Utilization of the Bridging Strategy for the Development of New Drugs in Oncology to Avoid Drug Lag-Reference-Cited by-同舟云学术

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Utilization of the Bridging Strategy for the Development of New Drugs in Oncology to Avoid Drug Lag

Published:2017-06-19 Issue:11 Volume:57 Page:1479-1490
ISSN:0091-2700
Container-title:The Journal of Clinical Pharmacology
language:en
Short-container-title:The Journal of Clinical Pharmacology

Author:

Kogure Seiji¹²,Koyama Nobuyuki³,Hidaka Shinji¹

Affiliation:

1. Department of Pharmaceutical Regulatory Science; School of Pharmacy; Nihon University; Chiba Japan

2. Oncology Clinical Development Department; Daiichi Sankyo Co. Ltd.; Tokyo Japan

3. Clinical Data and Biostatistics Department; Daiichi Sankyo Co. Ltd.; Tokyo Japan

Publisher

Wiley

Subject

Pharmacology (medical),Pharmacology

Reference24 articles.

1. Clinical development and review times for new drugs in Japan: associated factors;Ishibashi;Clin Pharmacol Ther,2010

2. The notorious “drug lag” for oncology drugs in Japan;Yonemori;Invest New Drugs,2011

3. PMDA Town Hall New regulation in Japan and Future direction of PMDA https://www.pmda.go.jp/files/000214115.pdf 2017

4. The revision of the guideline for clinical evaluation methods of anticancer drugs in Japan;Andoh;Gan To Kagaku Ryoho,2006

5. Successful bridging strategy based on ICH E5 guideline for drugs approved in Japan;Uyama;Clin Pharmacol Ther,2005

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1. Oncology drug lag in Japan: has it improved over the last decade?;International Journal of Clinical Oncology;2023-08-10

2. Comparison of Addition of Indications for Antineoplastic Agents Approved in the United States and Japan from 2001 to 2020;Biological and Pharmaceutical Bulletin;2023-07-01

3. Oncology drug lag in Japan – Has it improved over the last decade?;2023-05-04

4. Exploratory Analysis of Drug Lag in New Oncology Drugs Between Japan and the US;Therapeutic Innovation & Regulatory Science;2023-03-25

5. Assessment of the Delay in Novel Anticancer Drugs between China and the United States: A Comparative Study of Drugs Approved between 2010 and 2021;Clinical Pharmacology & Therapeutics;2022-10-09

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