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Data Rich, Information Poor: Can We Use Electronic Health Records to Create a Learning Healthcare System for Pharmaceuticals?
Eichler HG, Bloechl-Daum B, Broich K, Kyrle PA, Oderkirk J, Rasi G, Santos Ivo R, Schuurman A, Senderovitz T, Slawomirski L, Wenzl M, Paris V. Eichler HG, et al. Among authors: bloechl daum b. Clin Pharmacol Ther. 2019 Apr;105(4):912-922. doi: 10.1002/cpt.1226. Epub 2018 Oct 14. Clin Pharmacol Ther. 2019. PMID: 30178490 Free PMC article.
From adaptive licensing to adaptive pathways: delivering a flexible life-span approach to bring new drugs to patients.
Eichler HG, Baird LG, Barker R, Bloechl-Daum B, Børlum-Kristensen F, Brown J, Chua R, Del Signore S, Dugan U, Ferguson J, Garner S, Goettsch W, Haigh J, Honig P, Hoos A, Huckle P, Kondo T, Le Cam Y, Leufkens H, Lim R, Longson C, Lumpkin M, Maraganore J, O'Rourke B, Oye K, Pezalla E, Pignatti F, Raine J, Rasi G, Salmonson T, Samaha D, Schneeweiss S, Siviero PD, Skinner M, Teagarden JR, Tominaga T, Trusheim MR, Tunis S, Unger TF, Vamvakas S, Hirsch G. Eichler HG, et al. Among authors: bloechl daum b. Clin Pharmacol Ther. 2015 Mar;97(3):234-46. doi: 10.1002/cpt.59. Epub 2015 Feb 4. Clin Pharmacol Ther. 2015. PMID: 25669457 Free PMC article.
The risks of risk aversion in drug regulation.
Eichler HG, Bloechl-Daum B, Brasseur D, Breckenridge A, Leufkens H, Raine J, Salmonson T, Schneider CK, Rasi G. Eichler HG, et al. Among authors: bloechl daum b. Nat Rev Drug Discov. 2013 Dec;12(12):907-16. doi: 10.1038/nrd4129. Epub 2013 Nov 15. Nat Rev Drug Discov. 2013. PMID: 24232377 Review.
"Threshold-crossing": A Useful Way to Establish the Counterfactual in Clinical Trials?
Eichler HG, Bloechl-Daum B, Bauer P, Bretz F, Brown J, Hampson LV, Honig P, Krams M, Leufkens H, Lim R, Lumpkin MM, Murphy MJ, Pignatti F, Posch M, Schneeweiss S, Trusheim M, Koenig F. Eichler HG, et al. Among authors: bloechl daum b. Clin Pharmacol Ther. 2016 Dec;100(6):699-712. doi: 10.1002/cpt.515. Epub 2016 Oct 19. Clin Pharmacol Ther. 2016. PMID: 27650716 Free PMC article.
Low risk pragmatic trials do not always require participants' informed consent.
Dal-Ré R, Avendaño-Solà C, Bloechl-Daum B, de Boer A, Eriksson S, Fuhr U, Holm S, James SK, Mentz RJ, Perucca E, Rosendaal FR, Treweek S. Dal-Ré R, et al. Among authors: bloechl daum b. BMJ. 2019 Mar 27;364:l1092. doi: 10.1136/bmj.l1092. BMJ. 2019. PMID: 30917969 No abstract available.
European regulation on orphan medicinal products: 10 years of experience and future perspectives.
Committee for Orphan Medicinal Products and the European Medicines; Westermark K, Holm BB, Söderholm M, Llinares-Garcia J, Rivière F, Aarum S, Butlen-Ducuing F, Tsigkos S, Wilk-Kachlicka A, N'Diamoi C, Borvendég J, Lyons D, Sepodes B, Bloechl-Daum B, Lhoir A, Todorova M, Kkolos I, Kubáčková K, Bosch-Traberg H, Tillmann V, Saano V, Héron E, Elbers R, Siouti M, Eggenhofer J, Salmon P, Clementi M, Krieviņš D, Matulevičiene A, Metz H, Vincenti AC, Voordouw A, Dembowska-Bagińska B, Nunes AC, Saleh FM, Foltánová T, Možina M, Torrent i Farnell J, Beerman B, Mariz S, Evers MP, Greene L, Thorsteinsson S, Gramstad L, Mavris M, Bignami F, Lorence A, Belorgey C. Committee for Orphan Medicinal Products and the European Medicines, et al. Among authors: bloechl daum b. Nat Rev Drug Discov. 2011 May;10(5):341-9. doi: 10.1038/nrd3445. Nat Rev Drug Discov. 2011. PMID: 21532564 Review.