Basic Concept of the 1st Section

To enhance the sophistication of drug safety management, it is necessary to improve upon existing scientific and systematic methodologies utilized for whole safety information, such as identifying case-reports of drug-induced adverse events from pharmaceutical companies and medical institutions.

Drastic changes in medical treatment by various kinds of technological advances, e.g. pharmaco-kinetics, -genetics, etc., have allowed for the opportunity to redefine regulatory management, based on the findings of these new technologies.

Major Research Subjects

The Division of Medicinal Safety Science (MSS) is engaged in the basic research on the safety of medicines. The major activities are focused on medicinal safety control in general, such as collection, analysis and evaluation of a variety of safety information including adverse reactions, and study on an appropriate drug information dispending system which is necessary to the proper use of medicines.

1. Development of scientific and systematic regulatory methodology for safety management of drug usage.

  1. Search of the latest regulatory system for drug safety management in foreign countries
  2. Improvement of information treatment strategy for case reports of drug adverse events

2. New regulatory strategy corresponding to changes of state-of-the-art scientific technology

3. Drug utilization studies.

 

Staff

Section Chief: Kimie Sai, Ph.D.

Researcher: Yuichiro Azuma, MSc.

 

Publication

1) Saito M, Hirata-Koizumi M, Miyake S, Hasegawa R.

  Comparison of information on the pharmacokinetic interactions of Ca  antagonists in the package inserts from three countries (Japan, USA and UK).

   Eur J Clin Pharmacol. 61: 531-6 (2005) abstract

 

2) Saito M, Hirata-Koizumi M, Matsumoto M, Urano T, Hasegawa R.

  Undesirable effects of citrus juice on the pharmacokinetics of drugs : focus on recent studies.

  Drug Saf. 28: 677-94 (2005) abstract

 

3) Saito M, Hirata-Koizumi M, Urano T, Miyake S, Hasegawa R.

  A literature search on pharmacokinetic drug interactions of statins and analysis of how such interactions are reflected in package inserts in Japan.

  J Clin Pharm Ther. 30: 21-37 (2005)  abstract

 

4) Hirata-Koizumi M, Saito M, Miyake S, Hasegawa R.

Adverse events caused by drug interactions involving glucuronoconjugates of zidovudine, valproic acid and lamotrigine, and analysis of how such potential events are discussed in package inserts of Japan, UK and USA.

J Clin Pharm Ther. 32: 177–85 (2007) abstract

 

5) Saito M, Azuma Y, Hasegawa R.

Post-marketing Research of Drug Safety [Article in Japanese]

Jpn J Clin Pharmacol Ther. 41: 127-31.(2010)

 

6) Saito M, Hayashi Y.

Prediction of the influenza A(H1N1) epidemic using the drug-based health vigilance system [Article in Japanese]

Folia Pharmacologica Japonica. 136: 310. (2010)

 

7) Yamada Y, Sawada Y, Yamamoto K, Iikubo T, Ohtani H, Kamimura N, Abe Y, Uehara K, Ohta T, Orii T, Kishimoto T, Saito M, Butatsu K, Taruno H, Chikazawa Y, Nakasa H, Hashiguchi M, Hori S, Yamamoto T.

The ideal focus of the study in the drug information sciences -- Problem extraction and analysis based on KJ method in the workshop --. [Article in Japanese]

Jpn J Drug Inform. 11: 76-87 (2009)

 

8) Tohkin M, Saito M, Ishiguro A, Miyake S, Suzuki M, Orii T, Hasegawa R.

Pilot Study of Data Collection System for Adverse Reactions of Prescribed Medications using Hospital Information Systems. [Article in Japanese]

Kokuritsu Iyakuhin Shokuhin Eisei Kenkyusho Hokoku. 126: 104-10 (2008)

full text

 

9) Saito M, Hayashi Y, Hasegawa R.

Investigation of the handling of conflict of interest in the US and European countries and survey of the attitudes of physicians and pharmacists towards industry – academia cooperation in Japan. [Article in Japanese]

Kokuritsu Iyakuhin Shokuhin Eisei Kenkyusho Hokoku. 126: 111-9 (2008)

full text

 

10) Saito M, Hasegawa R.

Survey of the amount of the industry funding for biomedical research -- analysis of questionnaire for medical and pharmaceutical departments, professors belonging these departments and the pharmaceutical companies.  [Article in Japanese]

Kokuritsu Iyakuhin Shokuhin Eisei Kenkyusho Hokoku. 126: 120-6 (2008)

full text

 

11) Hayashi Y, Saito M, Hasegawa R.

A role of pharmacists in bioterrorism response and preparedness. [Article in Japanese]

Jpn J Soc Pharm. 27: 11-18 (2008)

 

12) Saito M.

Introduction of gthe manual for handling disorders due to adverse drug reactionsh – focus on the antibiotics related severe adverse drug reactions. [Article in Japanese]

  The Japanese Journal of Antibiotics. 61: 269-288 (2008)

 

13) Saito M, Hirata-Koizumi M, Miyake S, Hasegawa R.

Investigation on new molecular entities of drugs approved in three regions, Japan, US and EU – common and preceding approvals in current 4 years.@ [Article in Japanese]

Kokuritsu Iyakuhin Shokuhin Eisei Kenkyusho Hokoku. 124: 80-2 (2006)

abstract

 

14) Mutsuko Hirata-Koizumi, Mitsuo Saito, Shinji Miyake, Ryuichi Hasegawa.

Study on Environmental Risk Assessment of Drugs: Excretion Forms to Environment.@ [Article in Japanese]

Kokuritsu Iyakuhin Shokuhin Eisei Kenkyusho Hokoku. 124: 83-6 (2006)

abstract 

 

15) Saito M, Hirata-Koizumi M, Miyake S, Hasegawa R.

Withdrawal of cerivastatin revealed a flaw of post-marketing surveillance system in the United States. [Article in Japanese]

Kokuritsu Iyakuhin Shokuhin Eisei Kenkyusho Hokoku. 123: 41-5 (2005)

abstract  full text

 

16) Hirata-Koizumi M, Saito M, Urano T, Miyake S, Hasegawa R.

Improvement of package insert CYP information for prescription drugs marketed in Japan. [Article in Japanese]

Kokuritsu Iyakuhin Shokuhin Eisei Kenkyusho Hokoku. 123: 12-8 (2005)

abstract  full text

 

17) Hirata-Koizumi M, Saito M, Miyake S, Hasegawa R.

Incremental effect and mechanism of cyclosporine on blood concentration of statins and statin package insert information in Japan. [Article in Japanese]

Kokuritsu Iyakuhin Shokuhin Eisei Kenkyusho Hokoku. 123: 37-40 (2005)

abstract  full text

 

Book

1) Mitsuo Saito, Ryuichi Hasegawa,

Chapter 6 - Investigation of New Molecular Entities of Drugs Approved in Three Regions; Japan, US and the EU; pp. 141-148

In: Drug Approval and Evaluation, Delivery and Control

Editors: Anna O. Hartmann and Lea K. Neumann

Publisher: Nova Science Publishers (July 2008)

ISBN-13: 978-1604565331

 

Presentation

1) Saito M.

Comparison and analysis of information on the pharmacokinetic

interactions in the package inserts

4th Asia Pacific Regional ISSX Meeting@T'ainan, Taiwan - April, 2010

 

2) Saito M, R Hasegawa.

Medicines withdrawn in the world market from 2007 to 2010 regarding the

safety issue and their status in Japan

Proceedings of the 131th Annual Meeting of the Pharmaceutical Society of

Japan (2011)

 

3) Saito M.

Update on Orphan Drugs in the US, EU, and Japan

46th DIA Annual Meeting

Washington DC, USA, June 2010

 

4) Saito M, et al.

PMDA Town Meeting

46th DIA Annual Meeting

Washington DC, USA, June 2010

 

5) Saito M, Hirata M, Miyake S, Hasegawa R.

A literature search on CYP3A4/MDR-1 mediated drug interactions involving Ca blockers and analysis of how this is reflected in labeling available in Japan, USA and UK

Proceedings of the 125th Annual Meeting of the Pharmaceutical Society of

Japan (2005)

 

6) Miyake S, Saito M, Hirata-Koizumi M, Hasegawa R.

Comparison of approval times for new prescription drugs in Japan and USA

Proceedings of the 125th Annual Meeting of the Pharmaceutical Society of

Japan (2005)

 

7) Hasegawa R, Hirata M, Saito M, Urano T.

Predictability of clinical pharmacokinetic interaction of statins with other drugs

from non-clinical data

Proceedings of the 124th Annual Meeting of the Pharmaceutical Society of

Japan (2004)

 

8) Hirata M, Matsumoto M, Saito M, Urano T, Hasegawa R.

Investigation of description related to drug interaction with grapefruit juice in

drug labeling

Proceedings of the 124th Annual Meeting of the Pharmaceutical Society of

Japan (2004)

 

9) Urano T, Hirata M, Saito M, Hasegawa R.

Study on descriptive change about Cytochrome P-450 in drug labeling

Proceedings of the 124th Annual Meeting of the Pharmaceutical Society of

Japan (2004)

 

10) Urano T, Koizumi M, Hasegawa R.

Investigation on drugs withdrawn from the market for safety reasons in foreign

countries and the safety control action against these drugs in Japan

Proceedings of the 123th Annual Meeting of the Pharmaceutical Society of

Japan (2003)