Download or read book Target product profile for drugs to manage preterm labour written by World Health Organization and published by World Health Organization. This book was released on 2023-12-04 with total page 20 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Download or read book Target product profile for drugs to prevent spontaneous preterm birth written by World Health Organization and published by World Health Organization. This book was released on 2023-12-04 with total page 20 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Download or read book Target product profile for drugs to treat pre eclampsia written by World Health Organization and published by World Health Organization. This book was released on 2023-11-23 with total page 24 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Pharmaceutical Medicine and Translational Clinical Research written by Divya Vohora and published by Academic Press. This book was released on 2017-11-14 with total page 527 pages. Available in PDF, EPUB and Kindle. Book excerpt: Pharmaceutical Medicine and Translational Clinical Research covers clinical testing of medicines and the translation of pharmaceutical drug research into new medicines, also focusing on the need to understand the safety profile of medicine and the benefit-risk balance. Pharmacoeconomics and the social impact of healthcare on patients and public health are also featured. It is written in a clear and straightforward manner to enable rapid review and assimilation of complex information and contains reader-friendly features.As a greater understanding of these aspects is critical for students in the areas of pharmaceutical medicine, clinical research, pharmacology and pharmacy, as well as professionals working in the pharmaceutical industry, this book is an ideal resource. Includes detailed coverage of current trends and key topics in pharmaceutical medicine, including biosimilars, biobetters, super generics, and Provides a comprehensive look at current and important aspects of the science and regulation of drug and biologics discovery
Download or read book Target product profile for drugs to prevent pre eclampsia written by World Health Organization and published by World Health Organization. This book was released on 2023-11-23 with total page 20 pages. Available in PDF, EPUB and Kindle. Book excerpt: TPP for drugs to prevent pre-eclampsia Pre-eclampsia and eclampsia affect 4.6% and 1.4% of pregnant women, respectively. They account for the majority of maternal deaths and stillbirths due to hypertensive disorders of pregnancy. Pre-eclampsia can also negatively affect fetal growth, and increase the risk of preterm birth and fetal death. There is an urgent need to identify new agents to prevent pre-eclampsia. An initial target product profile (TPP) for drugs to prevent pre-eclampsia 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. This WHO TPP describes the key characteristics and desired attributes of preventive agents that should be administered to pregnant women identified as being at increased risk of developing pre-eclampsia, accompanied by monitoring for the development of pre-eclampsia. This TPP outlines minimal and preferred characteristics of a medicine that should: - prevent the development of pre- eclampsia; - have a good safety profile during pregnancy; - be commenced early in pregnancy (before 20 weeks’ gestation) and continued throughout pregnancy and postpartum as required; - be suitable for administration in any health care setting where pregnant women receive antenatal care, including in LMICs.
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 396 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.
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.
Download or read book Preterm Birth written by Institute of Medicine and published by National Academies Press. This book was released on 2007-05-23 with total page 791 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Download or read book Emerging Drug Delivery and Biomedical Engineering Technologies written by Dimitrios Lamprou and published by CRC Press. This book was released on 2023-04-06 with total page 269 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book details the advances in drug discovery and delivery and the present need for emerging technologies. Throughout the text new micro and nanofabrication techniques are described, including methods such as electrohydrodynamic processes, additive manufacturing, and microfluidics, which have the potential to produce drug delivery systems that were not possible a few years ago. This book is of great use to both entry-level and experienced researchers in the field of emerging technologies for the manufacturing of drug delivery devices. Features: Describes technologies that are significantly enhancing the delivery of drugs and biologics Presents new data on mobile and wearable point-of-care testing systems Features hot topics such as electrospinning, 3D printing and micro-needles Focuses on additive manufacturing (AM) which can be used to provide customized treatment for patients Will appeal to experienced researchers and those considering entering the field of emerging technologies for the manufacturing of drug delivery devises
Download or read book Pulmonary Drug Delivery written by Ali Nokhodchi and published by John Wiley & Sons. This book was released on 2015-06-01 with total page 392 pages. Available in PDF, EPUB and Kindle. Book excerpt: Drug therapy via inhalation route is at the cutting edge of modern drug delivery research. There has been significant progress on the understanding of drug therapy via inhalation products. However, there are still problems associated with their formulation design, including the interaction between the active pharmaceutical ingredient(s) (APIs), excipients and devices. This book seeks to cover some of the most pertinent issues and challenges of such formulation design associated with industrial production and desirable clinical outcome. The chapter topics have been selected with a view to integrating the factors that require consideration in the selection and design of device and formulation components which impact upon patient usability and clinical effectiveness. The challenges involved with the delivery of macromolecules by inhalation to both adult and pediatric patients are also covered. Written by leading international experts from both academia and industry, the book will help readers (formulation design scientists, researchers and post-graduate and specialized undergraduate students) develop a deep understanding of key aspects of inhalation formulations as well as detail ongoing challenges and advances associated with their development.
Download or read book Stem Cells in Regenerative Medicine written by Alain A. Vertes and published by John Wiley & Sons. This book was released on 2015-12-02 with total page 788 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book is a unique guide to emerging stem cell technologies and the opportunities for their commercialisation. It provides in-depth analyses of the science, business, legal, and financing fundamentals of stem cell technologies, offering a holistic assessment of this emerging and dynamic segment of the field of regenerative medicine. • Reviews the very latest advances in the technology and business of stem cells used for therapy, research, and diagnostics • Identifies key challenges to the commercialisation of stem cell technology and avenues to overcome problems in the pipeline • Written by an expert team with extensive experience in the business, basic and applied science of stem cell research This comprehensive volume is essential reading for researchers in cell biology, biotechnology, regenerative medicine, and tissue engineering, including scientists and professionals, looking to enter commercial biotechnology fields.
Download or read book Liquid Chromatography written by Salvatore Fanali and published by Elsevier. This book was released on 2023-04-20 with total page 1086 pages. Available in PDF, EPUB and Kindle. Book excerpt: Liquid Chromatography: Applications, Third Edition delivers a single source of authoritative information on all aspects of the practice of modern liquid chromatography. The text gives those working in academia and industry the opportunity to learn, refresh, and deepen their understanding of the field by covering basic and advanced theoretical concepts, recognition mechanisms, conventional and advanced instrumentation, method development, data analysis, and more. This third edition addresses new developments in the field with updated chapters from expert researchers. The book is a valuable reference for research scientists, teachers, university students, industry professionals in research and development, and quality control managers. Emphasizes the integration of chromatographic methods and sample preparation Provides important data related to complex matrices, sample preparation, and data handling Covers the most interesting and valuable applications in different fields, e.g., proteomic, metabolomics, foodomics, pollutants and contaminants, and drug analysis (forensic, toxicological, pharmaceutical, biomedical) Offers comprehensive updates to all chapters Adds new chapters on selection of liquid chromatographic mode, proteomics, doping analysis, analysis of microplastics, and analysis of pharmaceutically and biologically relevant isoforms
Download or read book The Combination Products Handbook written by Susan Neadle and published by CRC Press. This book was released on 2023-05-16 with total page 439 pages. Available in PDF, EPUB and Kindle. Book excerpt: Combination products are therapeutic and diagnostic products that combine drugs, devices, and/or biological products. According to the US Food and Drug Administration (FDA), “a combination product is one composed of any combination of a drug and a device; a biological product and a device; a drug and a biological product; or a drug, device and a biological product.” Examples include prefilled syringes, pen injectors, autoinjectors, inhalers, transdermal delivery systems, drug-eluting stents, and kits containing drug administration devices co-packaged with drugs and/or biological products. This handbook provides the most up-to-date information on the development of combination products, from the technology involved to successful delivery to market. The authors present important and up-to-the-minute pre- and post-market reviews of international combination product regulations, guidance, considerations, and best practices. This handbook: Brings clarity of understanding for global combination products guidance and regulations Reviews the current state-of-the-art considerations and best practices spanning the combination product lifecycle, pre-market through post-market Reviews medical product classification and assignment issues faced by global regulatory authorities and industry The editor is a recognized international Combination Products and Medical Device expert with over 35 years of industry experience and has an outstanding team of contributors. Endorsed by AAMI – Association for the Advancement of Medical Instrumentation.
Download or read book Formulation and Process Development Strategies for Manufacturing Biopharmaceuticals written by Feroz Jameel and published by John Wiley & Sons. This book was released on 2010-07-13 with total page 986 pages. Available in PDF, EPUB and Kindle. Book excerpt: A real-world guide to the production and manufacturing of biopharmaceuticals While much has been written about the science of biopharmaceuticals, there is a need for practical, up-to-date information on key issues at all stages of developing and manufacturing commercially viable biopharmaceutical drug products. This book helps fill the gap in the field, examining all areas of biopharmaceuticals manufacturing, from development and formulation to production and packaging. Written by a group of experts from industry and academia, the book focuses on real-world methods for maintaining product integrity throughout the commercialization process, clearly explaining the fundamentals and essential pathways for all development stages. Coverage includes: Research and early development phase appropriate approaches for ensuring product stability Development of commercially viable formulations for liquid and lyophilized dosage forms Optimal storage, packaging, and shipping methods Case studies relating to therapeutic monoclonal antibodies, recombinant proteins, and plasma fractions Useful analysis of successful and failed products Formulation and Process Development Strategies for Manufacturing Biopharma-ceuticals is an essential resource for scientists and engineers in the pharmaceutical and biotech industries, for government and regulatory agencies, and for anyone with an interest in the latest developments in the field.
Download or read book Drug and Biological Development written by Ronald P. Evens and published by Springer Science & Business Media. This book was released on 2007-08-14 with total page 394 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book offers a complete discussion of product development in the pharmaceutical and biotechnology industries from discovery, to product launch, through life cycle management. The book is organized for optimal usefulness in the education and training of health care professionals (MD, PharmD, PhD), at universities. The format is a set of figures, tables and lists, along with detailed narrative descriptions, including real-life examples, illustrations, controversies in industry, and references. The editors and authors of the book are industry and research experts in a variety of disciplines.
Download or read book Techniques for Downstream process for Biologic Drugs and Vaccines written by Basanta Kumara Behera and published by Elsevier. This book was released on 2023-08-01 with total page 280 pages. Available in PDF, EPUB and Kindle. Book excerpt: Techniques for Downstream process for Biologic Drugs and Vaccines provides comprehensive technologies involved in processing postharvest broth to separate the target biological therapeutic products of extracellular or intercellular aspects in nature - to its highest purification form, and to thus make it acceptable to end users. The technologies involved in the post-harvesting of fermented broth are explained in this comprehensive resource in a simplified manner with different case studies to help non-engineering students and scientists easily capture the basic principle of biomass processing technologies and their applications in new projects related to the development and manufacturing of therapeutic bio-products. As conceptual development of biotechnology has taken new shape and style with the integration of medical sciences, physical science, and engineering, and has thus begun the need for the development of microbial or cell line process technology and application for large-scale isolation and purification of metabolites or vaccines through the fermentation process, this book covers the most important aspects. Provides insights into the conceptual strategic drive for manufacturing innovative biologically derived therapeutic compounds for commercial purposes Focuses on how to execute biopharmaceutical portfolio trends to bring sustainable manufacturing process as per guidelines of international regulatory acts Highlights emerging trends in medical sciences on tissue engineering, regenerative medicine, personalized medicines, and various innovative techniques on immunotherapy to fight against life-threatening diseases
Download or read book Guidance framework for testing genetically modified mosquitoes written by and published by World Health Organization. This book was released on 2021-05-18 with total page 196 pages. Available in PDF, EPUB and Kindle. Book excerpt:
