Pregnancy and the Pharmaceutical Industry: The Movement Towards Evidence-Based Pharmacotherapy for Pregnant Women
暫譯: 懷孕與製藥產業:朝向基於證據的孕婦藥物治療運動

Shields, Kristine E.

  • 出版商: Academic Press
  • 出版日期: 2019-05-24
  • 售價: $4,590
  • 貴賓價: 9.5$4,361
  • 語言: 英文
  • 頁數: 244
  • 裝訂: Quality Paper - also called trade paper
  • ISBN: 0128185503
  • ISBN-13: 9780128185506
  • 海外代購書籍(需單獨結帳)

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商品描述

Pregnancy and the Pharmaceutical Industry: The Movement towards Evidence-Based Care for Pregnant Women explores the issues surrounding the decision to undertake clinical trials with pregnant women. There is currently a lack of data on the safety and effectiveness of medications used during pregnancy as it is impossible to extrapolate that information from drug studies on men and non-pregnant women. As a majority of pregnant women confront a medical condition during their pregnancy, from simple pain, to ongoing or new medical issues, this book quantifies the current absence of pregnant women in drug studies and identifies ethical issues, barriers, litigation fears and opportunities.

Those in the pharmaceutical industry, IRB members who approve or deny drug study plans, doctors, nurses and midwives working in obstetrics or involved in conducting studies at their institutions will find this book an essential resource.

  • Explores the medical, ethical, scientific and legal rationales behind the inclusion of pregnant women in drug studies
  • Describes how pharma and biotech companies can safely implement the new FDA guidance and begin to include pregnant women in drug testing
  • Shares views from pharmaceutical industry insiders about company risks, reluctance to implement guidance, and the ultimate need to include pregnant women in studies

商品描述(中文翻譯)

《懷孕與製藥產業:朝向基於證據的孕婦護理運動》探討了在孕婦中進行臨床試驗的決策所涉及的問題。目前,關於懷孕期間使用藥物的安全性和有效性缺乏數據,因為無法從男性和非孕婦的藥物研究中推斷這些信息。由於大多數孕婦在懷孕期間面臨醫療狀況,從簡單的疼痛到持續或新的醫療問題,本書量化了目前孕婦在藥物研究中的缺失,並識別出倫理問題、障礙、訴訟恐懼和機會。

製藥產業的從業者、審查藥物研究計劃的IRB成員、在產科工作的醫生、護士和助產士,以及參與其機構研究的專業人士,將會發現這本書是必不可少的資源。

- 探討將孕婦納入藥物研究的醫學、倫理、科學和法律依據
- 描述製藥和生技公司如何安全地實施新的FDA指導方針,並開始將孕婦納入藥物測試
- 分享製藥產業內部人士對公司風險、對實施指導方針的猶豫以及最終需要將孕婦納入研究的看法