Pregnancy and the Pharmaceutical Industry

Pregnancy and the Pharmaceutical Industry
Author: Kristine E. Shields
Publsiher: Academic Press
Total Pages: 244
Release: 2019-06-05
Genre: Medical
ISBN: 9780128190746

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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 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

Improved Drug Therapy in Pregnancy and in Neonatology

Improved Drug Therapy in Pregnancy and in Neonatology
Author: Pharmaceutical Manufacturers Association of Canada. Medical Research and Development Section
Publsiher: Unknown
Total Pages: 135
Release: 2022
Genre: Electronic Book
ISBN: OCLC:497449540

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Registries for Evaluating Patient Outcomes

Registries for Evaluating Patient Outcomes
Author: Agency for Healthcare Research and Quality/AHRQ
Publsiher: Government Printing Office
Total Pages: 356
Release: 2014-04-01
Genre: Medical
ISBN: 9781587634338

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This User’s Guide is intended to support the design, implementation, analysis, interpretation, and quality evaluation of registries created to increase understanding of patient outcomes. For the purposes of this guide, a patient registry is an organized system that uses observational study methods to collect uniform data (clinical and other) to evaluate specified outcomes for a population defined by a particular disease, condition, or exposure, and that serves one or more predetermined scientific, clinical, or policy purposes. A registry database is a file (or files) derived from the registry. Although registries can serve many purposes, this guide focuses on registries created for one or more of the following purposes: to describe the natural history of disease, to determine clinical effectiveness or cost-effectiveness of health care products and services, to measure or monitor safety and harm, and/or to measure quality of care. Registries are classified according to how their populations are defined. For example, product registries include patients who have been exposed to biopharmaceutical products or medical devices. Health services registries consist of patients who have had a common procedure, clinical encounter, or hospitalization. Disease or condition registries are defined by patients having the same diagnosis, such as cystic fibrosis or heart failure. The User’s Guide was created by researchers affiliated with AHRQ’s Effective Health Care Program, particularly those who participated in AHRQ’s DEcIDE (Developing Evidence to Inform Decisions About Effectiveness) program. Chapters were subject to multiple internal and external independent reviews.

Drugs During Pregnancy and Lactation

Drugs During Pregnancy and Lactation
Author: Christof Schaefer,Paul W.J. Peters,Richard K Miller
Publsiher: Academic Press
Total Pages: 918
Release: 2014-09-17
Genre: Medical
ISBN: 9780124079014

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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 drugs that are appropriate for prescription during pregnancy and an assessment of the risk of a drug when exposure during pregnancy has already occurred. Thoroughly updated with current regulations, references to the latest pharmacological data, and new medicinal products, this edition is a comprehensive resource covering latest knowledge and findings related to drugs during lactation and pregnancy. Provides evidence-based recommendations to help clinicians make appropriate recommendations Uniquely organized and structured according to drug class and treatment indications to offer authoritative clinical content on potential adverse effects Highlights new research developments from primary source about working mechanism of substances that cause developmental disorders

Trusted Advice Your Healthy Pregnancy

Trusted Advice Your Healthy Pregnancy
Author: Miriam Stoppard
Publsiher: Penguin
Total Pages: 80
Release: 2010-12-20
Genre: Health & Fitness
ISBN: 9780756673857

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Your Healthy Pregnancy focuses on how to care for baby, body, and mind during pregnancy, with advice on diet, exercise, and preparing emotionally for parenthood. Miriam's reassuring advice covers every aspect of physical and mental wellbeing during pregnancy, from keeping fit to stylish maternity wear, working during pregnancy, and how to maintain a sensual relationship for as long as possible.

Drugs in Pregnancy Paediatrics and Geriatrics

Drugs in Pregnancy  Paediatrics and Geriatrics
Author: A. M. Edwards
Publsiher: Unknown
Total Pages: 135
Release: 1981
Genre: Electronic Book
ISBN: OCLC:28837551

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Transparency Power and Influence in the Pharmaceutical Industry

Transparency  Power  and Influence in the Pharmaceutical Industry
Author: Katherine Fierlbeck,Janice Graham,Matthew Herder
Publsiher: University of Toronto Press
Total Pages: 304
Release: 2021-06-14
Genre: Pharmaceutical policy
ISBN: 9781487529048

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Transparency, Power, and Influence in the Pharmaceutical Industry evaluates the progress made in holding the pharmaceutical industry to account through greater transparency.

Pain Management and the Opioid Epidemic

Pain Management and the Opioid Epidemic
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
Publsiher: National Academies Press
Total Pages: 482
Release: 2017-09-28
Genre: Medical
ISBN: 9780309459570

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Drug overdose, driven largely by overdose related to the use of opioids, is now the leading cause of unintentional injury death in the United States. The ongoing opioid crisis lies at the intersection of two public health challenges: reducing the burden of suffering from pain and containing the rising toll of the harms that can arise from the use of opioid medications. Chronic pain and opioid use disorder both represent complex human conditions affecting millions of Americans and causing untold disability and loss of function. In the context of the growing opioid problem, the U.S. Food and Drug Administration (FDA) launched an Opioids Action Plan in early 2016. As part of this plan, the FDA asked the National Academies of Sciences, Engineering, and Medicine to convene a committee to update the state of the science on pain research, care, and education and to identify actions the FDA and others can take to respond to the opioid epidemic, with a particular focus on informing FDA's development of a formal method for incorporating individual and societal considerations into its risk-benefit framework for opioid approval and monitoring.

New Pregnancy and Birth

New Pregnancy and Birth
Author: Miriam Stoppard
Publsiher: Dorling Kindersley Ltd
Total Pages: 256
Release: 2009-01-02
Genre: Health & Fitness
ISBN: 9781405339568

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Updated, trusted advice for parents-to-be from expert Dr Miriam Stoppard From Britain's most trusted pregnancy and babycare expert Dr Miriam Stoppard, a guide to every magical stage of your pregnancy, from pre-conception planning to the first days of life. Packed with reassuring, fully updated advice on fertility treatment, antenatal care, nutrition, exercise and your choices in childbirth and special sections on working mothers and expectant fathers - keep it close so there's always somewhere to turn if you have a question. A month-by-month pregnancy calendar showing your baby's development in the womb means you'll know what's happening when. Perfect for knowing what you will go through at every stage.

Bonding Before Birth

Bonding Before Birth
Author: Miriam Stoppard
Publsiher: Penguin
Total Pages: 192
Release: 2008-04-21
Genre: Health & Fitness
ISBN: 9780756643294

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Bonding Before Birth combines up-to-the-minute research with enlightened and compassionate wisdom. This book explores what science knows about babies in the womb and explains why mother-baby bonding is so vital for the future well-being of mother, father, and baby. Dr. Miriam Stoppard writes about the feelings that expectant parents experience during the first, second and third trimesters and promotes the significance of rites of passage through pregnancy, from adjusting to the changes that parenthood brings to celebrating your future as a family. The emotional and psychological elements of pregnancy are often overlooked in favor of hard facts and scientific evidence. This book redresses the balance and turns its attention to the conflicting feelings of exhilaration and anxiety, dreams and fears that so often characterize the nine months of pregnancy and gives parents-to-be inspiring guidance through these uncharted waters.

Conception Pregnancy and Birth

Conception  Pregnancy and Birth
Author: Miriam Stoppard
Publsiher: DK Publishing (Dorling Kindersley)
Total Pages: 376
Release: 2008
Genre: Childbirth
ISBN: 1405329726

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New edition of the UK's bestselling pregnancy guide, from expert Dr Miriam StoppardIf you're pregnant and want trusted advice, have all your questions answered by top parenting expert Dr Miriam Stoppard - Britain's most popular and trusted childbirth specialist. From a month-by-month development guide, to the latest on fertility, antenatal testing, diagnostic procedure, labour choices and caring for your newborn; reassuring, practical advice on all aspects of your antenatal care will help you every step of the way. Plus, find trusted advice for dads-to-be plus helpful case studies which look at a range of issues from infertility to caring for premature babies.

Women and Health Research

Women and Health Research
Author: Institute of Medicine,Committee on Ethical and Legal Issues Relating to the Inclusion of Women in Clinical Studies
Publsiher: National Academies Press
Total Pages: 288
Release: 1994-02-01
Genre: Medical
ISBN: 9780309049924

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In the nineteenth century some scientists argued that women should not be educated because thinking would use energy needed by the uterus for reproduction. The proof? Educated women had a lower birth rate. Today's researchers can only shake their heads at such reasoning. Yet professional journals and the popular press are increasingly criticizing medical research for ignoring women's health issues. Women and Health Research examines the facts behind the public's perceptions about women participating as subjects in medical research. With the goal of increasing researchers' awareness of this important topic, the book explores issues related to maintaining justice (in its ethical sense) in clinical studies. Leading experts present general principles for the ethical conduct of research on women--principles that are especially important in the light of recent changes in federal policy on the inclusion of women in clinical research. Women and Health Research documents the historical shift from a paternalistic approach by researchers toward women and a disproportionate reliance on certain groups for research to one that emphasizes proper access for women as subjects in clinical studies in order to ensure that women receive the benefits of research. The book addresses present-day challenges to equity in four areas: Scientific--Do practical aspects of scientific research work at cross-purposes to gender equity? Focusing on drug trials, the authors identify rationales for excluding people from research based on demographics. Social and Ethical--The authors offer compelling discussions on subjectivity in science, the evidence for male bias, and issues related to race and ethnicity, as well as the recruitment, retention, and protection of research participants. Legal--Women and Health Research reviews federal research policies that affect the inclusion of women and evaluates the basis for researchers' fears about liability, citing court cases. Risk--The authors focus on risks to reproduction and offspring in clinical drug trials, exploring how risks can be identified for study participants, who should make the assessment of risk and benefit for participation in a clinical study, and how legal implications could be addressed. This landmark study will be of immediate use to the research community, policymakers, women's health advocates, attorneys, and individuals.

First Time Parents

First Time Parents
Author: Miriam Stoppard
Publsiher: Penguin
Total Pages: 192
Release: 2009-03-02
Genre: Family & Relationships
ISBN: 9780756663445

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First-time Parents is an updated and redesigned edition of a practical guide to parenting that focuses especially on first-time parents. There is advice on pregnancy and birth; day-to-day babycare – feeding, washing and dressing; as well as guidance on the longer-term emotional issues of adapting to becoming a family. The book also addresses all other issues such as maintaining your relationship and going back to work. There are special panels that give, not only the mother’s, but also the father’s, points of view on a variety ofissues to help both parents understand the other’s needs. In this easy-to-read guide, Miriam Stoppard gives new mothers and fathers the confidence to fashion their own brand of family life.

Pregnancy

Pregnancy
Author: Benjamin Ogbonna
Publsiher: Unknown
Total Pages: 144
Release: 2007
Genre: Health & Fitness
ISBN: 1434346420

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Pregnancy is an event in a woman's life that calls for joy and happiness. This is in anticipation of the birth of a new baby into the world. It is usually an uneventful experience especially in the western world and where problems arise, help is always available. Not so in the Sub-Saharan African region where pregnancy is a source of sorrow and pain for the vast majority of women. Certainly not in a situation where 1 out of 16 pregnant women dies as a result of complications of pregnancy. This book brings to the front burner the issue of maternal deaths in Sub-Saharan Africa. It should make an interesting reading for people in the western world to enable them to fully appreciate what is happening in other places. It is a book that bares it all; more like washing your dirty linen in the public. For people in Sub-Saharan Africa, it is a book that is intended to rouse them from their protracted slumber to enable them appreciate that there is a problem that needs urgent attention. The various causes of maternal deaths are discussed in details and solutions are proffered were necessary to help the people that are directly involved. The book also acknowledges the efforts of charitable organizations around the world that have been actively involved towards reducing the deaths that occur in pregnancy in the region. More help is however needed from Pharmaceutical Companies towards the provision of cheap retroviral drugs to fight the ravages of HIV infection in the region. This book is written in a language that has reduced to the barest minimum medical terminologies for easy readership by the general public.

Mindbend

Mindbend
Author: Robin Cook
Publsiher: Penguin
Total Pages: 352
Release: 1986-01-02
Genre: Fiction
ISBN: 9781101209011

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Future doctor Adam Schonberg loved his wife. That was why he took a job with the giant drug firm Arolen, for the money he needed for their coming baby. His wife, Jennifer, felt she would get the best of care at the Julian Clinic as her pregnancy progressed. It seemed a happy coincidence that the Julian Clinic was owned by Arolen...until Adam Schonberg slowly began to suspect the terrifying truth about this connection...and about the hideous evil perpetrated on the wife he loved by the doctor she helplessly trusted...