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Real World Data in Adaptive Biomedical Innovation: A Framework for Generating Evidence Fit for Decision-Making.
Schneeweiss S, Eichler HG, Garcia-Altes A, Chinn C, Eggimann AV, Garner S, Goettsch W, Lim R, Löbker W, Martin D, Müller T, Park BJ, Platt R, Priddy S, Ruhl M, Spooner A, Vannieuwenhuyse B, Willke RJ. Schneeweiss S, et al. Among authors: eichler hg. Clin Pharmacol Ther. 2016 Dec;100(6):633-646. doi: 10.1002/cpt.512. Epub 2016 Oct 19. Clin Pharmacol Ther. 2016. PMID: 27627027
Adaptive licensing: taking the next step in the evolution of drug approval.
Eichler HG, Oye K, Baird LG, Abadie E, Brown J, Drum CL, Ferguson J, Garner S, Honig P, Hukkelhoven M, Lim JC, Lim R, Lumpkin MM, Neil G, O'Rourke B, Pezalla E, Shoda D, Seyfert-Margolis V, Sigal EV, Sobotka J, Tan D, Unger TF, Hirsch G. Eichler HG, et al. Clin Pharmacol Ther. 2012 Mar;91(3):426-37. doi: 10.1038/clpt.2011.345. Epub 2012 Feb 15. Clin Pharmacol Ther. 2012. PMID: 22336591 Review.
Accelerated access to innovative medicines for patients in need.
Baird LG, Banken R, Eichler HG, Kristensen FB, Lee DK, Lim JC, Lim R, Longson C, Pezalla E, Salmonson T, Samaha D, Tunis S, Woodcock J, Hirsch G. Baird LG, et al. Among authors: eichler hg. Clin Pharmacol Ther. 2014 Nov;96(5):559-71. doi: 10.1038/clpt.2014.145. Epub 2014 Jul 9. Clin Pharmacol Ther. 2014. PMID: 25006877
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. 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.
"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. 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.
338 results