薬剤疫学の基礎と実践　改訂第3版

出版社： ライフサイエンス出版
著者：
発行日： 2021-07-23
分野： 薬学  >  薬学一般
ISBN： 9784897754390
電子書籍版： 2021-07-23 （改定第3版）
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5年ぶりの改訂版！
医学・薬学の研究者，製薬企業・行政機関で医薬品の安全性について担当する方，ファーマコビジランス・スペシャリスト（医薬品の安全性評価のスペシャリスト）を目指す方の必読書です！
本書を読めば……
・薬剤疫学研究により得られた成果である重要な薬剤の副作用の内容を理解できます。
・薬剤疫学研究の中心となる観察研究の手法について学ぶことができます。
そして……
・自ら薬剤疫学研究を行う際の方法論を身につけることができます。

目次

  • 1章 薬剤疫学の役割
    2章 薬剤疫学研究により明らかにされた薬効と安全性
    3章 薬害
    4章 研究デザイン
    5章 薬剤疫学研究の計画
    6章 販売承認前の臨床試験（治験）と市販後の調査・試験
    7章 制度
    8章 関連領域
    9章 ファーマコビジランス・スペシャリスト

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参考文献のリンクは、リンク先の都合等により正しく表示されない場合がありますので、あらかじめご了承下さい。

本参考文献は電子書籍掲載内容を元にしております。

1章 薬剤疫学の役割

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2章 薬剤疫学研究により明らかにされた薬効と安全性

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3章 薬害

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6章 販売承認前の臨床試験 ( 治験 ) と市販後の調査・試験

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25. 医薬品医療機器総合機構. G-CSF製剤の「使用上の注意」の改訂について(2020年3月31日). https://www.pmda.go.jp/files/000234643.pdf
 
26. 柴田大朗. 患者レジストリデータを医薬品等の承認申請資料等として活用する場合におけるデータの信頼性担保に関する提言. 薬理と治療 2019;47 Suppl:s9-s12.
 

7章 制度

P.324 掲載の参考文献
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2. 厚生労働省. 医薬品, 医療機器等の品質, 有効性及び安全性の確保等に関する法律等の一部を改正する法律案の概要. 2019. https://www.mhlw.go.jp/content/000491532.pdf
 
P.351 掲載の参考文献
1. 厚生労働省. 再生医療等製品及び生物由来製品に関する感染症定期報告制度について(薬生発0428第1号 平成29年4月28日). https://www.pmda.go.jp/files/000217923.pdf
 
2. 厚生労働省. 医薬関係者からの医薬品の副作用等報告における電子報告システムの活用について:別添「医薬品・医療機器等安全性情報報告制度」実施要領(薬生発0325第22号 令和3年3月25日). https://www.mhlw.go.jp/hourei/doc/tsuchi/T210405I0090.pdf
 
3. 厚生労働省医薬・生活衛生局. 患者副作用報告について. 医薬品・医療機器等安全性情報 No. 363令和元年(2019年)6月. https://www.pmda.go.jp/files/000229790.pdf#page=3
 
4. 厚生労働省. 患者からの医薬品副作用報告について(薬生安発0326第1号 平成31年3月26日). https://www.pmda.go.jp/files/000228707.pdf
 
5. 厚生労働省. 医薬部外品, 化粧品, 医療機器及び再生医療等製品の製造販売後安全管理の基準に関する省令(厚生労働省令第135号 平成16年9月22日).
 
6. 厚生労働省. 医薬品リスク管理計画の策定について(薬食審査発0426第2号・薬食安発0426第1号 平成24年4月26日, 薬生薬審発1205第1号・薬生安発1205第1号 平成29年12月5日にて一部改正).
 
7. 厚生労働省. 医薬品リスク管理計画指針について(薬食安発0411第1号・薬食審査発0411第2号 平成24年4月11日). https://www.pmda.go.jp/files/000145482.pdf
 
8. 厚生労働省医薬食品局. 「医薬品リスク管理計画」の実施について. 医薬品・医療機器等安全性情報No. 300. 平成25年(2013年)3月. https://www.pmda.go.jp/files/000143744.pdf#page=3
 
9. 厚生労働省. 医療用医薬品の市販直後調査の実施方法等について(薬食安発第0324001号 平成18年3月24日). https://www.pmda.go.jp/files/000145855.pdf
 
10. 厚生労働省. 医療用医薬品の再審査期間について(薬生発0831第11号 令和2年8月31日). https://www.mhlw.go.jp/content/11120000/000665702.pdf
 
11. 厚生労働省. 再審査期間の取扱いについて(生薬審発0831第16号 令和2年8月31日). https://www.mhlw.go.jp/content/11120000/000665723.pdf
 
12. 厚生労働省. 新医療用医薬品に関する安全性定期報告制度について(薬生発0831第5号 令和2年8月31日). https://www.mhlw.go.jp/content/11120000/000665697.pdf
 
13. 厚生労働省. 医薬品の製造販売後の調査及び試験の実施の基準に関する省令(厚生労働省令第171号 平成16年12月20日).
 
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2. 厚生労働省医薬・生活衛生局. 医薬品・医療機器等安全性情報No. 377. 令和2年(2020年)11月. https://www.pmda.go.jp/files/000237301.pdf
 
P.363 掲載の参考文献
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2. 厚生労働省. 医薬品安全性監視の計画について(薬食審査発0916001号 平成17年9月16日). https://www.pmda.go.jp/files/000156059.pdf
 
3. 厚生労働省. 定期的ベネフィット・リスク評価報告(PBRER)について(薬食審査発0517第1号 平成25年5月17日). https://www.pmda.go.jp/files/000143944.pdf
 
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6. European Medicines Agency(EMA). Guideline on good pharmacovigilance practices(GVP):Module IX-Signal management(Rev 1). https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-good-pharmacovigilance-practices-gvp-module-ix-signal-management-rev-1_en.pdf
 
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8章 関連領域

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