scholarly journals Dose Selection in a Pandemic: A Framework Informed by the FDA Animal Rule

2020 ◽  
Author(s):  
Kunyi Wu ◽  
Kimberly L. Bergman
Keyword(s):  
Dose Selection ◽  
Animal Rule

Antimicrobial Dose Selection under the Animal Rule

2021 ◽  
Vol 109 (4) ◽  
pp. 971-976 ◽  
Author(s):  
Kunyi Wu ◽  
Su‐Young Choi ◽  
Kimberly Bergman ◽  
Shirley Seo
Keyword(s):  
Dose Selection ◽  
Animal Rule

scholarly journals Neonatal and Pediatric Dose Selection: Quo Vadis?

2021 ◽  
Vol 61 (S1) ◽  
Author(s):  
Gilbert J. Burckart ◽  
John N. den Anker
Keyword(s):  
Dose Selection ◽  
Pediatric Dose ◽  
Quo Vadis

scholarly journals Progress in Drug Development–Pediatric Dose Selection: Workshop Summary

2021 ◽  
Vol 61 (S1) ◽  
Author(s):  
Jian Wang ◽  
John N. den Anker ◽  
Gilbert J. Burckart
Keyword(s):  
Drug Development ◽  
Dose Selection ◽  
Pediatric Dose ◽  
Workshop Summary

scholarly journals A Call for Objective Dose Selection to Increase Success in Pediatric Clinical Trials: A Perspective From NICHD and NIMH Program Staff

2021 ◽  
Vol 61 (S1) ◽  
Author(s):  
George Giacoia ◽  
Margaret C. Grabb ◽  
Aaron C. Pawlyk ◽  
Zhaoxia Ren ◽  
Lesly Samedy‐Bates ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Dose Selection ◽  
Program Staff

scholarly journals Approaches to Modelling the Human Immune Response in Transition of Candidates from Research to Development

2014 ◽  
Vol 2014 ◽  
pp. 1-6 ◽  
Author(s):  
Diane Williamson
Keyword(s):  
Immune Response ◽  
Human Immune Response ◽  
Human Immune ◽  
Animal Rule

This review considers the steps required to evaluate a candidate biodefense vaccine or therapy as it emerges from the research phase, in order to transition it to development. The options for preclinical modelling of efficacy are considered in the context of the FDA’s Animal Rule.

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