Related Clinical Research Adjustments.
Gerber DE, Sheffield TY, Beg MS, Williams EL, Clark VL, Xie Y, Holbein MEB, Skinner CS, Lee SJC. Gerber DE, et al. Among authors: holbein meb. J Natl Compr Canc Netw. 2020 Oct 7:1-8. doi: 10.6004/jnccn.2020.7643. Online ahead of print. J Natl Compr Canc Netw. 2020. PMID: 33027755
Differential influence of arterial blood glucose on cerebral metabolism following severe traumatic brain injury.
Holbein M, B├ęchir M, Ludwig S, Sommerfeld J, Cottini SR, Keel M, Stocker R, Stover JF. Holbein M, et al. Crit Care. 2009;13(1):R13. doi: 10.1186/cc7711. Epub 2009 Feb 6. Crit Care. 2009. PMID: 19196488 Free PMC article.
Via media: Role and responsibilities of the independent safety officer.
Holbein MEB, Hammack BN, Melvin AJ, Knox TA. Holbein MEB, et al. J Clin Transl Sci. 2019 Aug 29;3(4):147-151. doi: 10.1017/cts.2019.393. eCollection 2019 Aug. J Clin Transl Sci. 2019. PMID: 31660239 Free PMC article.
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