HAYASHI Naoto

ハヤシナオト | HAYASHI Naoto

Research field (1)： Pharmacology

Research keywords (2)： Pharmacometrics , Clinical Pharmacology

Papers (15)：

Toshihiko Doi, Tetsuya Hamaguchi, Kohei Shitara, Satoru Iwasa, Yasuhiro Shimada, Mitsunori Harada, Kenichiro Naito, Naoto Hayashi, Atsuhiro Masada, Atsushi Ohtsu. NC-6004 Phase I study in combination with gemcitabine for advanced solid tumors and population PK/PD analysis. CANCER CHEMOTHERAPY AND PHARMACOLOGY. 2017. 79. 3. 569-578
Jean-Luc Vachiery, Sandrine Huez, Hunter Gillies, Gary Layton, Naoto Hayashi, Xiang Gao, Robert Naeije. Safety, tolerability and pharmacokinetics of an intravenous bolus of sildenafil in patients with pulmonary arterial hypertension. British Journal of Clinical Pharmacology. 2011. 71. 2. 289-292
Watt, S, Hayashi, N, Harnish, L, Gao, X. Population pharmacokinetics (PK) of sildenafil in paediatric and adult patients with pulmonary arterial hypertension (PAH). European Society of Cardiology. 2010
J. -L. Vachiery, S. Huez, H. Gillies, G. Layton, N. Hayashi, X. Gao, R. Naeije. Safety and Tolerability of a 10-mg Intravenous Bolus Sildenafil Dose in Patients With Pulmonary Arterial Hypertension and Comparison of its Pharmacokinetics With a 20-mg Oral Sildenafil Dose. AMERICAN JOURNAL OF RESPIRATORY AND CRITICAL CARE MEDICINE. 2010. 181. A3358-A3358
Naoto Hayashi, Lutz Harnisch. Population PK of Sildenafil and PK/PD assessment of Exercise tolerability in children with Pulmonary Arterial Hypertension (PAH). Population Aproach Group in Europe. 2009

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MISC (7)：

Naoto HAYASHI. The prospect of atacicept treatment in SLE patients - based on the results of Study APRIL and other information -. Rheumatology Jpn. 2015. 53. 5. 522-530
Naoto HAYASHI. The Background and progress of pharmacometrics. Clinical Evaluation. 2013. 40. 2. 296-301
Naoto HAYASHI. Background, history and the relationship of pharmacometrics with Clinical pharmacology. Japanese journal of clinical pharmacology and therapeutics. 2013. 44. S189-S189
Naoto Hayashi. Usefulness of modeling and simulation techniques in clinical development process, and the background and current situation in overseas countries. Japanese Journal of Clinical Pharmacology and Therapeutics. 2010. 41. 5. 191-198
Naoto HAYASHI. Point to consider for setting dose and keeping validity with PK/PD modeling. Pharm Stage. 2007. 7. 3. 26-30

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Books (2)：

Dose Setting in Clinical Studies and Managing Risk in Clinical Development.
Science & Technology 2013 ISBN:9784864280686
S-PLUSによる混合効果モデル解析
丸善出版 2012 ISBN:9784621062562

Lectures and oral presentations (7)：

PK/PD Analysis for Antibody Drugs with Mechanism-Based Binding Model
(30th Annual Meeting of The Japanese Society for the Study of Xenobiotics 2015)
Background, history and the relationship of pharmacometrics with Clinical pharmacology
(34th annual meeting of Japan Society of Clinical Pharmacology and Therapeutics 2013)
Background, progress and application of Pharmacometrics
(2nd International Symposium of Early Stage Clinical Trial 2012)
Utility of M&S in Clinical Development and its circumstance in Europe and US.
(Symposium in 30th annual meeting of Japan society of Clinical Pharmacology and Therapeutics 2009)
Population PK of Sildenafil and PK/PD Assessment of Exercise Tolerability in Children with Pulmonary Arterial Hypertension (PAH)
(18th annual meeting of Population Approach Group in Europe 2009)

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Works (8)：

Approval of new indicaiton of Erbitux® to treat head and neck cancer in Japan
- 2012
Approval of the intravenous formulation of Revatio® by the European Commission
- 2010
Approval of Xolair® for asthma in Japan
- 2009
Approval of Lucentis® to treat age-related macular edema in Japan
- 2009
Approval of Certican® in Organ Transplant Recipients in Japan
- 2007

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Education (2)：

1986 - 1988 Science University of Tokyo Graduate School of Science & Engineering Faculty of Applied biological science
1982 - 1986 Science University of Tokyo Department of Science and engineering Faculty of Applied biological science

Professional career (2)：

Work history (14)：

2022/01 - 2022/04 Certara Companies Integrated Drug Development Senior Director - Clinical Pharmacologist
2017/06 - 2020/06 Integrated Development Associates, Co. Ltd. Regulatory Strategy Associate Director
2015/09 - 2016/08 Nanocarrier Co., Ltd. DIrector in charge of international development and clinical pharmacology
2010 - 2015/08 Merck Serono Co., Ltd. Clinical Development Center Clinical pharmacologist
2007 - 2009 Pfizer Limited, UK Director / Clinical Pharmacologist

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Committee career (1)：

2012/11 - 現在 Japan Society of Clinical Pharmacology and Therapeuticcs Member of council

Association Membership(s) (1)：

THE JAPANESE SOCIETY OF CLINICAL PHARMACOLOGY AND THERAPEUTICS

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