書誌事項
- タイトル別名
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- Early Detection of Important Safety Information
- ジュウヨウ ナ アンゼン セイジョウホウ オ ソウキ ニ ケンシュツ スル シクミ シグナル ケンシュツ ノ サイキン ノ シュホウ ニ ツイテ
- Early detection of important safety information—recent methods for signal detection.
- Early detection of important safety information -recent methods for signal detection
- —シグナル検出の最近の手法について—
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説明
It is very important to provide safety information of new drugs to physicians and patients as soon as possible after the early postmarketing period. For that purpose, it is important to appropriately collect and analyze the spontaneous reports accumulated in databases of companies and regulatory agencies. This paper reviews the analytical methods to assess spontaneous reports. Bate et al. (1998) presented Bayesian Confidence Propagation Neural Network (BCPNN) Method used by Uppsala Monitoring Centre (UMC) of the World Health Organization (WHO). DuMouchel (1999) presented Gamma-Poisson Shrinker (GPS) Program of U. S. Food and Drug Administration (FDA), and Evans et al. (2001) presented Proportional Reporting Ratios (PRR) of the Medicines Control Agency (MCA). Furthermore, DuMouchel and Pregibon (2001) extended the GPS Program, proposing the Multi-Item Gamma Poisson Shrinker (MGPS) Program, which then became the standard method for the FDA. This report also reviews the practical problems (e.g. database, duplication cases, code of Medical Dictionary for Regulatory Activities (MedDRA)) encountered in Japan.
収録刊行物
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- 計量生物学
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計量生物学 25 (1), 37-60, 2004
日本計量生物学会
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詳細情報 詳細情報について
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- CRID
- 1390282679347653888
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- NII論文ID
- 10013357940
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- NII書誌ID
- AA11591618
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- ISSN
- 21856494
- 09184430
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- NDL書誌ID
- 7033510
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- 本文言語コード
- ja
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- データソース種別
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- JaLC
- NDLサーチ
- Crossref
- CiNii Articles
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- 抄録ライセンスフラグ
- 使用不可