Research on regulatory environment for pharmaceutical development to improve success rates of new drug development
| Project/Area Number |
20590100
|
|---|
| Research Category |
Grant-in-Aid for Scientific Research (C)
|
| Allocation Type | Single-year Grants |
|---|
| Section | 一般 |
|---|
| Research Field |
Drug development chemistry
|
|---|
| Research Institution | The University of Tokyo |
|---|
Principal Investigator |
ONO Shunsuke 東京大学, 大学院・薬学系研究科, 准教授 (40345591)
|
|---|
| Project Period (FY) |
2008 – 2012
|
| Project Status |
Completed (Fiscal Year 2012)
|
| Budget Amount *help |
¥4,550,000 (Direct Cost: ¥3,500,000、Indirect Cost: ¥1,050,000)
Fiscal Year 2012: ¥650,000 (Direct Cost: ¥500,000、Indirect Cost: ¥150,000)
Fiscal Year 2011: ¥910,000 (Direct Cost: ¥700,000、Indirect Cost: ¥210,000)
Fiscal Year 2010: ¥910,000 (Direct Cost: ¥700,000、Indirect Cost: ¥210,000)
Fiscal Year 2009: ¥910,000 (Direct Cost: ¥700,000、Indirect Cost: ¥210,000)
Fiscal Year 2008: ¥1,170,000 (Direct Cost: ¥900,000、Indirect Cost: ¥270,000)
|
|---|
| Keywords | 薬学 / レギュラトリーサイエンス / 医薬品開発 / 臨床試験 / 規制環境 / ドラッグラグ / 成功確率 / 開発戦略 / 製薬 / 市販後安全性 / 医薬品臨床開発 / 市販後安全 / 臨床開発 / 医薬品開発規制 / clinicaltrials. gov |
|---|
| Research Abstract |
This research has found a significant positive association between launch delay and success rates of new drug development in the era of global development, which enables us to propose effective R&D policy measures based on the underlying mechanism of profit maximization under uncertainty. We also have found that the global pharmaceutical development and regulatory environment, including implementation of post-marketing surveillance just after launching, seem to have impact on drug safety and dose-setting for the Japanese population. These findings help establish new drug development regulation and policies.
|
Report
(7 results)
Research Products
(97 results)
