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Acceleration of drug development: a collaboration of many stakeholders.

Clinical pharmacology and therapeutics

Reynolds KS.
PMID: 23689207
Clin Pharmacol Ther. 2013 Jun;93(6):455-9. doi: 10.1038/clpt.2013.63.

Modern drugs are used to treat and prevent diseases that previously led to morbidity and mortality. There is a high cost to this achievement--investment for each successful drug can exceed $1.8 billion. Late-phase drug candidate failure decreases efficiency of...

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Reynolds KS. Acceleration of drug development: a collaboration of many stakeholders. Clin Pharmacol Ther. 2013;93(6):455-9doi: 10.1038/clpt.2013.63.
Reynolds, K. S. (2013). Acceleration of drug development: a collaboration of many stakeholders. Clinical pharmacology and therapeutics, 93(6), 455-9. https://doi.org/10.1038/clpt.2013.63
Reynolds, K S. "Acceleration of drug development: a collaboration of many stakeholders." Clinical pharmacology and therapeutics vol. 93,6 (2013): 455-9. doi: https://doi.org/10.1038/clpt.2013.63
Reynolds KS. Acceleration of drug development: a collaboration of many stakeholders. Clin Pharmacol Ther. 2013 Jun;93(6):455-9. doi: 10.1038/clpt.2013.63. PMID: 23689207.
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Mobile medical applications: old wine in new bottles?.

Clinical pharmacology and therapeutics

Epstein RS.
PMID: 24747235
Clin Pharmacol Ther. 2014 May;95(5):476-8. doi: 10.1038/clpt.2014.35.

In Her, the award-winning motion picture written and directed by Spike Jonze, the lead character played by Joaquin Phoenix falls hopelessly in love with an operating system deployed on his many devices, including his mobile telephone. Although the health-care...

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Epstein RS. Mobile medical applications: old wine in new bottles?. Clin Pharmacol Ther. 2014;95(5):476-8doi: 10.1038/clpt.2014.35.
Epstein, R. S. (2014). Mobile medical applications: old wine in new bottles?. Clinical pharmacology and therapeutics, 95(5), 476-8. https://doi.org/10.1038/clpt.2014.35
Epstein, R S. "Mobile medical applications: old wine in new bottles?." Clinical pharmacology and therapeutics vol. 95,5 (2014): 476-8. doi: https://doi.org/10.1038/clpt.2014.35
Epstein RS. Mobile medical applications: old wine in new bottles?. Clin Pharmacol Ther. 2014 May;95(5):476-8. doi: 10.1038/clpt.2014.35. PMID: 24747235.
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A resource for facilitating the development of tools in the education and implementation of genomics-informed personalized medicine.

Clinical pharmacology and therapeutics

Zhang C, Qin C, Tao L, Zhu F, Chen SY, Zhang P, Yang SY, Wei YQ, Chen YZ.
PMID: 24556782
Clin Pharmacol Ther. 2014 Jun;95(6):590-1. doi: 10.1038/clpt.2014.39. Epub 2014 Feb 20.

No abstract available.

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Zhang C, Qin C, Tao L, et al. A resource for facilitating the development of tools in the education and implementation of genomics-informed personalized medicine. Clin Pharmacol Ther. 2014;95(6):590-1doi: 10.1038/clpt.2014.39.
Zhang, C., Qin, C., Tao, L., Zhu, F., Chen, S. Y., Zhang, P., Yang, S. Y., Wei, Y. Q., & Chen, Y. Z. (2014). A resource for facilitating the development of tools in the education and implementation of genomics-informed personalized medicine. Clinical pharmacology and therapeutics, 95(6), 590-1. https://doi.org/10.1038/clpt.2014.39
Zhang, C, et al. "A resource for facilitating the development of tools in the education and implementation of genomics-informed personalized medicine." Clinical pharmacology and therapeutics vol. 95,6 (2014): 590-1. doi: https://doi.org/10.1038/clpt.2014.39
Zhang C, Qin C, Tao L, Zhu F, Chen SY, Zhang P, Yang SY, Wei YQ, Chen YZ. A resource for facilitating the development of tools in the education and implementation of genomics-informed personalized medicine. Clin Pharmacol Ther. 2014 Jun;95(6):590-1. doi: 10.1038/clpt.2014.39. Epub 2014 Feb 20. PMID: 24556782.
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Optimizing cancer care: is the future bright?.

Clinical pharmacology and therapeutics

Zahedi P, De Souza R, Piquette-Miller M.
PMID: 21862960
Clin Pharmacol Ther. 2011 Sep;90(3):347-50. doi: 10.1038/clpt.2011.167.

No abstract available.

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Zahedi P, De Souza R, Piquette-Miller M. Optimizing cancer care: is the future bright?. Clin Pharmacol Ther. 2011;90(3):347-50doi: 10.1038/clpt.2011.167.
Zahedi, P., De Souza, R., & Piquette-Miller, M. (2011). Optimizing cancer care: is the future bright?. Clinical pharmacology and therapeutics, 90(3), 347-50. https://doi.org/10.1038/clpt.2011.167
Zahedi, P, et al. "Optimizing cancer care: is the future bright?." Clinical pharmacology and therapeutics vol. 90,3 (2011): 347-50. doi: https://doi.org/10.1038/clpt.2011.167
Zahedi P, De Souza R, Piquette-Miller M. Optimizing cancer care: is the future bright?. Clin Pharmacol Ther. 2011 Sep;90(3):347-50. doi: 10.1038/clpt.2011.167. PMID: 21862960.
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Erratum: Model-Informed Drug Development and Review for Generic Products: Summary of FDA Public Workshop.

Clinical pharmacology and therapeutics

[No authors listed]
PMID: 30347450
Clin Pharmacol Ther. 2018 Nov;104(5):1030. doi: 10.1002/cpt.1207. Epub 2018 Aug 27.

No abstract available.

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Erratum: Model-Informed Drug Development and Review for Generic Products: Summary of FDA Public Workshop. Clin Pharmacol Ther. 2018;104(5):1030doi: 10.1002/cpt.1207.
(2018). Erratum: Model-Informed Drug Development and Review for Generic Products: Summary of FDA Public Workshop. Clinical pharmacology and therapeutics, 104(5), 1030. https://doi.org/10.1002/cpt.1207
"Erratum: Model-Informed Drug Development and Review for Generic Products: Summary of FDA Public Workshop." Clinical pharmacology and therapeutics vol. 104,5 (2018): 1030. doi: https://doi.org/10.1002/cpt.1207
Erratum: Model-Informed Drug Development and Review for Generic Products: Summary of FDA Public Workshop. Clin Pharmacol Ther. 2018 Nov;104(5):1030. doi: 10.1002/cpt.1207. Epub 2018 Aug 27. PMID: 30347450.
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Impact of Brexit on UK and EU Drug Regulation and Patient Access.

Clinical pharmacology and therapeutics

Breckenridge A, Feldschreiber P.
PMID: 30346627
Clin Pharmacol Ther. 2019 Apr;105(4):923-925. doi: 10.1002/cpt.1261. Epub 2018 Nov 22.

The chronology of the United Kingdom (UK) leaving the European Union (EU) is presented together with its implications for medicines regulation, including the move of the European Medicines Agency from London (UK) to Amsterdam (the Netherlands). The legal and...

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Breckenridge A, Feldschreiber P. Impact of Brexit on UK and EU Drug Regulation and Patient Access. Clin Pharmacol Ther. 2018;105(4):923-925doi: 10.1002/cpt.1261.
Breckenridge, A., & Feldschreiber, P. (2019). Impact of Brexit on UK and EU Drug Regulation and Patient Access. Clinical pharmacology and therapeutics, 105(4), 923-925. https://doi.org/10.1002/cpt.1261
Breckenridge, Alasdair, and Feldschreiber, Peter. "Impact of Brexit on UK and EU Drug Regulation and Patient Access." Clinical pharmacology and therapeutics vol. 105,4 (2019): 923-925. doi: https://doi.org/10.1002/cpt.1261
Breckenridge A, Feldschreiber P. Impact of Brexit on UK and EU Drug Regulation and Patient Access. Clin Pharmacol Ther. 2019 Apr;105(4):923-925. doi: 10.1002/cpt.1261. Epub 2018 Nov 22. PMID: 30346627.
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CORRIGENDUM: Implementing Pharmacogenomics in Europe: Design and Implementation Strategy of the Ubiquitous Pharmacogenomics Consortium.

Clinical pharmacology and therapeutics

van der Wouden CH, Cambon-Thomsen A, Cecchin E, Cheung KC, Dávila-Fajardo CL, Deneer VH, Dolžan V, Ingelman-Sundberg M, Jönsson S, Karlsson MO, Kriek M, Mitropoulou C, Patrinos GP, Pirmohamed M, Samwald M, Schaeffeler E, Schwab M, Steinberger D, Stingl J, Sunder-Plassmann G, Toffoli G, Turner RM, van Rhenen MH, Swen JJ, Guchelaar HJ.
PMID: 30239993
Clin Pharmacol Ther. 2017 Jul;102(1):152. doi: 10.1002/cpt.725.

No abstract available.

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van der Wouden CH, Cambon-Thomsen A, Cecchin E, et al. CORRIGENDUM: Implementing Pharmacogenomics in Europe: Design and Implementation Strategy of the Ubiquitous Pharmacogenomics Consortium. Clin Pharmacol Ther. 2017;102(1):152doi: 10.1002/cpt.725.
van der Wouden, C. H., Cambon-Thomsen, A., Cecchin, E., Cheung, K. C., Dávila-Fajardo, C. L., Deneer, V. H., Dolžan, V., Ingelman-Sundberg, M., Jönsson, S., Karlsson, M. O., Kriek, M., Mitropoulou, C., Patrinos, G. P., Pirmohamed, M., Samwald, M., Schaeffeler, E., Schwab, M., Steinberger, D., Stingl, J., Sunder-Plassmann, G., Toffoli, G., Turner, R. M., van Rhenen, M. H., Swen, J. J., Guchelaar, H. J. (2017). CORRIGENDUM: Implementing Pharmacogenomics in Europe: Design and Implementation Strategy of the Ubiquitous Pharmacogenomics Consortium. Clinical pharmacology and therapeutics, 102(1), 152. https://doi.org/10.1002/cpt.725
van der Wouden, C H, et al. "CORRIGENDUM: Implementing Pharmacogenomics in Europe: Design and Implementation Strategy of the Ubiquitous Pharmacogenomics Consortium." Clinical pharmacology and therapeutics vol. 102,1 (2017): 152. doi: https://doi.org/10.1002/cpt.725
van der Wouden CH, Cambon-Thomsen A, Cecchin E, Cheung KC, Dávila-Fajardo CL, Deneer VH, Dolžan V, Ingelman-Sundberg M, Jönsson S, Karlsson MO, Kriek M, Mitropoulou C, Patrinos GP, Pirmohamed M, Samwald M, Schaeffeler E, Schwab M, Steinberger D, Stingl J, Sunder-Plassmann G, Toffoli G, Turner RM, van Rhenen MH, Swen JJ, Guchelaar HJ. CORRIGENDUM: Implementing Pharmacogenomics in Europe: Design and Implementation Strategy of the Ubiquitous Pharmacogenomics Consortium. Clin Pharmacol Ther. 2017 Jul;102(1):152. doi: 10.1002/cpt.725. PMID: 30239993.
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Minimum Technical Data Elements for Liquid Biopsy Data Submitted to Public Databases.

Clinical pharmacology and therapeutics

Febbo PG, Martin AM, Scher HI, Barrett JC, Beaver JA, Beresford PJ, Blumenthal GM, Bramlett K, Compton C, Dittamore R, Eberhard DA, Edelstein D, Godsey J, Gruen A, Hanlon SE, Hicks J, Hovelson D, Hullings M, Johann D, Johnson J, Kolatkar A, Kuhn P, Levine R, Martini JF, Miller DP, Moore C, Moy B, Pathak A, Philip R, Reese D, Royalty W, Ryder M, Sakul H, Salvatore LM, Schade A, Silvestro A, Simmons JK, Simons J, Singh Bhan S, Smalley MD, Somiari SB, Talasaz A, Tewari M, Tseng HR, Vinson J, Wells W, Welsh A, Grossman RL, Lee JSH, Leiman LC.
PMID: 32017048
Clin Pharmacol Ther. 2020 Apr;107(4):730-734. doi: 10.1002/cpt.1747. Epub 2020 Feb 04.

No abstract available.

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Febbo PG, Martin AM, Scher HI, et al. Minimum Technical Data Elements for Liquid Biopsy Data Submitted to Public Databases. Clin Pharmacol Ther. 2020;107(4):730-734doi: 10.1002/cpt.1747.
Febbo, P. G., Martin, A. M., Scher, H. I., Barrett, J. C., Beaver, J. A., Beresford, P. J., Blumenthal, G. M., Bramlett, K., Compton, C., Dittamore, R., Eberhard, D. A., Edelstein, D., Godsey, J., Gruen, A., Hanlon, S. E., Hicks, J., Hovelson, D., Hullings, M., Johann, D., Johnson, J., Kolatkar, A., Kuhn, P., Levine, R., Martini, J. F., Miller, D. P., Moore, C., Moy, B., Pathak, A., Philip, R., Reese, D., Royalty, W., Ryder, M., Sakul, H., Salvatore, L. M., Schade, A., Silvestro, A., Simmons, J. K., Simons, J., Singh Bhan, S., Smalley, M. D., Somiari, S. B., Talasaz, A., Tewari, M., Tseng, H. R., Vinson, J., Wells, W., Welsh, A., Grossman, R. L., Lee, J. S. H., & Leiman, L. C. (2020). Minimum Technical Data Elements for Liquid Biopsy Data Submitted to Public Databases. Clinical pharmacology and therapeutics, 107(4), 730-734. https://doi.org/10.1002/cpt.1747
Febbo, Phillip G, et al. "Minimum Technical Data Elements for Liquid Biopsy Data Submitted to Public Databases." Clinical pharmacology and therapeutics vol. 107,4 (2020): 730-734. doi: https://doi.org/10.1002/cpt.1747
Febbo PG, Martin AM, Scher HI, Barrett JC, Beaver JA, Beresford PJ, Blumenthal GM, Bramlett K, Compton C, Dittamore R, Eberhard DA, Edelstein D, Godsey J, Gruen A, Hanlon SE, Hicks J, Hovelson D, Hullings M, Johann D, Johnson J, Kolatkar A, Kuhn P, Levine R, Martini JF, Miller DP, Moore C, Moy B, Pathak A, Philip R, Reese D, Royalty W, Ryder M, Sakul H, Salvatore LM, Schade A, Silvestro A, Simmons JK, Simons J, Singh Bhan S, Smalley MD, Somiari SB, Talasaz A, Tewari M, Tseng HR, Vinson J, Wells W, Welsh A, Grossman RL, Lee JSH, Leiman LC. Minimum Technical Data Elements for Liquid Biopsy Data Submitted to Public Databases. Clin Pharmacol Ther. 2020 Apr;107(4):730-734. doi: 10.1002/cpt.1747. Epub 2020 Feb 04. PMID: 32017048; PMCID: PMC7158216.
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Current Statistical Considerations and Regulatory Perspectives on the Planning of Confirmatory Basket, Umbrella, and Platform Trials.

Clinical pharmacology and therapeutics

Collignon O, Gartner C, Haidich AB, James Hemmings R, Hofner B, Pétavy F, Posch M, Rantell K, Roes K, Schiel A.
PMID: 32017052
Clin Pharmacol Ther. 2020 May;107(5):1059-1067. doi: 10.1002/cpt.1804. Epub 2020 Apr 01.

Master protocols have received a growing interest during the last years. By assigning patients to specific substudies, they aim at targeting and accelerating clinical development. Given their complexity, basket, umbrella, and platform designs have raised challenging regulatory and statistical...

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Collignon O, Gartner C, Haidich AB, et al. Current Statistical Considerations and Regulatory Perspectives on the Planning of Confirmatory Basket, Umbrella, and Platform Trials. Clin Pharmacol Ther. 2020;107(5):1059-1067doi: 10.1002/cpt.1804.
Collignon, O., Gartner, C., Haidich, A. B., James Hemmings, R., Hofner, B., Pétavy, F., Posch, M., Rantell, K., Roes, K., & Schiel, A. (2020). Current Statistical Considerations and Regulatory Perspectives on the Planning of Confirmatory Basket, Umbrella, and Platform Trials. Clinical pharmacology and therapeutics, 107(5), 1059-1067. https://doi.org/10.1002/cpt.1804
Collignon, Olivier, et al. "Current Statistical Considerations and Regulatory Perspectives on the Planning of Confirmatory Basket, Umbrella, and Platform Trials." Clinical pharmacology and therapeutics vol. 107,5 (2020): 1059-1067. doi: https://doi.org/10.1002/cpt.1804
Collignon O, Gartner C, Haidich AB, James Hemmings R, Hofner B, Pétavy F, Posch M, Rantell K, Roes K, Schiel A. Current Statistical Considerations and Regulatory Perspectives on the Planning of Confirmatory Basket, Umbrella, and Platform Trials. Clin Pharmacol Ther. 2020 May;107(5):1059-1067. doi: 10.1002/cpt.1804. Epub 2020 Apr 01. PMID: 32017052.
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Virtual Twins: Understanding the Data Required for Model-Informed Precision Dosing.

Clinical pharmacology and therapeutics

Polasek TM, Rostami-Hodjegan A.
PMID: 32056199
Clin Pharmacol Ther. 2020 Apr;107(4):742-745. doi: 10.1002/cpt.1778. Epub 2020 Feb 14.

No abstract available.

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Polasek TM, Rostami-Hodjegan A. Virtual Twins: Understanding the Data Required for Model-Informed Precision Dosing. Clin Pharmacol Ther. 2020;107(4):742-745doi: 10.1002/cpt.1778.
Polasek, T. M., & Rostami-Hodjegan, A. (2020). Virtual Twins: Understanding the Data Required for Model-Informed Precision Dosing. Clinical pharmacology and therapeutics, 107(4), 742-745. https://doi.org/10.1002/cpt.1778
Polasek, Thomas M, and Rostami-Hodjegan, Amin. "Virtual Twins: Understanding the Data Required for Model-Informed Precision Dosing." Clinical pharmacology and therapeutics vol. 107,4 (2020): 742-745. doi: https://doi.org/10.1002/cpt.1778
Polasek TM, Rostami-Hodjegan A. Virtual Twins: Understanding the Data Required for Model-Informed Precision Dosing. Clin Pharmacol Ther. 2020 Apr;107(4):742-745. doi: 10.1002/cpt.1778. Epub 2020 Feb 14. PMID: 32056199.
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Evaluating the Use of Nonrandomized Real-World Data Analyses for Regulatory Decision Making.

Clinical pharmacology and therapeutics

Franklin JM, Glynn RJ, Martin D, Schneeweiss S.
PMID: 30636285
Clin Pharmacol Ther. 2019 Apr;105(4):867-877. doi: 10.1002/cpt.1351. Epub 2019 Feb 25.

The analysis of longitudinal healthcare data outside of highly controlled parallel-group randomized trials, termed real-world evidence (RWE), has received increasing attention in the medical literature. In this paper, we discuss the potential role of RWE in drug regulation with...

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Franklin JM, Glynn RJ, Martin D, et al. Evaluating the Use of Nonrandomized Real-World Data Analyses for Regulatory Decision Making. Clin Pharmacol Ther. 2019;105(4):867-877doi: 10.1002/cpt.1351.
Franklin, J. M., Glynn, R. J., Martin, D., & Schneeweiss, S. (2019). Evaluating the Use of Nonrandomized Real-World Data Analyses for Regulatory Decision Making. Clinical pharmacology and therapeutics, 105(4), 867-877. https://doi.org/10.1002/cpt.1351
Franklin, Jessica M, et al. "Evaluating the Use of Nonrandomized Real-World Data Analyses for Regulatory Decision Making." Clinical pharmacology and therapeutics vol. 105,4 (2019): 867-877. doi: https://doi.org/10.1002/cpt.1351
Franklin JM, Glynn RJ, Martin D, Schneeweiss S. Evaluating the Use of Nonrandomized Real-World Data Analyses for Regulatory Decision Making. Clin Pharmacol Ther. 2019 Apr;105(4):867-877. doi: 10.1002/cpt.1351. Epub 2019 Feb 25. PMID: 30636285.
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The Role of Quantitative Systems Pharmacology in the Design of First-in-Human Trials.

Clinical pharmacology and therapeutics

van der Graaf PH, Benson N.
PMID: 29943816
Clin Pharmacol Ther. 2018 Nov;104(5):797. doi: 10.1002/cpt.1145. Epub 2018 Jul 14.

No abstract available.

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van der Graaf PH, Benson N. The Role of Quantitative Systems Pharmacology in the Design of First-in-Human Trials. Clin Pharmacol Ther. 2018;104(5):797doi: 10.1002/cpt.1145.
van der Graaf, P. H., & Benson, N. (2018). The Role of Quantitative Systems Pharmacology in the Design of First-in-Human Trials. Clinical pharmacology and therapeutics, 104(5), 797. https://doi.org/10.1002/cpt.1145
van der Graaf, Piet H, and Benson, Neil. "The Role of Quantitative Systems Pharmacology in the Design of First-in-Human Trials." Clinical pharmacology and therapeutics vol. 104,5 (2018): 797. doi: https://doi.org/10.1002/cpt.1145
van der Graaf PH, Benson N. The Role of Quantitative Systems Pharmacology in the Design of First-in-Human Trials. Clin Pharmacol Ther. 2018 Nov;104(5):797. doi: 10.1002/cpt.1145. Epub 2018 Jul 14. PMID: 29943816.
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Showing 25 to 36 of 520 entries