Using Historical Data to Support Approval of Drug Products for Ophthalmia Neonatorum: Innovative Approach Toward Evidence-Based Medicine

Autor Sun, Haihao, Temeck, Jean W., McCune, Susan K., Chambers, Wiley A.
Vydáno v JAMA Ophthalmol (2020)

Pediatric Medicine Development: An Overview and Comparison of Regulatory Processes in the European Union and United States

Autor Penkov, Dobromir, Tomasi, Paolo, Eichler, Irmgard, Murphy, Dianne, Yao, Lynne P., Temeck, Jean
Vydáno v Ther Innov Regul Sci (2017)

Extrapolation of Efficacy in Pediatric Drug Development and Evidence-based Medicine: Progress and Lessons Learned

Autor Sun, Haihao, Temeck, Jean W., Chambers, Wiley, Perkins, Ginger, Bonnel, Renan, Murphy, Dianne
Vydáno v Ther Innov Regul Sci (2017)

A Comparative Review of Waivers Granted in Pediatric Drug Development by FDA and EMA from 2007-2013

Autor Egger, Gunter F., Wharton, Gerold T., Malli, Suzanne, Temeck, Jean, Murphy, M. Dianne, Tomasi, Paolo
Vydáno v Ther Innov Regul Sci (2016)

Duration of Pediatric Clinical Trials Submitted to the US Food and Drug Administration

Autor Zimmerman, Kanecia O., Smith, P. Brian, McMahon, Ann W., Temeck, Jean, Avant, Debbie, Murphy, Dianne, McCune, Susan
Vydáno v JAMA Pediatr (2019)

Surrogate Endpoints in Pediatric Studies Submitted to the US FDA

Autor Green, Dionna J., Sun, Haihao, Burnham, Janelle, Liu, Xiaomei I., van den Anker, John, Temeck, Jean, Yao, Lynne, McCune, Susan K., Burckart, Gilbert J.
Vydáno v Clin Pharmacol Ther (2018)