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Pregnancy And The Pharmaceutical Industry
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Book Synopsis Pregnancy and the Pharmaceutical Industry by : Kristine E. Shields
Download or read book Pregnancy and the Pharmaceutical Industry written by Kristine E. Shields and published by Academic Press. This book was released on 2019-05-24 with total page 247 pages. Available in PDF, EPUB and Kindle. 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
Author :Agency for Healthcare Research and Quality/AHRQ Publisher :Government Printing Office ISBN 13 :1587634333 Total Pages :385 pages Book Rating :4.5/5 (876 download)
Book Synopsis Registries for Evaluating Patient Outcomes by : Agency for Healthcare Research and Quality/AHRQ
Download or read book Registries for Evaluating Patient Outcomes written by Agency for Healthcare Research and Quality/AHRQ and published by Government Printing Office. This book was released on 2014-04-01 with total page 385 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Book Synopsis Adverse Effects by : Kathleen McDonnell
Download or read book Adverse Effects written by Kathleen McDonnell and published by . This book was released on 1986 with total page 264 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Author :Pharmaceutical Manufacturers Association of Canada. Medical Research and Development Section Publisher : ISBN 13 : Total Pages : pages Book Rating :4.:/5 (497 download)
Book Synopsis Improved Drug Therapy in Pregnancy and in Neonatology by : Pharmaceutical Manufacturers Association of Canada. Medical Research and Development Section
Download or read book Improved Drug Therapy in Pregnancy and in Neonatology written by Pharmaceutical Manufacturers Association of Canada. Medical Research and Development Section and published by . This book was released on with total page pages. Available in PDF, EPUB and Kindle. Book excerpt:
Book Synopsis Pregnancy as a Disease by : Donald H. Merkin
Download or read book Pregnancy as a Disease written by Donald H. Merkin and published by Port Washington, N.Y. : Kennikat Press. This book was released on 1976 with total page 164 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Book Synopsis Clinical Pharmacology During Pregnancy by : Donald Mattison
Download or read book Clinical Pharmacology During Pregnancy written by Donald Mattison and published by Academic Press. This book was released on 2012-12-05 with total page 496 pages. Available in PDF, EPUB and Kindle. Book excerpt: Clinical Pharmacology During Pregnancy is written for clinicians, physicians, midwives, nurses, pharmacists and other medical professionals directly involved in the care of women during pregnancy. This book focuses on the impact of pregnancy on drug disposition and also includes coverage of treatments for diseases of specific body systems, as well as essential content on dosing and efficacy. Written in a clear and practical manner, this reference provides easily accessible information and clinical guidance on how best to treat women with medications during pregnancy.
Book Synopsis Drugs During Pregnancy and Lactation by : Christof Schaefer
Download or read book Drugs During Pregnancy and Lactation written by Christof Schaefer and published by Academic Press. This book was released on 2014-09-17 with total page 920 pages. Available in PDF, EPUB and Kindle. Book excerpt: Drugs During Pregnancy and Lactation, Third 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
Book Synopsis Drugs in Pregnancy by : Radhwan Nidal Al-Zidan
Download or read book Drugs in Pregnancy written by Radhwan Nidal Al-Zidan and published by CRC Press. This book was released on 2020-06-09 with total page 436 pages. Available in PDF, EPUB and Kindle. Book excerpt: This first-of-its-kind handbook offers crucial information on the safety of drugs taken during pregnancy. It covers an exhaustive list of common and less common drugs and provides for each drug the FDA letter categorization and newly approved “Pregnancy and Lactation Labeling Rule (PLLR)” systems for rating drug risks in pregnancy, imposed by the U.S. Food and Drug Administration (FDA). Drugs in Pregnancy: A Handbook for Pharmacists and Physicians covers the pregnancy ramifications of using anti-infective, cardiovascular, hematologic, dermatologic drugs and drugs affecting the endocrine, central, autonomic, gastrointestinal, musculoskeletal systems in addition to herbs, vitamins and dietary supplements. To enable the reader to develop well-informed knowledge about a drug safety profile during pregnancy, three sections of data have been provided for each drug: FDA Category, Risk Summary, and Further Reading.
Book Synopsis Drug Use in Pregnancy by : Jennifer R. Niebyl
Download or read book Drug Use in Pregnancy written by Jennifer R. Niebyl and published by . This book was released on 1988 with total page 264 pages. Available in PDF, EPUB and Kindle. Book excerpt: Abstract: This book addresses the use of drug groups for various clinical indications during pregnancy. In general, non-pharmacologic remedies are recommended if these will suffice before drug therapy is instituted. Known adverse effects of drugs are documented and caution is advised because of the many unknowns about long-term effects of drug exposure to the developing fetus. Drugs used for the common cold, antituberculosis agents, antihypertensives, anticonvulsants, and marijuana and cocaine are included.
Author :National Academies of Sciences, Engineering, and Medicine Publisher :National Academies Press ISBN 13 :0309669820 Total Pages :369 pages Book Rating :4.3/5 (96 download)
Book Synopsis Birth Settings in America by : National Academies of Sciences, Engineering, and Medicine
Download or read book Birth Settings in America written by National Academies of Sciences, Engineering, and Medicine and published by National Academies Press. This book was released on 2020-05-01 with total page 369 pages. Available in PDF, EPUB and Kindle. Book excerpt: The delivery of high quality and equitable care for both mothers and newborns is complex and requires efforts across many sectors. The United States spends more on childbirth than any other country in the world, yet outcomes are worse than other high-resource countries, and even worse for Black and Native American women. There are a variety of factors that influence childbirth, including social determinants such as income, educational levels, access to care, financing, transportation, structural racism and geographic variability in birth settings. It is important to reevaluate the United States' approach to maternal and newborn care through the lens of these factors across multiple disciplines. Birth Settings in America: Outcomes, Quality, Access, and Choice reviews and evaluates maternal and newborn care in the United States, the epidemiology of social and clinical risks in pregnancy and childbirth, birth settings research, and access to and choice of birth settings.
Book Synopsis Clinical Research Involving Pregnant Women by : Françoise Baylis
Download or read book Clinical Research Involving Pregnant Women written by Françoise Baylis and published by Springer. This book was released on 2017-01-02 with total page 306 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book discusses ‘how’ to respectfully and responsibly include pregnant women in clinical research. In sharp contrast, the existing literature predominantly focuses on the reasons ‘why’ the inclusion of pregnant women in clinical research is necessary – viz., to develop effective treatments for women during pregnancy, to promote fetal safety, to reduce harm to women and fetuses from suboptimal care, and to allow access to the benefits of research participation. This book supports the shift to a new default position, whereby pregnant women are included in clinical research unless researchers argue convincingly for their exclusion. This shift raises many as yet unexplored ethical and policy questions about existing barriers to the equitable inclusion of pregnant women in research. This book is original in three key ways. First, it presents an unparalleled depth of analysis of the ethics of research with pregnant women, bringing together many of the key authors in this field as well as experts in research ethics and in vulnerability who have not previously applied their work to pregnant women. Second, it includes innovative theoretical work in ethics and disease specific case studies that highlight the current complexity and future challenges of research involving pregnant women. Third, the book brings together authors who argue both for and against including more pregnant women in formal clinical trials.
Book Synopsis Women and Health Research by : Institute of Medicine
Download or read book Women and Health Research written by Institute of Medicine and published by National Academies Press. This book was released on 1994-02-01 with total page 286 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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 womenâ€"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: Scientificâ€"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 Ethicalâ€"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. Legalâ€"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. Riskâ€"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.
Book Synopsis Drugs in Pregnancy and Lactation by : Gerald G. Briggs
Download or read book Drugs in Pregnancy and Lactation written by Gerald G. Briggs and published by Lippincott Williams & Wilkins. This book was released on 2012-03-28 with total page 1728 pages. Available in PDF, EPUB and Kindle. Book excerpt: An A-Z listing of drugs by generic name. Each monograph summarizes the known and/or possible effects of the drug on the fetus. It also summarizes the known/possible passage of the drug into the human breast milk. A careful and exhaustive summarization of the world literature as it relates to drugs in pregnancy and lacation. Each monograph contains six parts: generic US name, Pharmacologic class, Risk factor, Fetal risk summary, Breast feeding summary, References
Book Synopsis Drug Safety in Pregnancy by : Peter I. Folb
Download or read book Drug Safety in Pregnancy written by Peter I. Folb and published by Elsevier Publishing Company. This book was released on 1990 with total page 552 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book combines the perspectives of clinical and laboratory medicine so as to present critically considered and practical information to the clinician concerning drug-induced injury to the human embryo and fetus. The information that has been included has been thoroughly and independently evaluated by the authors at source. Animal and pharmacokinetic data have been used when their relevance to the human situation is direct, or where they demonstrate important principles. Classical teratology syndromes, such as those caused by thalidomide or diethystilboestrol have been examined in some detail, even though the use of these agents in pregnancy no longer reflects contemporary practice. This has been done because they add an understanding of clinical teratology. Drug Safety in Pregnancy can be regarded as a companion book to Meyler's Side Effects of Drugs, and to the Side Effects of Drugs Annuals, and care has been taken to include material contained in recent editions of those volumes. The book provides a comprehensive and critical data base for any clinician, pharmacologist or research worker concerned with the safe use of medicines in the pregnant woman.
Download or read book Healthy Beginnings written by Jane Paul and published by International Labour Organization. This book was released on 2004 with total page 125 pages. Available in PDF, EPUB and Kindle. Book excerpt: Improving maternal health and reducing child mortality are among the eight UN Millennium Development Goals. This publication contains guidance on maternity protection in the workplace, focusing on measures that can be taken to establish a decent workplace and to identify workplace risks. The starting point is the Maternity Protection Convention (No. 183), adopted by the International Labour Conference in 2000 and its accompanying Recommendation (No. 191). The guide is intended for general use as a reference tool for employers, workers, trade union leaders, occupation health and safety advisors, labour inspectors and others involved in workplace health and maternity protection.
Book Synopsis Thalidomide and the Power of the Drug Companies by : Henning Sjöström
Download or read book Thalidomide and the Power of the Drug Companies written by Henning Sjöström and published by . This book was released on 1972 with total page 294 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Book Synopsis Drugs in Pregnancy, Paediatrics and Geriatrics by : A. M. Edwards
Download or read book Drugs in Pregnancy, Paediatrics and Geriatrics written by A. M. Edwards and published by . This book was released on 1981 with total page pages. Available in PDF, EPUB and Kindle. Book excerpt:
