[PDF] Principles For The Testing Of Drugs For Teratogenicity eBook

Author : Luís Félix
Publisher : Humana
Page : 0 pages
File Size : 13,25 MB
Release : 2024-02-24
Category : Science
ISBN : 9781071636244

GET BOOK

This fully updated volume collects laboratory techniques and tests to assess the risks to embryo-fetal development from drug exposure during early developmental stages. Beginning with a section detailing basic principles of teratogenicity, the book continues with application of in vitro models for teratogenic screening to predict toxicity in embryonic animals and humans, as well as a variety of well-established in vivo animal model tests, which offer solutions for evaluating the efficacy and the teratogenicity of compounds in preclinical trials before human safety testing. Written for the highly successful Methods in Molecular Biology series, chapters include introductions to their respective topics, lists of the necessary materials and reagents, step-by-step and readily reproducible laboratory protocols, and tips on troubleshooting and avoiding known pitfalls. Authoritative and practical, Teratogenicity Testing: Methods and Protocols, Second Edition serves as an ideal guide to tests that can be performed in cells, organs, tissues, and animal models for evaluating toxicity and/or safety of compounds in early developmental stages with the goal of estimating, preventing, or minimizing the teratogenic potential of drugs.

Author : Luís Félix
Publisher : Humana
Page : 614 pages
File Size : 42,87 MB
Release : 2019-06-27
Category : Medical
ISBN : 9781493993147

GET BOOK

This detailed book provides a compilation of laboratory techniques and tests to assess the risks to embryo-fetal development from drug exposure during early developmental stages. After an introduction to teratogenicity testing, the contents explore both in vitro and in vivo techniques in the study of the teratogenic and fetotoxic effects of drugs, as well as numerous animal-based teratology methods. Written in the highly successful Methods in Molecular Biology series format, chapters include introductions to their respective topics, lists of the necessary materials and reagents, step-by-step, readily reproducible laboratory protocols, and tips on troubleshooting and avoiding known pitfalls. Authoritative and comprehensive, Teratogenicity Testing: Methods and Protocols describes methods that integrate a battery of tests that can be performed in cells, organs, tissues, and animal models for evaluating toxicity and/or the safety of compounds in early developmental stages with the goal of estimating, preventing, or minimizing the teratogenic potential of drugs.

Author : Paul C. Barrow
Publisher : Humana Press
Page : 0 pages
File Size : 30,25 MB
Release : 2012-11-09
Category : Medical
ISBN : 9781627031301

GET BOOK

Teratology is the study of chemical-induced birth defects. This book is a comprehensive guide to the procedures and methods commonly employed in the safety testing of all classes of chemical for teratogenicity (also referred to as embryotoxicity, developmental toxicity or prenatal toxicity). The various international regulatory requirements are explained in detail, in order that the reader may perform all of the necessary studies for the successful registration or marketing authorisation of a new pharmaceutical, industrial chemical, crop protection product or food additive. Written in the highly successful Methods in Molecular BiologyTM series format, each chapter gives clear complete instructions on how to perform the task in hand. The authors are respected experts in their field, all with hands-on experience of the procedures described. Teratogenicity Testing: Methods and Protocols gives crucial guidance and tips on how to deal with unexpected results and overcome regulatory difficulties.

Author : Hung N. Winn
Publisher : CRC Press
Page : 855 pages
File Size : 45,64 MB
Release : 2021-09-01
Category : Medical
ISBN : 1000533735

GET BOOK

This is a comprehensive, one-stop online book relating to all areas of pregnancy and birth. The second edition of this easily searchable guide is edited by eminent experts in the field and includes new contributions from international authors. It will be an ideal reference for Maternal-Fetal Specialists and Generalists wanting an authoritative answer on any point. Key features: •Grouped in to six topics (modules) for convenience •Electronic search facility across all chapters •Approximately 700,000 words of text, 7000 references, 300 figures (including 100 in full colour), and 200 tables available to search Key topics: •All common pregnancy and birth related problems such as diabetes and pregnancy •Many rarer complications such as protozoan infections •Fetal assessment, which is absolutely central to MFM practice •Medico-legal aspects •Sickle cell disease – a major problem for patients of African descent New chapters include: •Recurrent early pregnancy losses •Invasive hemodynamic monitoring •Chronic and acute hypertension •Neurological disorders •Maternal obesity •Assessment of fetal genetic disorders •First and second trimester screening

Author : Alan M. Hoberman
Publisher : John Wiley & Sons
Page : 389 pages
File Size : 30,1 MB
Release : 2012-03-13
Category : Medical
ISBN : 047044861X

GET BOOK

This book explains the importance and practice of pediatric drug testing for pharmaceutical and toxicology professionals. It describes the practical and ethical issues regarding non-clinical testing to meet US FDA Guidelines, differences resulting from the new European EMEA legislation, and how to develop appropriate information for submission to both agencies. It also provides practical study designs and approaches that can be used to meet international requirements. Covering the full scope of non-clinical testing, regulations, models, practice, and relation to clinical trials, this text offers a comprehensive and up-to-date resource.

Author : Thomas H. Shepard
Publisher : JHU Press
Page : 564 pages
File Size : 42,58 MB
Release : 2004
Category : Teratogenic agents
ISBN : 9780801879531

GET BOOK

Links information on experimental teratogenic agents with the congenital defects in human beings.

Author : Agency for Healthcare Research and Quality/AHRQ
Publisher : Government Printing Office
Page : 385 pages
File Size : 11,39 MB
Release : 2014-04-01
Category : Medical
ISBN : 1587634333

GET BOOK

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.