Pregnancy and the Pharmaceutical Industry The Movement Towards Evidence Based Pharmacotherapy for Pregnant Women 1st Edition by Kristine E. Shields 9780128190746 0128190744

Pregnancy and the Pharmaceutical Industry The Movement Towards Evidence Based Pharmacotherapy for Pregnant Women 1st Edition Kristine E. Shields – Ebook Instant Download/Delivery ISBN(s): 9780128185506, 0128185503, 9780128190746, 0128190744

Product details:

• ISBN 10: 0128190744
• ISBN 13: 9780128190746
• Author: Kristine E. Shields

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

Table contents:

I. The background, the debate, and the ethics involved

1 Drug testing and pregnant women: background and significance

2 The rationales for and against inclusion

3 The ethics involved

II. Quantitative and qualitative discoveries

4 A measure of exclusion

5 Perspectives from the industry: on exclusion

6 Perspectives from the industry: on inclusion

7 Perspectives from the industry: on litigation, regulation, incentives, and indemnity

8 Perspectives from the industry: on ethics

III. Uniting the regulators, the industry, and the advocates

9 The FDA Guidance, public comment, and affinity with industry stakeholders

10 Proposed actions for FDA and the pharmaceutical industry

11 A chance at change

12 After the guidance

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