Author:
Buatois Simon,Ueckert Sebastian,Frey Nicolas,Retout Sylvie,Mentré France
Publisher
Springer Science and Business Media LLC
Reference28 articles.
1. Cross J, Lee H, Westelinck A, Nelson J, Grudzinskas C, Peck C. Postmarketing drug dosage changes of 499 FDA-approved new molecular entities, 1980–1999. Pharmacoepidemiol Drug Saf. 2002;11(6):439–46.
2. Sacks LV, Shamsuddin HH, Yasinskaya YI, Bouri K, Lanthier ML, Sherman RE. Scientific and regulatory reasons for delay and denial of FDA approval of initial applications for new drugs, 2000–2012. JAMA. 2014;311(4):378–84.
3. Musuamba FT, Manolis E, Holford N, Cheung S, Friberg LE, Ogungbenro K, et al. Advanced methods for dose and regimen finding during drug development: summary of the EMA/EFPIA workshop on dose finding (London 4–5 December 2014). CPT Pharmacomet Syst Pharmacol. 2017;6(7):418–29.
4. Dose-response information to support drug registration (ICH Harmonized Tripartite Guideline), Page 2. 1994 [cited 2017 Jun 14]. Available from:
http://www.ich.org/products/guidelines/efficacy/efficacy-single/article/dose-response-information-to-support-drug-registration.html
5. Bornkamp B, Bretz F, Dmitrienko A, Enas G, Gaydos B, Hsu C-H, et al. Innovative approaches for designing and analyzing adaptive dose-ranging trials. J Biopharm Stat. 2007;17(6):965–95.
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