Pregnancy and the pharmaceutical industry : the movement towards evidence-based pharmacotherapy for pregnant women
著者
書誌事項
Pregnancy and the pharmaceutical industry : the movement towards evidence-based pharmacotherapy for pregnant women
Academic Press, an imprint of Elsevier, c2019
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注記
Includes bibliographical references (p. 207-218) and index
内容説明・目次
内容説明
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.
目次
Part I. The Background, the Debate, and the Ethics Involved1. Drug Testing and Pregnant Women: Background and Significance2. The Rationales For and Against Inclusion3. The Ethics Involved
Part II. Quantitative and Qualitative Discoveries4. A Measure of Exclusion5. Perspectives from the Industry: On Exclusion6. Perspectives from the Industry: On Inclusion7. Perspectives from the Industry: On Litigation, Regulation, Incentives, and Indemnity8. Perspectives from the Industry: On Ethics
Part III. Uniting the Regulators, the Industry, and the Advocates9. The FDA Guidance, Public Comment, and Affinity with Stakeholders10. Proposed Actions for FDA and the Pharmaceutical Industry11. A Chance at Change12. After the Guidance
AppendicesFDA Guidance Document - Pregnant Women: Scientific and Ethical Consideration for Inclusion in Clinical TrialsTaskforce on Research Specific to Pregnant Women and Lactating Women: Report to the Secretary, Health and Human Services. Executive Summary
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