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

par Sun, Haihao, Temeck, Jean W., McCune, Susan K., Chambers, Wiley A.
Publié dans JAMA Ophthalmol (2020)

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

par Penkov, Dobromir, Tomasi, Paolo, Eichler, Irmgard, Murphy, Dianne, Yao, Lynne P., Temeck, Jean
Publié dans Ther Innov Regul Sci (2017)

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

par Sun, Haihao, Temeck, Jean W., Chambers, Wiley, Perkins, Ginger, Bonnel, Renan, Murphy, Dianne
Publié dans Ther Innov Regul Sci (2017)

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

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

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

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

Surrogate Endpoints in Pediatric Studies Submitted to the US FDA

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