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Pregnancy and the pharmaceutical ind...

Shields, Kristine E.,

Pregnancy and the pharmaceutical industrythe movement towards evidence-based pharmacotherapy for pregnant women /

Record Type:	Electronic resources : Monograph/item
Title/Author:	Pregnancy and the pharmaceutical industryKristine E. Shields
Reminder of title:	the movement towards evidence-based pharmacotherapy for pregnant women /
Author:	Shields, Kristine E.,
Published:	London :Academic Press,2019.
Description:	1 online resource :ill.
Subject:	Obstetrical pharmacology.
Online resource:	https://www.sciencedirect.com/science/book/9780128185506
ISBN:	9780128190746 (electronic bk.)

Pregnancy and the pharmaceutical industrythe movement towards evidence-based pharmacotherapy for pregnant women /
Shields, Kristine E.,

Pregnancy and the pharmaceutical industrythe movement towards evidence-based pharmacotherapy for pregnant women /[electronic resource] :Kristine E. Shields - London :Academic Press,2019. - 1 online resource :ill.

Includes bibliographical references and index

Front Cover; Pregnancy and the Pharmaceutical Industry; Copyright Page; Dedication; Contents; List of figures; List of tables; Preface; Epigraph; List of abbreviations; I. The background, the debate, and the ethics involved; 1 Drug testing and pregnant women: background and significance; Background of the issue; Historical perspective; Proponents of inclusion; Significance of the issue; Ethical concerns; Aims of the book; Notes; 2 The rationales for and against inclusion; Rationales against the inclusion of pregnant women in clinical research

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.

ISBN: 9780128190746 (electronic bk.)Subjects--Topical Terms:

458854
Obstetrical pharmacology.
Index Terms--Genre/Form:

214472
Electronic books.

LC Class. No.: RG528

Dewey Class. No.: 618.2061

National Library of Medicine Call No.: W 20.55.H9

Pregnancy and the pharmaceutical industrythe movement towards evidence-based pharmacotherapy for pregnant women /
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100 1 $a Shields, Kristine E., $e author. $3 897216
245 1 0 $a Pregnancy and the pharmaceutical industry $h [electronic resource] : $b the movement towards evidence-based pharmacotherapy for pregnant women / $c Kristine E. Shields
260 $a London : $b Academic Press, $c 2019.
300 $a 1 online resource : $b ill.
504 $a Includes bibliographical references and index
505 0 $a Front Cover; Pregnancy and the Pharmaceutical Industry; Copyright Page; Dedication; Contents; List of figures; List of tables; Preface; Epigraph; List of abbreviations; I. The background, the debate, and the ethics involved; 1 Drug testing and pregnant women: background and significance; Background of the issue; Historical perspective; Proponents of inclusion; Significance of the issue; Ethical concerns; Aims of the book; Notes; 2 The rationales for and against inclusion; Rationales against the inclusion of pregnant women in clinical research
505 8 $a Rationale 1: the uncertain effect of new drugs on the mother and/or the fetus6Ethical rationale: nonmaleficence; Rationale 2: litigation risk-because birth defects are not uncommon, they may occur unrelated to experimental drug exposure ... ; Ethical rationale: financial stewardship; Rationale 3: the number of pregnant women needed to participate in the study in order to show efficacy may be unachievable; Ethical rationale: nonmaleficence; Rationale 4: safer study designs are available; Ethical rationale: beneficence; Rationale 5: alternative treatments are often available
505 8 $a Ethical rationale: beneficenceRationale 6: little return on investment; Ethical rationale: financial stewardship; Rationale 7: regulations do not require inclusion; Ethical rationale: financial stewardship; Rationales for the inclusion of pregnant women in clinical trials; Rationale 1: to acquire knowledge that improves the medical treatment of pregnant women and their offspring; Ethical rationale: beneficence, nonmaleficence; Rationale 2: to improve birth outcomes; Ethical rationale: beneficence, nonmaleficence
505 8 $a Rationale 3: to improve pregnant women's access to the benefits of clinical researchEthical rationale: justice; Rationale 4: to improve the ethical acquisition of information about exposed pregnancies; Ethical rationale: nonmaleficence, autonomy; Rationale 5: regulations do not require the exclusion of pregnant women; Ethical rationale: justice; Rationale 6: excluding pregnant women from participating in medical research is unethical and illegal-and may increase liti ... ; Ethical rationale: justice; Rationale 7: to follow the advice of experts in the field of women's health, law, and ethics
505 8 $a Ethical rationale: justice, nonmaleficenceNotes; 3 The ethics involved; Theoretical approaches; Principle-based ethics; The principle of respect for autonomy or respect for persons; The principles of nonmaleficence, beneficence, andthe double effect; The principle of justice; Consequentialism; Feminist ethical theory; Business ethics; Special considerations for pregnancy/maternal-fetal ethics; Application of an ethical framework for studies with pregnant women; Notes;II. Quantitative and qualitative discoveries; 4 A measure of exclusion; The US clinical trial system
520 $a 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.
650 0 $a Obstetrical pharmacology. $3 458854
650 0 $a Pregnant women $x Drug use. $3 504674
650 1 2 $a Pregnant Women. $3 897217
650 1 2 $a Research Subjects. $3 720404
650 2 2 $a Clinical Trials as Topic $x ethics. $3 897218
650 2 2 $a Clinical Trials as Topic $x legislation & jurisprudence. $3 610781
650 2 2 $a Drug Evaluation $x methods. $3 214857
650 7 $a MEDICAL $x Gynecology & Obstetrics. $2 bisacsh $3 897219
655 4 $a Electronic books. $2 local. $3 214472
856 4 0 $u https://www.sciencedirect.com/science/book/9780128185506