Biblio

Found 35 results
2014
L. G. Baird, Banken, R., Eichler, H. - G., Kristensen, F. B., Lee, D. K., Lim, J. C. W., Lim, R., Longson, C., Pezalla, E., Salmonson, T., Samaha, D., Tunis, S., Woodcock, J., and Hirsch, G., “Accelerated Access to Innovative Medicines for Patients in Need”, Clinical Pharmacology & Therapeutics, vol. 96, pp. 559–571, 2014.
R. J Teagarden, Unger, T. F., and Hirsch, G., “Access and availability of orphan drugs in the United States: advances or cruel hoaxes?”, Expert Opinion on Orphan Drugs, vol. 2, pp. 1147-1150, 2014.
J. R. Beshansky, Sheehan, P. R., Klima, K. J., Hadar, N., Vickery, E. M., and Selker, H. P., “A community consultation survey to evaluate support for and success of the IMMEDIATE trial”, Clinical Trials, vol. 11, pp. 178-186, 2014.
M. R. Trusheim, Baird, L. G., Garner, S., Lim, R., Patel, N., and Hirsch, G., “The Janus initiative: A multi-stakeholder process and tool set for facilitating and quantifying Adaptive Licensing discussions”, Health Policy and Technology, vol. 3, pp. 241 - 247, 2014.
2013
L. Baird and Hirsch, G., “Adaptive licensing: creating a safe haven for discussions”, Scrip Regulatory Affairs, 2013.
L. G. Baird, Trusheim, M. R., Eichler, H. - G., Berndt, E. R., and Hirsch, G., “Comparison of Stakeholder Metrics for Traditional and Adaptive Development and Licensing Approaches to Drug Development”, Therapeutic Innovation & Regulatory Science, vol. 47, pp. 474-483, 2013.
M. Papadaki and Hirsch, G., “Curing Consortium Fatigue”, Science Translational Medicine, vol. 5, pp. 200fs35–200fs35, 2013.
K. Oye, Baird, L. G., Chia, A., Hocking, S., Hutt, P. B., Lee, D., Norwalk, L., and Salvatore, V., “Legal Foundations of Adaptive Licensing”, Clinical Pharmacology & Therapeutics, vol. 94, pp. 309–311, 2013.
2012
H. - G. Eichler, Oye, K., Baird, L. G., Abadie, E., Brown, J., Drum, C. L., Ferguson, J., Garner, S., Honig, P., Hukkelhoven, M., Lim, J. C. W., Lim, R., Lumpkin, M. M., Neil, G., O'Rourke, B., Pezalla, E., Shoda, D., Seyfert-Margolis, V., Sigal, E. V., Sobotka, J., Tan, D., Unger, T. F., and Hirsch, G., “Adaptive licensing: taking the next step in the evolution of drug approval.”, Clin Pharmacol Ther, vol. 91, no. 3, pp. 426-37, 2012.
2009
J. Orloff, Douglas, F., Pinheiro, J., Levinson, S., Branson, M., Chaturvedi, P., Ette, E., Gallo, P., Hirsch, G., Mehta, C., Patel, N., Sabir, S., Springs, S., Stanski, D., Evers, M. R., Fleming, E., Singh, N., Tramontin, T., and Golub, H., “The future of drug development: advancing clinical trial design”, Nat Rev Drug Discov, vol. 8, no. 12, pp. 949 - 957, 2009.

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