Model-Based Drug Development: Basics and Its Application
-
- Hasegawa Chihiro
- Clinical Pharmacology, Translational Medicine Center, Ono Pharmaceutical Co., Ltd.
-
- Sasaki Tomohiro
- Clinical PK/PD Department, Clinical Development, Medicine & QRPE Div., Nippon Boehringer Ingelheim Co., Ltd.
Bibliographic Information
- Other Title
-
- Model-Based Drug Developmentの基礎および実例紹介
- Model-Based Drug Development ノ キソ オヨビ ジツレイ ショウカイ
Search this article
Description
In drug development, the low productivity causing escalated costs has been documented for over the past decade. To overcome this significant challenge, Model-Based Drug Development (MBDD) is considered as one of the opportunities. MBDD is the drug development based on the integrated pharmaco-statistical models of drug efficacy and safety with available data and their application to inform development strategy, trial design and decision-making in the drug development. MBDD covers overall drug development stage including both pre-clinical and clinical stage and improves knowledge management and decision-making in a quantitative manner. This article introduces basics of MBDD from the theoretical and the practical point of view with some examples and shows its application for the clinical drug development of the anti-diabetes drug.
Journal
-
- Japanese Journal of Biometrics
-
Japanese Journal of Biometrics 36 (Special_Issue), S65-S84, 2015
The Biometric Society of Japan
- Tweet
Details 詳細情報について
-
- CRID
- 1390282679346477440
-
- NII Article ID
- 130005097965
-
- NII Book ID
- AA11591618
-
- ISSN
- 21856494
- 09184430
-
- NDL BIB ID
- 026672176
-
- Text Lang
- ja
-
- Data Source
-
- JaLC
- NDL Search
- Crossref
- CiNii Articles
-
- Abstract License Flag
- Disallowed