Early Detection of Important Safety Information

DOI Web Site 12 Citations 47 References
  • Watanabe Hiroyuki
    Data Management and Biostatistics, Clinical Development Institute, BANYU PHARMACEUTICAL CO., LTD.
  • Matsushita Yasuyuki
    Clinical Pharmacology and Biostatistics Department, New Drug Development Division, SANKYO CO., LTD. Management Sciences Department, Faculty of Engineering, Tokyo University of Science
  • Watanabe Atsushi
    Medical and Drug Information, ELI LILLY JAPAN K.K.
  • Maeda Toshiro
    Post-Marketing Data Management Development, Pharmacovigilance Unit, Pharmacovigilance & Quality Assurance Division, Mitsubishi Pharma Corporation.
  • Nukui Kazuhiko
    Drug Safety & Post Marketing Surveillance Department, Sumitomo Pharmaceuticals Co., Ltd.
  • Ogawa Yoshimasa
    Post Marketing Surveillance Department, JANSSEN PHARMACEUTICAL K.K.
  • Sawa Jungo
    Biometrics Department, R & D Institute, Schering-Plough K.K.
  • Maeda Hiroshi
    Biostatistics and Planning, Development Division, FUJISAWA PHARAMACEUTICAL CO., LTD.

Bibliographic Information

Other Title
  • 重要な安全性情報を早期に検出する仕組み―シグナル検出の最近の手法について―
  • 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—

Search this article

Description

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.

Journal

Citations (12)*help

See more

References(47)*help

See more

Keywords

Details 詳細情報について

Report a problem

Back to top