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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, Béchir 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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