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Showing 1 to 12 of 147 entries
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A modelling framework for improved design and decision-making in drug development.

PloS one

Wiklund SJ.
PMID: 31461440
PLoS One. 2019 Aug 28;14(8):e0220812. doi: 10.1371/journal.pone.0220812. eCollection 2019.

The development of a new drug is an extremely high-risk enterprise. The attrition rates of development projects and the average costs for each launched product are daunting, and the completion of a development program requires a very long time...

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Wiklund SJ. A modelling framework for improved design and decision-making in drug development. PLoS One. 2019;14(8):e0220812doi: 10.1371/journal.pone.0220812.
Wiklund, S. J. (2019). A modelling framework for improved design and decision-making in drug development. PloS one, 14(8), e0220812. https://doi.org/10.1371/journal.pone.0220812
Wiklund, Stig Johan. "A modelling framework for improved design and decision-making in drug development." PloS one vol. 14,8 (2019): e0220812. doi: https://doi.org/10.1371/journal.pone.0220812
Wiklund SJ. A modelling framework for improved design and decision-making in drug development. PLoS One. 2019 Aug 28;14(8):e0220812. doi: 10.1371/journal.pone.0220812. eCollection 2019. PMID: 31461440; PMCID: PMC6713335.
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Comment on Jaki et al., A proposal for a new PhD level curriculum on quantitative methods for drug development. Pharmaceutical Statistics 17 (5):593-606, Sep/Oct 2018, DOI: 10.1002/pst.1873.

Pharmaceutical statistics

Krause A, Kloft C, Huisinga W, Karlsson M, Pinheiro J, Bies R, Rogers J, Mentré F, Musser BJ.
PMID: 30932340
Pharm Stat. 2019 May;18(3):278-281. doi: 10.1002/pst.1940. Epub 2019 Apr 01.

No abstract available.

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Krause A, Kloft C, Huisinga W, et al. Comment on Jaki et al., A proposal for a new PhD level curriculum on quantitative methods for drug development. Pharmaceutical Statistics 17 (5):593-606, Sep/Oct 2018, DOI: 10.1002/pst.1873. Pharm Stat. 2019;18(3):278-281doi: 10.1002/pst.1940.
Krause, A., Kloft, C., Huisinga, W., Karlsson, M., Pinheiro, J., Bies, R., Rogers, J., Mentré, F., Musser, B. J. (2019). Comment on Jaki et al., A proposal for a new PhD level curriculum on quantitative methods for drug development. Pharmaceutical Statistics 17 (5):593-606, Sep/Oct 2018, DOI: 10.1002/pst.1873. Pharmaceutical statistics, 18(3), 278-281. https://doi.org/10.1002/pst.1940
Krause, Andreas, et al. "Comment on Jaki et al., A proposal for a new PhD level curriculum on quantitative methods for drug development. Pharmaceutical Statistics 17 (5):593-606, Sep/Oct 2018, DOI: 10.1002/pst.1873." Pharmaceutical statistics vol. 18,3 (2019): 278-281. doi: https://doi.org/10.1002/pst.1940
Krause A, Kloft C, Huisinga W, Karlsson M, Pinheiro J, Bies R, Rogers J, Mentré F, Musser BJ. Comment on Jaki et al., A proposal for a new PhD level curriculum on quantitative methods for drug development. Pharmaceutical Statistics 17 (5):593-606, Sep/Oct 2018, DOI: 10.1002/pst.1873. Pharm Stat. 2019 May;18(3):278-281. doi: 10.1002/pst.1940. Epub 2019 Apr 01. PMID: 30932340.
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Comment on Jaki et al., A proposal for a new PhD level curriculum on quantitative methods for drug development. Pharmaceutical Statistics 17(5):593-606, Sep/Oct 2018. DOI: 10.1002/pst.1873.

Pharmaceutical statistics

Burger HU.
PMID: 30912614
Pharm Stat. 2019 May;18(3):282-283. doi: 10.1002/pst.1939. Epub 2019 Mar 26.

No abstract available.

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Burger HU. Comment on Jaki et al., A proposal for a new PhD level curriculum on quantitative methods for drug development. Pharmaceutical Statistics 17(5):593-606, Sep/Oct 2018. DOI: 10.1002/pst.1873. Pharm Stat. 2019;18(3):282-283doi: 10.1002/pst.1939.
Burger, H. U. (2019). Comment on Jaki et al., A proposal for a new PhD level curriculum on quantitative methods for drug development. Pharmaceutical Statistics 17(5):593-606, Sep/Oct 2018. DOI: 10.1002/pst.1873. Pharmaceutical statistics, 18(3), 282-283. https://doi.org/10.1002/pst.1939
Burger, Hans Ulrich. "Comment on Jaki et al., A proposal for a new PhD level curriculum on quantitative methods for drug development. Pharmaceutical Statistics 17(5):593-606, Sep/Oct 2018. DOI: 10.1002/pst.1873." Pharmaceutical statistics vol. 18,3 (2019): 282-283. doi: https://doi.org/10.1002/pst.1939
Burger HU. Comment on Jaki et al., A proposal for a new PhD level curriculum on quantitative methods for drug development. Pharmaceutical Statistics 17(5):593-606, Sep/Oct 2018. DOI: 10.1002/pst.1873. Pharm Stat. 2019 May;18(3):282-283. doi: 10.1002/pst.1939. Epub 2019 Mar 26. PMID: 30912614.
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The Role of Early-Phase Design-Letter.

Clinical cancer research : an official journal of the American Association for Cancer Research

Ratain MJ.
PMID: 31092614
Clin Cancer Res. 2019 May 15;25(10):3190. doi: 10.1158/1078-0432.CCR-19-0350.

No abstract available.

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Ratain MJ. The Role of Early-Phase Design-Letter. Clin Cancer Res. 2019;25(10):3190doi: 10.1158/1078-0432.CCR-19-0350.
Ratain, M. J. (2019). The Role of Early-Phase Design-Letter. Clinical cancer research : an official journal of the American Association for Cancer Research, 25(10), 3190. https://doi.org/10.1158/1078-0432.CCR-19-0350
Ratain, Mark J. "The Role of Early-Phase Design-Letter." Clinical cancer research : an official journal of the American Association for Cancer Research vol. 25,10 (2019): 3190. doi: https://doi.org/10.1158/1078-0432.CCR-19-0350
Ratain MJ. The Role of Early-Phase Design-Letter. Clin Cancer Res. 2019 May 15;25(10):3190. doi: 10.1158/1078-0432.CCR-19-0350. PMID: 31092614.
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Drug Annotations for a New Decade.

Journal of medicinal chemistry

Young WB, Georg GI, Wang S.
PMID: 31965800
J Med Chem. 2020 Feb 13;63(3):883. doi: 10.1021/acs.jmedchem.0c00036. Epub 2020 Jan 22.

No abstract available.

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Young WB, Georg GI, Wang S. Drug Annotations for a New Decade. J Med Chem. 2020;63(3):883doi: 10.1021/acs.jmedchem.0c00036.
Young, W. B., Georg, G. I., & Wang, S. (2020). Drug Annotations for a New Decade. Journal of medicinal chemistry, 63(3), 883. https://doi.org/10.1021/acs.jmedchem.0c00036
Young, Wendy B, et al. "Drug Annotations for a New Decade." Journal of medicinal chemistry vol. 63,3 (2020): 883. doi: https://doi.org/10.1021/acs.jmedchem.0c00036
Young WB, Georg GI, Wang S. Drug Annotations for a New Decade. J Med Chem. 2020 Feb 13;63(3):883. doi: 10.1021/acs.jmedchem.0c00036. Epub 2020 Jan 22. PMID: 31965800.
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Report on the current status of the use of real-world data (RWD) and real-world evidence (RWE) in drug development and regulation.

British journal of clinical pharmacology

Breckenridge AM, Breckenridge RA, Peck CC.
PMID: 31290181
Br J Clin Pharmacol. 2019 Sep;85(9):1874-1877. doi: 10.1111/bcp.14026. Epub 2019 Jul 10.

Radically expanding use of real-world data (RWD) and real-world evidence (RWE) holds the potential to substantially impact drug development, pharmaceutical regulation, and payment within health care systems. Central to this is the reconfiguration of data gathering and transformation of...

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Breckenridge AM, Breckenridge RA, Peck CC. Report on the current status of the use of real-world data (RWD) and real-world evidence (RWE) in drug development and regulation. Br J Clin Pharmacol. 2019;85(9):1874-1877doi: 10.1111/bcp.14026.
Breckenridge, A. M., Breckenridge, R. A., & Peck, C. C. (2019). Report on the current status of the use of real-world data (RWD) and real-world evidence (RWE) in drug development and regulation. British journal of clinical pharmacology, 85(9), 1874-1877. https://doi.org/10.1111/bcp.14026
Breckenridge, Alasdair M, et al. "Report on the current status of the use of real-world data (RWD) and real-world evidence (RWE) in drug development and regulation." British journal of clinical pharmacology vol. 85,9 (2019): 1874-1877. doi: https://doi.org/10.1111/bcp.14026
Breckenridge AM, Breckenridge RA, Peck CC. Report on the current status of the use of real-world data (RWD) and real-world evidence (RWE) in drug development and regulation. Br J Clin Pharmacol. 2019 Sep;85(9):1874-1877. doi: 10.1111/bcp.14026. Epub 2019 Jul 10. PMID: 31290181; PMCID: PMC6710497.
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Improving Drug Development and Patient Access With the Right People, Processes, and Culture: What Needs to Happen Right Now to Bring Better Medicines to the Patients Who Need Them.

Therapeutic innovation & regulatory science

Grignolo A, Siu A.
PMID: 30526020
Ther Innov Regul Sci. 2019 May;53(3):398-402. doi: 10.1177/2168479018814224. Epub 2018 Dec 10.

In a global environment where health care costs are soaring, R&D efforts are flatlining. Meanwhile, payers are demanding more value for their money. In this environment, the traditional siloed drug development model is not sustainable. Yet innovations such as...

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Grignolo A, Siu A. Improving Drug Development and Patient Access With the Right People, Processes, and Culture: What Needs to Happen Right Now to Bring Better Medicines to the Patients Who Need Them. Ther Innov Regul Sci. 2018;53(3):398-402doi: 10.1177/2168479018814224.
Grignolo, A., & Siu, A. (2019). Improving Drug Development and Patient Access With the Right People, Processes, and Culture: What Needs to Happen Right Now to Bring Better Medicines to the Patients Who Need Them. Therapeutic innovation & regulatory science, 53(3), 398-402. https://doi.org/10.1177/2168479018814224
Grignolo, Alberto, and Siu, Albert. "Improving Drug Development and Patient Access With the Right People, Processes, and Culture: What Needs to Happen Right Now to Bring Better Medicines to the Patients Who Need Them." Therapeutic innovation & regulatory science vol. 53,3 (2019): 398-402. doi: https://doi.org/10.1177/2168479018814224
Grignolo A, Siu A. Improving Drug Development and Patient Access With the Right People, Processes, and Culture: What Needs to Happen Right Now to Bring Better Medicines to the Patients Who Need Them. Ther Innov Regul Sci. 2019 May;53(3):398-402. doi: 10.1177/2168479018814224. Epub 2018 Dec 10. PMID: 30526020.
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Learning for Personalized Medicine: A Comprehensive Review From a Deep Learning Perspective.

IEEE reviews in biomedical engineering

Zhang S, Bamakan SMH, Qu Q, Li S.
PMID: 30106692
IEEE Rev Biomed Eng. 2019;12:194-208. doi: 10.1109/RBME.2018.2864254. Epub 2018 Aug 07.

With the recent advancements in analyzing high-volume, complex, and unstructured data, modern learning methods are playing an increasingly critical role in the field of personalized medicine. Personalized medicine (i.e., providing tailored medical treatment to individual patients through the identification...

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Zhang S, Bamakan SMH, Qu Q, et al. Learning for Personalized Medicine: A Comprehensive Review From a Deep Learning Perspective. IEEE Rev Biomed Eng. 2018;12:194-208doi: 10.1109/RBME.2018.2864254.
Zhang, S., Bamakan, S. M. H., Qu, Q., & Li, S. (2019). Learning for Personalized Medicine: A Comprehensive Review From a Deep Learning Perspective. IEEE reviews in biomedical engineering, 12194-208. https://doi.org/10.1109/RBME.2018.2864254
Zhang, Sushen, et al. "Learning for Personalized Medicine: A Comprehensive Review From a Deep Learning Perspective." IEEE reviews in biomedical engineering vol. 12 (2019): 194-208. doi: https://doi.org/10.1109/RBME.2018.2864254
Zhang S, Bamakan SMH, Qu Q, Li S. Learning for Personalized Medicine: A Comprehensive Review From a Deep Learning Perspective. IEEE Rev Biomed Eng. 2019;12:194-208. doi: 10.1109/RBME.2018.2864254. Epub 2018 Aug 07. PMID: 30106692.
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A Statistical Roadmap for Journey from Real-World Data to Real-World Evidence.

Therapeutic innovation & regulatory science

Fang Y, Wang H, He W.
PMID: 32557297
Ther Innov Regul Sci. 2020 Jul;54(4):749-757. doi: 10.1007/s43441-019-00008-2. Epub 2019 Dec 06.

Randomized controlled clinical trials are the gold standard for evaluating the safety and efficacy of pharmaceutical drugs, but in many cases their costs, duration, limited generalizability, and ethical or technical feasibility have caused some to look for real-world studies...

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Fang Y, Wang H, He W. A Statistical Roadmap for Journey from Real-World Data to Real-World Evidence. Ther Innov Regul Sci. 2019;54(4):749-757doi: 10.1007/s43441-019-00008-2.
Fang, Y., Wang, H., & He, W. (2020). A Statistical Roadmap for Journey from Real-World Data to Real-World Evidence. Therapeutic innovation & regulatory science, 54(4), 749-757. https://doi.org/10.1007/s43441-019-00008-2
Fang, Yixin, et al. "A Statistical Roadmap for Journey from Real-World Data to Real-World Evidence." Therapeutic innovation & regulatory science vol. 54,4 (2020): 749-757. doi: https://doi.org/10.1007/s43441-019-00008-2
Fang Y, Wang H, He W. A Statistical Roadmap for Journey from Real-World Data to Real-World Evidence. Ther Innov Regul Sci. 2020 Jul;54(4):749-757. doi: 10.1007/s43441-019-00008-2. Epub 2019 Dec 06. PMID: 32557297.
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Signature-based approaches for informed drug repurposing: targeting CNS disorders.

Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology

Shukla R, Henkel ND, Alganem K, Hamoud AR, Reigle J, Alnafisah RS, Eby HM, Imami AS, Creeden JF, Miruzzi SA, Meller J, Mccullumsmith RE.
PMID: 32604402
Neuropsychopharmacology. 2021 Jan;46(1):116-130. doi: 10.1038/s41386-020-0752-6. Epub 2020 Jun 30.

CNS disorders, and in particular psychiatric illnesses, lack definitive disease-altering therapeutics. The limited understanding of the mechanisms driving these illnesses with the slow pace and high cost of drug development exacerbates this issue. For these reasons, drug repurposing -...

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Shukla R, Henkel ND, Alganem K, et al. Signature-based approaches for informed drug repurposing: targeting CNS disorders. Neuropsychopharmacology. 2020;46(1):116-130doi: 10.1038/s41386-020-0752-6.
Shukla, R., Henkel, N. D., Alganem, K., Hamoud, A. R., Reigle, J., Alnafisah, R. S., Eby, H. M., Imami, A. S., Creeden, J. F., Miruzzi, S. A., Meller, J., & Mccullumsmith, R. E. (2021). Signature-based approaches for informed drug repurposing: targeting CNS disorders. Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology, 46(1), 116-130. https://doi.org/10.1038/s41386-020-0752-6
Shukla, Rammohan, et al. "Signature-based approaches for informed drug repurposing: targeting CNS disorders." Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology vol. 46,1 (2021): 116-130. doi: https://doi.org/10.1038/s41386-020-0752-6
Shukla R, Henkel ND, Alganem K, Hamoud AR, Reigle J, Alnafisah RS, Eby HM, Imami AS, Creeden JF, Miruzzi SA, Meller J, Mccullumsmith RE. Signature-based approaches for informed drug repurposing: targeting CNS disorders. Neuropsychopharmacology. 2021 Jan;46(1):116-130. doi: 10.1038/s41386-020-0752-6. Epub 2020 Jun 30. PMID: 32604402; PMCID: PMC7688959.
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Inducing Ubiquitylation and Protein Degradation as a Drug Development Strategy.

Methods in molecular biology (Clifton, N.J.)

Dhami KS, Huang X.
PMID: 34432244
Methods Mol Biol. 2021;2365:175-184. doi: 10.1007/978-1-0716-1665-9_9.

A new drug discovery strategy by inducing the degradation of oncoproteins through ubiquitin-proteasome system (UPS) has gained a lot of traction in the last decade (Verma et al. Mol Cell 77(3):446-460, 2020; Huang, Dixit. Cell Res 26:484, 2016). Multiple...

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Dhami KS, Huang X. Inducing Ubiquitylation and Protein Degradation as a Drug Development Strategy. Methods Mol Biol. 2021;2365:175-184doi: 10.1007/978-1-0716-1665-9_9.
Dhami, K. S., & Huang, X. (2021). Inducing Ubiquitylation and Protein Degradation as a Drug Development Strategy. Methods in molecular biology (Clifton, N.J.), 2365175-184. https://doi.org/10.1007/978-1-0716-1665-9_9
Dhami, Kamaldeep S, and Huang, XiaoDong. "Inducing Ubiquitylation and Protein Degradation as a Drug Development Strategy." Methods in molecular biology (Clifton, N.J.) vol. 2365 (2021): 175-184. doi: https://doi.org/10.1007/978-1-0716-1665-9_9
Dhami KS, Huang X. Inducing Ubiquitylation and Protein Degradation as a Drug Development Strategy. Methods Mol Biol. 2021;2365:175-184. doi: 10.1007/978-1-0716-1665-9_9. PMID: 34432244.
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Estimation of treatment effect in 2-in-1 adaptive design and some of its extensions.

Statistics in medicine

Li W, Bai X, Deng Q, Liu F, Chen C.
PMID: 33723865
Stat Med. 2021 May 20;40(11):2556-2577. doi: 10.1002/sim.8917. Epub 2021 Mar 15.

The 2-in-1 adaptive design allows seamless expansion of an ongoing Phase II trial into a Phase III trial to expedite a drug development program. Since its publication, it has generated a lot of interest. So far, most of the...

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Li W, Bai X, Deng Q, et al. Estimation of treatment effect in 2-in-1 adaptive design and some of its extensions. Stat Med. 2021;40(11):2556-2577doi: 10.1002/sim.8917.
Li, W., Bai, X., Deng, Q., Liu, F., & Chen, C. (2021). Estimation of treatment effect in 2-in-1 adaptive design and some of its extensions. Statistics in medicine, 40(11), 2556-2577. https://doi.org/10.1002/sim.8917
Li, Wen, et al. "Estimation of treatment effect in 2-in-1 adaptive design and some of its extensions." Statistics in medicine vol. 40,11 (2021): 2556-2577. doi: https://doi.org/10.1002/sim.8917
Li W, Bai X, Deng Q, Liu F, Chen C. Estimation of treatment effect in 2-in-1 adaptive design and some of its extensions. Stat Med. 2021 May 20;40(11):2556-2577. doi: 10.1002/sim.8917. Epub 2021 Mar 15. PMID: 33723865.
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Showing 1 to 12 of 147 entries