Dose Extrapolation

Animal-to-human dose translation of obiltoxaximab for treatment of inhalational anthrax under the US FDA animal rule.

Nagy CF, Mondick J, Serbina N, Casey LS, Carpenter SE, French J, Guttendorf R.  Clinical And Translational Science, 2016 Dec; 10: 12–19.

Efficacy projection of obiltoxaximab for treatment of inhalational anthrax across a range of disease severity

Yamamoto BJ, Shadiack AM, Carpenter S, Sanford D, Henning LN, O’Connor E, Gonzales N, Mondick J, French J, Stark GV, Fisher AC, Casey LS, Serbina NV. Antimicrob Agents Chemother 60:5787–5795. doi:10.1128/AAC.00972-16

The role of simulation in assessing extrapolation assumptions

Gastonguay MR.  Presented at the Quantitative Assessment of Assumptions to Support Extrapolation of Efficacy in Pediatrics: FDA – U Maryland CERSI Cosponsored Workshop.  FDA. June 1, 2016.

Population pharmacokinetic (PPK) modeling and simulation to support pediatric dose selection of ceftaroline fosamil (CPT-F) in children aged 28 days to 12 years

Khariton T, Riccobene T, Knebel W, O’Neal T, Ghahramani P. Presented at the 5th American Conference on Pharmacometrics (ACoP), Las Vegas, NV, October 2014.