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

Yazar: Sun, Haihao, Temeck, Jean W., McCune, Susan K., Chambers, Wiley A.
Yayımlandı JAMA Ophthalmol (2020)

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

Yazar: Penkov, Dobromir, Tomasi, Paolo, Eichler, Irmgard, Murphy, Dianne, Yao, Lynne P., Temeck, Jean
Yayımlandı Ther Innov Regul Sci (2017)

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

Yazar: Sun, Haihao, Temeck, Jean W., Chambers, Wiley, Perkins, Ginger, Bonnel, Renan, Murphy, Dianne
Yayımlandı Ther Innov Regul Sci (2017)

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

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

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

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

Surrogate Endpoints in Pediatric Studies Submitted to the US FDA

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