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

Por Sun, Haihao, Temeck, Jean W., McCune, Susan K., Chambers, Wiley A.
Publicado no JAMA Ophthalmol (2020)

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

Por Penkov, Dobromir, Tomasi, Paolo, Eichler, Irmgard, Murphy, Dianne, Yao, Lynne P., Temeck, Jean
Publicado no Ther Innov Regul Sci (2017)

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

Por Sun, Haihao, Temeck, Jean W., Chambers, Wiley, Perkins, Ginger, Bonnel, Renan, Murphy, Dianne
Publicado no Ther Innov Regul Sci (2017)

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

Por Egger, Gunter F., Wharton, Gerold T., Malli, Suzanne, Temeck, Jean, Murphy, M. Dianne, Tomasi, Paolo
Publicado no Ther Innov Regul Sci (2016)

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

Por Zimmerman, Kanecia O., Smith, P. Brian, McMahon, Ann W., Temeck, Jean, Avant, Debbie, Murphy, Dianne, McCune, Susan
Publicado no JAMA Pediatr (2019)

Surrogate Endpoints in Pediatric Studies Submitted to the US FDA

Por Green, Dionna J., Sun, Haihao, Burnham, Janelle, Liu, Xiaomei I., van den Anker, John, Temeck, Jean, Yao, Lynne, McCune, Susan K., Burckart, Gilbert J.
Publicado no Clin Pharmacol Ther (2018)