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The Use of External Controls in FDA Regulatory Decision Making.
Jahanshahi M, Gregg K, Davis G, Ndu A, Miller V, Vockley J, Ollivier C, Franolic T, Sakai S. Jahanshahi M, et al. Among authors: ollivier c. Ther Innov Regul Sci. 2021 Sep;55(5):1019-1035. doi: 10.1007/s43441-021-00302-y. Epub 2021 May 20. Ther Innov Regul Sci. 2021. PMID: 34014439 Free PMC article. Review.
Paediatric investigation plans for pain: painfully slow!
Davies EH, Ollivier CM, Saint Raymond A. Davies EH, et al. Eur J Clin Pharmacol. 2010 Nov;66(11):1091-7. doi: 10.1007/s00228-010-0886-2. Epub 2010 Sep 7. Eur J Clin Pharmacol. 2010. PMID: 20821198 Free article.
Pediatric Extrapolation in Type 2 Diabetes: Future Implications of a Workshop.
Barrett JS, Bucci-Rechtweg C, Amy Cheung SY, Gamalo-Siebers M, Haertter S, Karres J, Marquard J, Mulugeta Y, Ollivier C, Strougo A, Yanoff L, Yao L, Zeitler P. Barrett JS, et al. Among authors: ollivier c. Clin Pharmacol Ther. 2020 Jul;108(1):29-39. doi: 10.1002/cpt.1805. Epub 2020 Mar 16. Clin Pharmacol Ther. 2020. PMID: 32017043 Free PMC article.
Paediatric extrapolation: A necessary paradigm shift.
Ollivier C, Mulugeta YL, Ruggieri L, Saint-Raymond A, Yao L. Ollivier C, et al. Br J Clin Pharmacol. 2019 Apr;85(4):675-679. doi: 10.1111/bcp.13809. Epub 2018 Dec 18. Br J Clin Pharmacol. 2019. PMID: 30403304 Free PMC article. Review.
New Strategies for the Conduct of Clinical Trials in Pediatric Pulmonary Arterial Hypertension: Outcome of a Multistakeholder Meeting With Patients, Academia, Industry, and Regulators, Held at the European Medicines Agency on Monday, June 12, 2017.
Ollivier C, Sun H, Amchin W, Beghetti M, Berger RMF, Breitenstein S, Garnett C, Gullberg N, Hassel P, Ivy D, Kawut SM, Klein A, Lesage C, Migdal M, Nije B, Odermarsky M, Strait J, de Graeff PA, Stockbridge N. Ollivier C, et al. J Am Heart Assoc. 2019 May 21;8(10):e011306. doi: 10.1161/JAHA.118.011306. J Am Heart Assoc. 2019. PMID: 31088189 Free PMC article. No abstract available.
174 results