A Comprehensive Guide to Toxicology in Preclinical Drug Development

Author: Ali S. Faqi
Publisher: Academic Press
ISBN: 0123878160
Category : Medical
Languages : en
Pages : 903

Book Description
A Comprehensive Guide to Toxicology in Preclinical Drug Development is a resource for toxicologists in industry and regulatory settings, as well as directors working in contract resource organizations, who need a thorough understanding of the drug development process. Incorporating real-life case studies and examples, the book is a practical guide that outlines day-to-day activities and experiences in preclinical toxicology. This multi-contributed reference provides a detailed picture of the complex and highly interrelated activities of preclinical toxicology in both small molecules and biologics. The book discusses discovery toxicology and the international guidelines for safety evaluation, and presents traditional and nontraditional toxicology models. Chapters cover development of vaccines, oncology drugs, botanic drugs, monoclonal antibodies, and more, as well as study development and personnel, the role of imaging in preclinical evaluation, and supporting materials for IND applications. By incorporating the latest research in this area and featuring practical scenarios, this reference is a complete and actionable guide to all aspects of preclinical drug testing. - Chapters written by world-renowned contributors who are experts in their fields - Includes the latest research in preclinical drug testing and international guidelines - Covers preclinical toxicology in small molecules and biologics in one single source

A Comprehensive Guide to Toxicology in Nonclinical Drug Development

Author: Ali S. Faqi
Publisher: Academic Press
ISBN: 0128036214
Category : Medical
Languages : en
Pages : 988

Book Description
A Comprehensive Guide to Toxicology in Nonclinical Drug Development, Second Edition, is a valuable reference designed to provide a complete understanding of all aspects of nonclinical toxicology in the development of small molecules and biologics. This updated edition has been reorganized and expanded to include important topics such as stem cells in nonclinical toxicology, inhalation and dermal toxicology, pitfalls in drug development, biomarkers in toxicology, and more. Thoroughly updated to reflect the latest scientific advances and with increased coverage of international regulatory guidelines, this second edition is an essential and practical resource for all toxicologists involved in nonclinical testing in industry, academic, and regulatory settings. Provides unique content that is not always covered together in one comprehensive resource, including chapters on stem cells, abuse liability, biomarkers, inhalation toxicology, biostatistics, and more Updated with the latest international guidelines for nonclinical toxicology in both small and large molecules Incorporates practical examples in order to illustrate day-to-day activities and the expectations associated with working in nonclinical toxicology

Drug Discovery Toxicology

Author: Yvonne Will
Publisher: John Wiley & Sons
ISBN: 1119053390
Category : Medical
Languages : en
Pages : 899

Book Description
As a guide for pharmaceutical professionals to the issues and practices of drug discovery toxicology, this book integrates and reviews the strategy and application of tools and methods at each step of the drug discovery process. • Guides researchers as to what drug safety experiments are both practical and useful • Covers a variety of key topics – safety lead optimization, in vitro-in vivo translation, organ toxicology, ADME, animal models, biomarkers, and –omics tools • Describes what experiments are possible and useful and offers a view into the future, indicating key areas to watch for new predictive methods • Features contributions from firsthand industry experience, giving readers insight into the strategy and execution of predictive toxicology practices

Pharmaceutical Toxicology in Practice

Author: Alberto Lodola
Publisher: John Wiley & Sons
ISBN: 0470922729
Category : Medical
Languages : en
Pages : 280

Book Description
This book describes, with references to key source materials, the background to, and conduct of, the principal nonclinical studies that are central to drug development. The chapters provide an understanding of the key components of the preclinical phase of drug development with a hands-on description, with core chapters addressing study conduct, types, and reporting. As such, it is a practical guide through toxicology testing and an up-to-date reference on current issues, new developments, and future directions in toxicology. Opening with a practical description of toxicology and its role in the development of pharmaceuticals, the book proceeds to detail international regulations (including the impact of the new REACH standards for chemical safety), interdisciplinary interactions among scientists in drug development, steps in toxicity testing, and risk management. Further, the book covers the methods of genetic toxicology (assays, genomics, in vivo screening) as a complement to “traditional” toxicology in the risk assessment and risk management of pharmaceuticals.

Principles of Translational Science in Medicine

Author: Martin Wehling
Publisher: Academic Press
ISBN: 0128007214
Category : Science
Languages : en
Pages : 365

Book Description
Principles of Translational Science in Medicine: From Bench to Bedside, Second Edition, provides an update on major achievements in the translation of research into medically relevant results and therapeutics. The book presents a thorough discussion of biomarkers, early human trials, and networking models, and includes institutional and industrial support systems. It also covers algorithms that have influenced all major areas of biomedical research in recent years, resulting in an increasing numbers of new chemical/biological entities (NCEs or NBEs) as shown in FDA statistics. The book is ideal for use as a guide for biomedical scientists to establish a systematic approach to translational medicine. - Provides an in-depth description of novel tools for the assessment of translatability of trials to balance risk and improve projects at any given stage of product development - New chapters deal with translational issues in the fastest growing population (the elderly), case studies, translatability assessment tools, and advances in nanotherapies - Details IPR issues of translation, especially for public-private-partnerships - Contains contributions from world leaders in translational medicine, including the former NIH director and authorities from various European regulatory institutions

Pharmaceutical Toxicology

Author: Gerard J. Mulder
Publisher:
ISBN:
Category : Business & Economics
Languages : en
Pages : 284

Book Description
Toxicology studies are carried out on all drug substances to ensure safety. This book provides an overview of the methodology andrequirements of pre-clinical safety assessments of new medicines. with the focus on medicinal drugs - the most important safety issues of drugs are covered, including registration requirements of new drugs and pharmacovigilance. This is an introductory text for students at BSc, MSc and PhD levels,and will be an excellent companion to pharmacology textbooks, combining a broad treatment of the issues relevant for assessing the safety/efficacy balance of a new drug wit

Medical Toxicology of Drug Abuse

Author: Donald G. Barceloux
Publisher: John Wiley & Sons
ISBN: 1118106059
Category : Science
Languages : en
Pages : 1080

Book Description
This book provides a broad reference covering important drugs of abuse including amphetamines, opiates, and steroids. It also covers psychoactive plants such as caffeine, peyote, and psilocybin. It provides chemical structures, analytical methods, clinical features, and treatments of these drugs of abuse, serving as a highly useful, in-depth supplement to a general medical toxicology book. The style allows for the easy application of the contents to searchable databases and other electronic products, making this an essential resource for practitioners in medical toxicology, industrial hygiene, occupational medicine, pharmaceuticals, environmental organizations, pathology, and related fields.

Toxicology

Author: Vinood B. Patel
Publisher: Academic Press
ISBN: 0128190930
Category : Medical
Languages : en
Pages : 596

Book Description
Toxicology: Oxidative Stress and Dietary Antioxidants examines the nature of oxidative stress as a consequence of exposure to toxins and how antioxidant approaches can mitigate the impact of toxicant exposures. Sections covers the basic biology of oxidative stress, from molecular biology, to physiological pathology, mechanisms of action of specific toxicants, metals and other chemicals/drugs, and antioxidant approaches and therapies for toxic exposures. With contributions from an international group of experts, useful summary sections, a dictionary of terms, and applications to other areas of toxicology, this book is an informative, consolidated reference that helps bridge the interrelationship between toxicology, oxidative stress and antioxidants. - Provides a novel collection of information linking both sides of redox biology (oxidants and antioxidants) and toxicology - Explores the role of free radical mediated damage and toxicology - Contains contributions from experts on toxicological science surrounding oxidative stress and on antioxidant approaches for reducing the impact of toxicant exposures

Clarke's Analytical Forensic Toxicology

Author: Gail Cooper
Publisher: Pharmaceutical Press
ISBN: 0857110543
Category : Law
Languages : en
Pages : 657

Book Description
This invaluable textbook, written by international experts, covers all the main elements of forensic toxicology and analytical toxicology techniques as well as the important parts of pharmacokinetics, drug metabolism, and pharmacology in general, with a particular focus on drugs of abuse.

Toxicology for the Health and Pharmaceutical Sciences

Author: Antonio Peña-Fernández
Publisher:
ISBN: 9781032100227
Category : Chemicals
Languages : en
Pages :

Book Description
"There is an increasing need for knowledge of toxicology to safeguard the use of chemicals in industry, public and private sectors. The study of toxicology is becoming increasingly relevant in human health sciences, as future health and clinical professionals will be pivotal to address and manage emerging chemical threats and hazards related to modern anthropogenic activities and technological development. Comprising a series of chapters from leading toxicology, pharmacy and public health academics and experts across Europe, the United States and beyond, Toxicology for the Health and Pharmaceutical Sciences provides a concise yet comprehensive volume that can be used as a relevant textbook on toxicology for the clinical, healthcare, educational and professional sectors. This book covers the fundamentals and recent developments in toxicology, to respond to local and global chemical, pharmaceutical and environmental threats. Thus, this volume has chapters specifically designed to support the understanding of the most current, toxicology-related subjects for any undergraduate/postgraduate health programmes, as well as aiding with the delivery of continuing professional development training on up-to-date topics in toxicology for current practicing health professionals wishing to improve their background knowledge in toxicology. The book is also vital reading, and reference for policy makers, and others that influence, and decide regulations that have an impact on the environment, and human health"--