Pregnancy and the Pharmaceutical Industry
  • Author : Kristine E. Shields
  • Release Date : 05 June 2019
  • Publisher : Academic Press
  • Genre : Medical
  • Pages : 244
  • ISBN 13 : 9780128190746

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Book excerpt: 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

Pregnancy and the Pharmaceutical Industry

Pregnancy and the Pharmaceutical Industry

Author : Kristine E. Shields
Publisher : Academic Press
Genre : Medical
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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 ...

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Publisher : Elsevier
Genre : Medical
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Author : Christof Schaefer,Paul W.J. Peters,Richard K Miller
Publisher : Academic Press
Genre : Medical
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Drugs During Pregnancy and Lactation, 3rd Edition is a quick and reliable reference for all those working in disciplines related to fertility, pregnancy, lactation, child health and human genetics who prescribe or deliver medicinal products, and to those who evaluate health and safety risks. Each chapter contains twofold information regarding ...

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Publisher : Government Printing Office
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Publisher : Penguin
Genre : Health & Fitness
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Author : National Academies of Sciences, Engineering, and Medicine,Health and Medicine Division,Board on Health Sciences Policy,Committee on Pain Management and Regulatory Strategies to Address Prescription Opioid Abuse
Publisher : National Academies Press
Genre : Medical
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Author : Institute of Medicine,Committee on Ethical and Legal Issues Relating to the Inclusion of Women in Clinical Studies
Publisher : National Academies Press
Genre : Medical
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Publisher : Unknown
Genre : Health & Fitness
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