Bayesian Methods in Human Drug and Biological Products Development in CDER and CBER

por Ionan, Alexei C., Clark, Jennifer, Travis, James, Amatya, Anup, Scott, John, Smith, James P., Chattopadhyay, Somesh, Salerno, Mary Jo, Rothmann, Mark
Publicado 2022

Innovations in Pediatric Therapeutics Development: Principles for the Use of Bridging Biomarkers in Pediatric Extrapolation

por Fleming, Thomas R., Garnett, Christine E., Conklin, Laurie S., Corriol-Rohou, Solange, Hariharan, Sudharshan, Hsu, Daphne, Mueller-Velten, Guenther, Mulugeta, Yeruk, Portman, Ronald, Rothmann, Mark D., Stockbridge, Norman L., Wandel, Simon, Zhang, Jialu, Yao, Lynne
Publicado 2022