Model-Based Drug Developmentの基礎および実例紹介
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| Published in | 計量生物学 Vol. 36; no. Special_Issue; pp. S65 - S84 |
|---|---|
| Main Authors | , |
| Format | Journal Article |
| Language | Japanese |
| Published |
日本計量生物学会
2015
|
| Online Access | Get full text |
| ISSN | 0918-4430 2185-6494 |
| DOI | 10.5691/jjb.36.S65 |
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| Author | 佐々木, 智啓 長谷川, 千尋 |
|---|---|
| Author_xml | – sequence: 1 fullname: 長谷川, 千尋 organization: 小野薬品工業株式会社トランスレーショナルメディシンセンタークリニカルファーマコロジー部 – sequence: 1 fullname: 佐々木, 智啓 organization: 日本ベーリンガーインゲルハイム株式会社医薬開発本部臨床薬物動態部 |
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| Copyright | 2015 日本計量生物学会 |
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| DOI | 10.5691/jjb.36.S65 |
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| References | Nathan D.M., Kuenen J., Borg R., Zheng H., Schoenfeld D., Heine R.J. and A1c-Derived Average Glucose Study Group (2008). Translating the A1C assay into estimated average glucose values. Diabetes Care, 31, 1473-1478. Hay M., Thomas D.W., Craighead J.L., Economides C. and Rosenthal J. (2014). Clinical development success rates for investigational drugs. Nature Biotechnology, 32(1), 40-51. Ahn J.E. and French J.L. (2010). Longitudinal aggregate data model-based meta-analysis with NONMEM: approaches to handling within treatment arm correlation. Journal of Pharmacokinetics and Pharmacodynamics, 37, 179-201. Lalovic B., Hutmacher M., Frame B. and Miller R. (2011). Modeling dropout from adverse event data: impact of dosing regimens across pregabalin trials in the treatment of generalized anxiety disorder. The Journal of Clinical Pharmacology. 51(5), 706-718. Kenna L.A., Labbé L., Barrett J.S. and Pfister M. (2005). Modeling and simulation of adherence: approaches and applications in therapeutics. The AAPS Journal, 7(2), E390-E407. Dayneka N.L., Garg V. and Jusko W.J. (1993). Comparison of four basic models of indirect pharmacodynamic responses. Journal of Pharmacokinetics and Biopharmaceutics, 21(4), 457-478. Milligan P.A., Brown M.J., Marchant B., Martin S.W., van der Graaf P.H., Benson N., Nucci G., Nichols D.J., Boyd R.A., Mandema J.W., Krishnaswami S., Zwillich S., Gruben D., Anziano R.J., Stock T.C. and Lalonde R.L. (2013). Model-based drug development: a rational approach to effciently accelerate drug development. Clinical Pharmacology & Therapeutics, 93, 502-514. Hamrén B., Björk E., Sunzel M. and Karlsson M. (2008). Models for plasma glucose, HbA1c, and hemoglobin interrelationships in patients with type 2 diabetes following tesaglitazar treatment. Clinical Pharmacology & Therapeutics, 84, 228-235. Woodcock J. and Woosley R. (2008). The FDA critical path initiative and its influence on new drug development. Annual Review of Medicine, 59, 1-12. Jauslin P.M., Frey N. and Karlsson M.O. (2011). Modeling of 24-hour glucose and insulin profiles of patients with type 2 diabetes. The Journal of Clinical Pharmacology, 51, 153-164. Slayter K.L., Ludwig E.A., Lew K.H., Middleton E., Ferry J.J. and Jusko W.J. (1996). Oral contraceptive effects on methylprednisolone pharmacokinetics and pharmacodynamics. Clinical Pharmacology & Therapeutics, 59, 312-321. Gobburu J.V. and Lesko L.J. (2009). Quantitative disease, drug, and trial models. Annual Review of Pharmacology and Toxicology, 49, 291-301. Harnisch L., Matthews I., Chard J. and Karlsson M.O. (2013). Drug and disease model resources: a consortium to create standards and tools to enhance model-based drug development. CPT: Pharmacometrics & Systems Pharmacology, 2, e34. Hasegawa C., Nakade S., Ohno T., Komaba J. and Ogawa M. (2013). Modeling & simulation of ONO-4641, a sphingosine 1-phosphate receptor modulator, to support dose selection with phase 1 data [Population Approach Group in Europe 2013, Glasgow]. http://www.page-meeting.org/?abstract=2820. Accessed September 4, 2014. Lavielle M. (2014). Mixed effects models for the population approach: models, tasks, methods and tools. New York: Chapman and Hall/CRC Press. Lalonde R.L., Kowalski K.G., Hutmacher M.M., Ewy W., Nichols D.J., Milligan P.A., Corrigan B.W., Lockwood P.A., Marshall S.A., Benincosa L.J., Tensfeldt T.G., Parivar K., Amantea M., Glue P., Koide H. and Miller R. (2007). Model-based drug development. Clinical Pharmacology & Therapeutics, 82(1), 21-32. Ohno T., Hasegawa C., Nakade S., Kitagawa J., Honda N. and Ogawa M. (2010). The prediction of human response to ONO-4641, a sphingosine 1-phosphate receptor modulator, from preclinical data based on pharmacokinetic-pharmacodynamic modeling. Biopharmaceutics & Drug Disposition, 31(7), 396-406. |
| References_xml | – reference: Harnisch L., Matthews I., Chard J. and Karlsson M.O. (2013). Drug and disease model resources: a consortium to create standards and tools to enhance model-based drug development. CPT: Pharmacometrics & Systems Pharmacology, 2, e34. – reference: Lavielle M. (2014). Mixed effects models for the population approach: models, tasks, methods and tools. New York: Chapman and Hall/CRC Press. – reference: Lalonde R.L., Kowalski K.G., Hutmacher M.M., Ewy W., Nichols D.J., Milligan P.A., Corrigan B.W., Lockwood P.A., Marshall S.A., Benincosa L.J., Tensfeldt T.G., Parivar K., Amantea M., Glue P., Koide H. and Miller R. (2007). Model-based drug development. Clinical Pharmacology & Therapeutics, 82(1), 21-32. – reference: Milligan P.A., Brown M.J., Marchant B., Martin S.W., van der Graaf P.H., Benson N., Nucci G., Nichols D.J., Boyd R.A., Mandema J.W., Krishnaswami S., Zwillich S., Gruben D., Anziano R.J., Stock T.C. and Lalonde R.L. (2013). Model-based drug development: a rational approach to effciently accelerate drug development. Clinical Pharmacology & Therapeutics, 93, 502-514. – reference: Hasegawa C., Nakade S., Ohno T., Komaba J. and Ogawa M. (2013). Modeling & simulation of ONO-4641, a sphingosine 1-phosphate receptor modulator, to support dose selection with phase 1 data [Population Approach Group in Europe 2013, Glasgow]. http://www.page-meeting.org/?abstract=2820. Accessed September 4, 2014. – reference: Dayneka N.L., Garg V. and Jusko W.J. (1993). Comparison of four basic models of indirect pharmacodynamic responses. Journal of Pharmacokinetics and Biopharmaceutics, 21(4), 457-478. – reference: Ohno T., Hasegawa C., Nakade S., Kitagawa J., Honda N. and Ogawa M. (2010). The prediction of human response to ONO-4641, a sphingosine 1-phosphate receptor modulator, from preclinical data based on pharmacokinetic-pharmacodynamic modeling. Biopharmaceutics & Drug Disposition, 31(7), 396-406. – reference: Slayter K.L., Ludwig E.A., Lew K.H., Middleton E., Ferry J.J. and Jusko W.J. (1996). Oral contraceptive effects on methylprednisolone pharmacokinetics and pharmacodynamics. Clinical Pharmacology & Therapeutics, 59, 312-321. – reference: Nathan D.M., Kuenen J., Borg R., Zheng H., Schoenfeld D., Heine R.J. and A1c-Derived Average Glucose Study Group (2008). Translating the A1C assay into estimated average glucose values. Diabetes Care, 31, 1473-1478. – reference: Ahn J.E. and French J.L. (2010). Longitudinal aggregate data model-based meta-analysis with NONMEM: approaches to handling within treatment arm correlation. Journal of Pharmacokinetics and Pharmacodynamics, 37, 179-201. – reference: Woodcock J. and Woosley R. (2008). The FDA critical path initiative and its influence on new drug development. Annual Review of Medicine, 59, 1-12. – reference: Hamrén B., Björk E., Sunzel M. and Karlsson M. (2008). Models for plasma glucose, HbA1c, and hemoglobin interrelationships in patients with type 2 diabetes following tesaglitazar treatment. Clinical Pharmacology & Therapeutics, 84, 228-235. – reference: Kenna L.A., Labbé L., Barrett J.S. and Pfister M. (2005). Modeling and simulation of adherence: approaches and applications in therapeutics. The AAPS Journal, 7(2), E390-E407. – reference: Lalovic B., Hutmacher M., Frame B. and Miller R. (2011). Modeling dropout from adverse event data: impact of dosing regimens across pregabalin trials in the treatment of generalized anxiety disorder. The Journal of Clinical Pharmacology. 51(5), 706-718. – reference: Jauslin P.M., Frey N. and Karlsson M.O. (2011). Modeling of 24-hour glucose and insulin profiles of patients with type 2 diabetes. The Journal of Clinical Pharmacology, 51, 153-164. – reference: Gobburu J.V. and Lesko L.J. (2009). Quantitative disease, drug, and trial models. Annual Review of Pharmacology and Toxicology, 49, 291-301. – reference: Hay M., Thomas D.W., Craighead J.L., Economides C. and Rosenthal J. (2014). Clinical development success rates for investigational drugs. Nature Biotechnology, 32(1), 40-51. |
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| Title | Model-Based Drug Developmentの基礎および実例紹介 |
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