Dr. Naoto Hayashi, Ph.D., M.Sc. - IDA Co., Ltd. - Associate Director/Regulatory Strategy

Dr. Naoto Hayashi

Ph.D., M.Sc.

IDA Co., Ltd.

Associate Director/Regulatory Strategy

Tokyo, Tokyo | Japan

Main Specialties: Pharmacology

Additional Specialties: Clinical Pharmacology

ORCID logohttps://orcid.org/0000-0002-6925-7037

Dr. Naoto Hayashi, Ph.D., M.Sc. - IDA Co., Ltd. - Associate Director/Regulatory Strategy

Dr. Naoto Hayashi

Ph.D., M.Sc.

Introduction

Primary Affiliation: IDA Co., Ltd. - Tokyo, Tokyo , Japan

Specialties:

Additional Specialties:

Research Interests:

Education

Oct 2001
Kyushu University
PhD
Pharmaceutical sciences
Mar 1988
Tokyo University of Science
MSc
Biological Science
Apr 1982 - Mar 1986
Tokyo University of Science
BSc
Biological Science

Experience

Jun 2017 - Jun 2017
Integrated Development Associates Co., Ltd.
Associate Director
Regulatory Strategy
Nov 2007
Pfizer Limited, UK
Director
Clinical Pharmacologist
Jun 2004
Novartis Pharma AG, Switzerland
Senior Clinical Pharmacologist
Apr 2002
F. Hoffman - La Roche AG, Switzerland
Clinical Pharmacologist

Publications

11Publications

695Reads

135Profile Views

53PubMed Central Citations

NC-6004 Phase I study in combination with gemcitabine for advanced solid tumors and population PK/PD analysis.

Cancer Chemother Pharmacol 2017 03 21;79(3):569-578. Epub 2017 Feb 21.

Exploratory Oncology Research and Clinical Trial Center, National Cancer Center Hospital East, Chiba, Japan.

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http://dx.doi.org/10.1007/s00280-017-3254-4DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5344954PMC
March 2017
155 Reads
2 Citations
2.769 Impact Factor

The Background and progress of pharmacometrics

Authors:
Naoto Hayashi

Clinical Evaluation (2013): 296-301.

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June 2013
13 Reads

Safety, tolerability and pharmacokinetics of an intravenous bolus of sildenafil in patients with pulmonary arterial hypertension.

Br J Clin Pharmacol 2011 Feb;71(2):289-92

Pulmonary Hypertension and Heart Failure Clinic, Hôpital Erasme, Brussels, Belgium.

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http://dx.doi.org/10.1111/j.1365-2125.2010.03831.xDOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3040551PMC
February 2011
15 Reads
11 Citations
3.878 Impact Factor

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: 191-198.

Japanese Journal of Clinical Pharmacology and Therapeutics

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June 2010
15 Reads

A mechanism-based binding model for the population pharmacokinetics and pharmacodynamics of omalizumab.

Br J Clin Pharmacol 2007 May 10;63(5):548-61. Epub 2006 Nov 10.

Drug Metabolism and Pharmacokinetics, Novartis Pharma AG, Basel, Switzerland.

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http://dx.doi.org/10.1111/j.1365-2125.2006.02803.xDOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2000760PMC
May 2007
249 Reads
40 Citations
3.878 Impact Factor

PK/PD analysis in clinical development process

Authors:
Naoto Hayashi

Drug Metabolism and Pharmacokinetics (2005) 20: 8-12.

Drug Metabolism and Pharmacokinetics

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June 2005
10 Reads

Estimation of rhG-CSF absorption kinetics after subcutaneous administration using a modified Wagner-Nelson method with a nonlinear elimination model.

Eur J Pharm Sci 2001 May;13(2):151-8

Clinical Pharmacology Section, Clinical Research & Development Division, Chugai Pharmaceutical Co., Ltd., 1-9, Kyobashi 2-Chome, Chuo-Ku, 104-8301, Tokyo, Japan.

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http://dx.doi.org/10.1016/s0928-0987(00)00219-0DOI Listing
May 2001
78 Reads
3.350 Impact Factor

Pharmacokinetic and pharmacodynamic analysis of subcutaneous recombinant human granulocyte colony stimulating factor (lenograstim) administration.

J Clin Pharmacol 1999 Jun;39(6):583-92

Clinical Pharmacology Section, Chugai Pharmaceutical Co., Ltd., Tokyo, Japan.

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http://dx.doi.org/10.1177/00912709922008191DOI Listing
June 1999
49 Reads

Pharmacokinetic analysis of subcutaneous erythropoietin administration with nonlinear mixed effect model including endogenous production.

Br J Clin Pharmacol 1998 Jul;46(1):11-9

Clinical Pharmacology Section, Clinical Research & Development Division, Chugai Pharmaceutical Co., Ltd., Tokyo, Japan.

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http://www.ncbi.nlm.nih.gov/pmc/articles/PMC1873985PMC
http://dx.doi.org/10.1046/j.1365-2125.1998.00043.xDOI Listing
July 1998
149 Reads
3.878 Impact Factor

Top co-authors

H Kinoshita
H Kinoshita

Hyogo College of Medicine

3
E Yukawa
E Yukawa

Kyushu University

3
Yuko Tsukamoto
Yuko Tsukamoto

Tokai University School of Medicine

1
Robert Naeije
Robert Naeije

Erasme University Hospital

1
Xiang Gao
Xiang Gao

The Pennsylvania State University

1
William M Sallas
William M Sallas

Norvastis Pharmaceuticals Corporation

1
S Ohdo
S Ohdo

Kyushu University

1
Gary Layton
Gary Layton

ParamStat Ltd

1
H Aso
H Aso

Shirakawa Institute of Animal Genetics

1
Philip J Lowe
Philip J Lowe

Novartis Pharma AG

1