Biblio

Found 35 results
2016
G. Hirsch, Trusheim, M., Cobbs, E., Bala, M., Garner, S., Hartman, D., Isaacs, K., Lumpkin, M., Lim, R., Oye, K., Pezalla, E., Saltonstall, P., and Selker, H., Adaptive Biomedical Innovation: Evolving Our Global System to Sustainably and Safely Bring New Medicines to Patients in Need, Clinical Pharmacology & Therapeutics, vol. 100, pp. 685–698, 2016.
G. K. Raju, Gurumurthi, K., Domike, R., Kazandjian, D., Blumenthal, G., Pazdur, R., and Woodcock, J., A Benefit–Risk Analysis Approach to Capture Regulatory Decision-Making: Non-Small Cell Lung Cancer, Clinical Pharmacology & Therapeutics, vol. 100, pp. 672–684, 2016.
J. C. Bouvy, Jonsson, P., Longson, C., Crabb, N., and Garner, S., Health Technology Assessment in the Context of Adaptive Pathways for Medicines in Europe: Challenges and Opportunities, Clinical Pharmacology & Therapeutics, vol. 100, pp. 594–597, 2016.
, Barone, P. W., Bellisario, A., Cooney, C. L., Sharp, P. A., Sinskey, A. J., Natesan, S., and Springs, S. L., Leveraging Industry-Academia Collaborations in Adaptive Biomedical Innovation, Clinical Pharmacology & Therapeutics, vol. 100, pp. 647–653, 2016.
D. Schulthess, Baird, L. G., Trusheim, M., Unger, T. F., Lumpkin, M., Hoos, A., Garner, S., Gavin, P., Goldman, M., Seigneuret, N., Chlebus, M., Van Baelen, K., Bergstrom, R., and Hirsch, G., Medicines Adaptive Pathways to Patients (MAPPs): A Story of International Collaboration Leading to Implementation, Therapeutic Innovation & Regulatory Science, vol. 50, pp. 347-354, 2016.
K. A. Oye, Eichler, H. G., Hoos, A., Mori, Y., Mullin, T. M., and Pearson, M., Pharmaceuticals Licensing and Reimbursement in the European Union, United States, and Japan, Clinical Pharmacology & Therapeutics, vol. 100, pp. 626–632, 2016.
M. R. Trusheim, Shrier, A. A., Antonijevic, Z., Beckman, R. A., Campbell, R. K., Chen, C., Flaherty, K. T., Loewy, J., Lacombe, D., Madhavan, S., Selker, H. P., and Esserman, L. J., PIPELINEs: Creating Comparable Clinical Knowledge Efficiently by Linking Trial Platforms, Clinical Pharmacology & Therapeutics, vol. 100, pp. 713–729, 2016.
H. - G. Eichler, Bloechl-Daum, B., Bauer, P., Bretz, F., Brown, J., Hampson, L. V., Honig, P., Krams, M., Leufkens, H., Lim, R., Lumpkin, M. M., Murphy, M. J., Pignatti, F., Posch, M., Schneeweiss, S., Trusheim, M., and Koenig, F., “Threshold-crossing”: A Useful Way to Establish the Counterfactual in Clinical Trials?, Clinical Pharmacology & Therapeutics, vol. 100, pp. 699–712, 2016.

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