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How to Interpret an Investigator's Brochure for Meaningful Risk Assessment: Results of an AGAH Discussion Forum.
Ther Innov Regul Sci. 2021 May;55(3):612-618. doi: 10.1007/s43441-021-00257-0. Epub 2021 Feb 3.
Ther Innov Regul Sci. 2021.
PMID: 33537954
Free PMC article.
Unintended drug exposure during pregnancy in clinical trials - a survey in early drug development.
Erb-Zohar K, Sourgens H, Breithaupt-Groegler K, Klipping C.
Erb-Zohar K, et al. Among authors: breithaupt groegler k.
Int J Clin Pharmacol Ther. 2021 Jan;59(1):26-30. doi: 10.5414/CP203788.
Int J Clin Pharmacol Ther. 2021.
PMID: 33141016
Free PMC article.
Clinical Trial.
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Use of integrated clinical trial protocols - A survey in early medicines development
.
Erb-Zohar K, Sourgens H, Breithaupt-Groegler K.
Erb-Zohar K, et al. Among authors: breithaupt groegler k.
Int J Clin Pharmacol Ther. 2018 May;56(5):205-211. doi: 10.5414/CP203206.
Int J Clin Pharmacol Ther. 2018.
PMID: 29451470
Free PMC article.
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Who is a 'healthy subject'?-consensus results on pivotal eligibility criteria for clinical trials.
Breithaupt-Groegler K, Coch C, Coenen M, Donath F, Erb-Zohar K, Francke K, Goehler K, Iovino M, Kammerer KP, Mikus G, Rengelshausen J, Sourgens H, Schinzel R, Sudhop T, Wensing G.
Breithaupt-Groegler K, et al.
Eur J Clin Pharmacol. 2017 Apr;73(4):409-416. doi: 10.1007/s00228-016-2189-8. Epub 2017 Jan 7.
Eur J Clin Pharmacol. 2017.
PMID: 28064353
Free PMC article.
Review.
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The sodium glucose cotransporter 2 inhibitor empagliflozin does not prolong QT interval in a thorough QT (TQT) study.
Ring A, Brand T, Macha S, Breithaupt-Groegler K, Simons G, Walter B, Woerle HJ, Broedl UC.
Ring A, et al. Among authors: breithaupt groegler k.
Cardiovasc Diabetol. 2013 Apr 24;12:70. doi: 10.1186/1475-2840-12-70.
Cardiovasc Diabetol. 2013.
PMID: 23617452
Free PMC article.
Clinical Trial.
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