Target Product Profile For Drugs To Prevent Spontaneous Preterm Birth

Author : World Health Organization
Publisher : World Health Organization
Page : 20 pages
File Size : 43,9 Mb
Release : 2023-12-04
Category : Medical
ISBN : 9789240081239

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Target product profile for drugs to prevent spontaneous preterm birth by World Health Organization Pdf

Preterm birth (i.e. birth before 37 completed weeks of gestation) is the leading cause of neonatal mortality globally. There is an urgent need for new agents to prevent preterm birth, thereby reducing adverse outcomes for newborns. An initial target product profile (TPP) for drugs to prevent spontaneous preterm birth was developed and published by external parties. Following the identification of an unmet public health need, WHO has considered the already published TPP as the basis for developing a WHO TPP. The purpose of this TPP is to guide product developers and funders on the key characteristics and desired attributes of preventive agents that should be administered to pregnant women at increased risk of spontaneous preterm birth. This TPP outlines the minimal and preferred characteristics of a medicine that should: - reduce the likelihood of preterm birth and thus prevent (or mitigate) adverse newborn outcomes due to prematurity; - have an excellent safety profile during pregnancy; - be suitable for prescription or administration by skilled health personnel in any health care setting where pregnant women receive antenatal care, including in LMICs; - be commenced early in pregnancy and can be continued throughout pregnancy, as required.

Author : World Health Organization
Publisher : World Health Organization
Page : 20 pages
File Size : 47,8 Mb
Release : 2023-12-04
Category : Medical
ISBN : 9789240081253

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Target product profile for drugs to manage preterm labour by World Health Organization Pdf

Preterm birth (i.e. birth before 37 completed weeks of gestation) is the leading cause of neonatal mortality globally. Preterm newborns that survive are at an increased risk of a number of short- and long-term adverse health outcomes, including chronic lung disease, infections and neurological, visual and auditory disabilities. A number of tocolytic agents are currently in use internationally to slow down or stop the progression of labour. However, none of those has shown substantive improvements in fetal or newborn health outcomes.There is an urgent need for new agents to manage preterm birth, thereby reducing adverse outcomes for newborns. An initial target product profile (TPP) for drugs to manage preterm labour was developed and published by external parties. Following the identification of an unmet public health need, WHO has considered the already published TPP as the basis for developing a WHO TPP. The purpose of this TPP is to guide product developers and funders on the key characteristics and desired attributes of therapeutic agents for pregnant women experiencing spontaneous preterm labour.

Author : Agency for Healthcare Research and Quality/AHRQ
Publisher : Government Printing Office
Page : 396 pages
File Size : 53,6 Mb
Release : 2014-04-01
Category : Medical
ISBN : 9781587634338

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Registries for Evaluating Patient Outcomes by Agency for Healthcare Research and Quality/AHRQ Pdf

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.

Author : Institute of Medicine,Board on Health Sciences Policy,Committee on Understanding Premature Birth and Assuring Healthy Outcomes
Publisher : National Academies Press
Page : 791 pages
File Size : 54,7 Mb
Release : 2007-05-23
Category : Medical
ISBN : 9780309101592

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Preterm Birth by Institute of Medicine,Board on Health Sciences Policy,Committee on Understanding Premature Birth and Assuring Healthy Outcomes Pdf

The increasing prevalence of preterm birth in the United States is a complex public health problem that requires multifaceted solutions. Preterm birth is a cluster of problems with a set of overlapping factors of influence. Its causes may include individual-level behavioral and psychosocial factors, sociodemographic and neighborhood characteristics, environmental exposure, medical conditions, infertility treatments, and biological factors. Many of these factors co-occur, particularly in those who are socioeconomically disadvantaged or who are members of racial and ethnic minority groups. While advances in perinatal and neonatal care have improved survival for preterm infants, those infants who do survive have a greater risk than infants born at term for developmental disabilities, health problems, and poor growth. The birth of a preterm infant can also bring considerable emotional and economic costs to families and have implications for public-sector services, such as health insurance, educational, and other social support systems. Preterm Birth assesses the problem with respect to both its causes and outcomes. This book addresses the need for research involving clinical, basic, behavioral, and social science disciplines. By defining and addressing the health and economic consequences of premature birth, this book will be of particular interest to health care professionals, public health officials, policy makers, professional associations and clinical, basic, behavioral, and social science researchers.

Author : Weichung Joe Shih,Joseph Aisner
Publisher : CRC Press
Page : 320 pages
File Size : 43,5 Mb
Release : 2021-10-26
Category : Medical
ISBN : 9781000462814

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Statistical Design, Monitoring, and Analysis of Clinical Trials by Weichung Joe Shih,Joseph Aisner Pdf

Statistical Design, Monitoring, and Analysis of Clinical Trials, Second Edition concentrates on the biostatistics component of clinical trials. This new edition is updated throughout and includes five new chapters. Developed from the authors’ courses taught to public health and medical students, residents, and fellows during the past 20 years, the text shows how biostatistics in clinical trials is an integration of many fundamental scientific principles and statistical methods. The book begins with ethical and safety principles, core trial design concepts, the principles and methods of sample size and power calculation, and analysis of covariance and stratified analysis. It then focuses on sequential designs and methods for two-stage Phase II cancer trials to Phase III group sequential trials, covering monitoring safety, futility, and efficacy. The authors also discuss the development of sample size reestimation and adaptive group sequential procedures, phase 2/3 seamless design and trials with predictive biomarkers, exploit multiple testing procedures, and explain the concept of estimand, intercurrent events, and different missing data processes, and describe how to analyze incomplete data by proper multiple imputations. This text reflects the academic research, commercial development, and public health aspects of clinical trials. It gives students and practitioners a multidisciplinary understanding of the concepts and techniques involved in designing, monitoring, and analyzing various types of trials. The book’s balanced set of homework assignments and in-class exercises are appropriate for students and researchers in (bio)statistics, epidemiology, medicine, pharmacy, and public health.

Author : Mark D. Kilby,Anthony Johnson,Dick Oepkes
Publisher : Cambridge University Press
Page : 471 pages
File Size : 49,7 Mb
Release : 2013
Category : Medical
ISBN : 9781107012134

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Fetal Therapy by Mark D. Kilby,Anthony Johnson,Dick Oepkes Pdf

Covers the latest insights any fetal specialist needs and provides essential knowledge for professionals caring for women with high-risk pregnancies.

Author : Anonim
Publisher : Unknown
Page : 728 pages
File Size : 53,7 Mb
Release : 2010
Category : Government publications
ISBN : UCSD:31822037817723

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How Tobacco Smoke Causes Disease by Anonim Pdf

This report considers the biological and behavioral mechanisms that may underlie the pathogenicity of tobacco smoke. Many Surgeon General's reports have considered research findings on mechanisms in assessing the biological plausibility of associations observed in epidemiologic studies. Mechanisms of disease are important because they may provide plausibility, which is one of the guideline criteria for assessing evidence on causation. This report specifically reviews the evidence on the potential mechanisms by which smoking causes diseases and considers whether a mechanism is likely to be operative in the production of human disease by tobacco smoke. This evidence is relevant to understanding how smoking causes disease, to identifying those who may be particularly susceptible, and to assessing the potential risks of tobacco products.

Author : Jane Paul,International Labour Office
Publisher : International Labour Organization
Page : 125 pages
File Size : 51,5 Mb
Release : 2004
Category : Technology & Engineering
ISBN : 9789221152385

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Healthy Beginnings by Jane Paul,International Labour Office Pdf

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.

Author : World Health Organization
Publisher : Unknown
Page : 37 pages
File Size : 43,8 Mb
Release : 2015-04-20
Category : Medical
ISBN : 9241548738

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Guidelines for the Identification and Management of Substance Use and Substance Use Disorders in Pregnancy by World Health Organization Pdf

These guidelines have been developed to enable professionals to assist women who are pregnant, or have recently had a child, and who use alcohol or drugs or who have a substance use disorder, to achieve healthy outcomes for themselves and their fetus or infant. They have been developed in response to requests from organizations, institutions and individuals for technical guidance on the identification and management of alcohol, and other substance use and substance use disorders in pregnant women. They were developed in tandem with the WHO recommendations for the prevention and management of tobacco use and second-hand smoke exposure in pregnancy.

Author : Anonim
Publisher : World Health Organization
Page : 393 pages
File Size : 51,8 Mb
Release : 2003
Category : Childbirth
ISBN : 9789241545877

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Managing Complications in Pregnancy and Childbirth by Anonim Pdf

The emphasis of the manual is on rapid assessment and decision making. The clinical action steps are based on clinical assessment with limited reliance on laboratory or other tests and most are possible in a variety of clinical settings.

Author : National Academies of Sciences, Engineering, and Medicine,Division of Behavioral and Social Sciences and Education,Board on Children, Youth, and Families,Committee on Supporting the Parents of Young Children
Publisher : National Academies Press
Page : 525 pages
File Size : 55,6 Mb
Release : 2016-11-21
Category : Social Science
ISBN : 9780309388573

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Parenting Matters by National Academies of Sciences, Engineering, and Medicine,Division of Behavioral and Social Sciences and Education,Board on Children, Youth, and Families,Committee on Supporting the Parents of Young Children Pdf

Decades of research have demonstrated that the parent-child dyad and the environment of the familyâ€"which includes all primary caregiversâ€"are at the foundation of children's well- being and healthy development. From birth, children are learning and rely on parents and the other caregivers in their lives to protect and care for them. The impact of parents may never be greater than during the earliest years of life, when a child's brain is rapidly developing and when nearly all of her or his experiences are created and shaped by parents and the family environment. Parents help children build and refine their knowledge and skills, charting a trajectory for their health and well-being during childhood and beyond. The experience of parenting also impacts parents themselves. For instance, parenting can enrich and give focus to parents' lives; generate stress or calm; and create any number of emotions, including feelings of happiness, sadness, fulfillment, and anger. Parenting of young children today takes place in the context of significant ongoing developments. These include: a rapidly growing body of science on early childhood, increases in funding for programs and services for families, changing demographics of the U.S. population, and greater diversity of family structure. Additionally, parenting is increasingly being shaped by technology and increased access to information about parenting. Parenting Matters identifies parenting knowledge, attitudes, and practices associated with positive developmental outcomes in children ages 0-8; universal/preventive and targeted strategies used in a variety of settings that have been effective with parents of young children and that support the identified knowledge, attitudes, and practices; and barriers to and facilitators for parents' use of practices that lead to healthy child outcomes as well as their participation in effective programs and services. This report makes recommendations directed at an array of stakeholders, for promoting the wide-scale adoption of effective programs and services for parents and on areas that warrant further research to inform policy and practice. It is meant to serve as a roadmap for the future of parenting policy, research, and practice in the United States.

Author : Peter C. Rubin,Margaret Ramsey
Publisher : John Wiley & Sons
Page : 256 pages
File Size : 44,9 Mb
Release : 2008-04-30
Category : Medical
ISBN : 9780470695555

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Prescribing in Pregnancy by Peter C. Rubin,Margaret Ramsey Pdf

This thoroughly revised edition of Prescribing in Pregnancy is a practical and authoritative guide for all doctors who prescribe for pregnant women. Covering both the prescribing of drugs for common conditions in pregnant women and the effect of different drugs on pregnancy, the fourth edition now also features: strengthened evidence for the prescribing regimens updated prescribing information throughout a new user-friendly design Written by leading specialists, Prescribing in Pregnancy covers the common medical problems encountered in pregnancy, and includes information on travel medicine, breast feeding and the management of drug and alcohol abuse. The fourth edition of this comprehensive and relevant book is an invaluable reference for the busy doctor, on the wards and in general practice.

Author : Anonim
Publisher : Unknown
Page : 584 pages
File Size : 53,7 Mb
Release : 2007
Category : Lead
ISBN : UOM:39015074067839

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Toxicological Profile for Lead by Anonim Pdf

Author : Tricia E. Wright
Publisher : Unknown
Page : 155 pages
File Size : 43,5 Mb
Release : 2018-05-10
Category : Medical
ISBN : 9781108400985

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Opioid-Use Disorders in Pregnancy by Tricia E. Wright Pdf

Gain guidance and support when treating the high-risk population of women confronting (or battling) opioid-use disorders during pregnancy.

Author : World Health Organization
Publisher : World Health Organization
Page : 442 pages
File Size : 47,9 Mb
Release : 2013
Category : Medical
ISBN : 9789241548373

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Pocket Book of Hospital Care for Children by World Health Organization Pdf

The Pocket Book is for use by doctors nurses and other health workers who are responsible for the care of young children at the first level referral hospitals. This second edition is based on evidence from several WHO updated and published clinical guidelines. It is for use in both inpatient and outpatient care in small hospitals with basic laboratory facilities and essential medicines. In some settings these guidelines can be used in any facilities where sick children are admitted for inpatient care. The Pocket Book is one of a series of documents and tools that support the Integrated Managem.