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Author: Ali S. Faqi
Publisher: Academic Press
ISBN: 0128036214
Category : Medical
Languages : en
Pages : 988
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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
Author: Ali S. Faqi
Publisher: Academic Press
ISBN: 0128036214
Category : Medical
Languages : en
Pages : 988
Get Book Here
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
Author: Ingeborg Van der Ploeg
Publisher:
ISBN:
Category : Bacterial toxins
Languages : en
Pages : 194
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Book Description
Author: Thomas J. Dougherty
Publisher: Springer Science & Business Media
ISBN: 1461414008
Category : Medical
Languages : en
Pages : 1119
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Book Description
This volume covers all aspects of the antibiotic discovery and development process through Phase II/III. The contributors, a group of highly experienced individuals in both academics and industry, include chapters on the need for new antibiotic compounds, strategies for screening for new antibiotics, sources of novel synthetic and natural antibiotics, discovery phases of lead development and optimization, and candidate compound nominations into development. Beyond discovery , the handbook will cover all of the studies to prepare for IND submission: Phase I (safety and dose ranging), progression to Phase II (efficacy), and Phase III (capturing desired initial indications). This book walks the reader through all aspects of the process, which has never been done before in a single reference. With the rise of antibiotic resistance and the increasing view that a crisis may be looming in infectious diseases, there are strong signs of renewed emphasis in antibiotic research. The purpose of the handbook is to offer a detailed overview of all aspects of the problem posed by antibiotic discovery and development.
Author: Dorland
Publisher: Elsevier Health Sciences
ISBN: 0323442544
Category : Medical
Languages : en
Pages : 481
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Book Description
Medical acronyms and abbreviations offer convenience, but those countless shortcuts can often be confusing. Now a part of the popular Dorland's suite of products, this reference features thousands of terms from across various medical specialties. Its alphabetical arrangement makes for quick reference, and expanded coverage of symbols ensures they are easier to find. Effective communication plays an important role in all medical settings, so turn to this trusted volume for nearly any medical abbreviation you might encounter. - Symbols section makes it easier to locate unusual or seldom-used symbols. - Convenient alphabetical format allows you to find the entry you need more intuitively. - More than 90,000 entries and definitions. - Many new and updated entries including terminology in expanding specialties, such as Nursing; Physical, Occupational, and Speech Therapies; Transcription and Coding; Computer and Technical Fields. - New section on abbreviations to avoid, including Joint Commission abbreviations that are not to be used. - Incorporates updates suggested by the Institute for Safe Medication Practices (ISMP).
Author: John A. Vaughn
Publisher: Springer Nature
ISBN: 303056309X
Category : Medical
Languages : en
Pages : 336
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Book Description
This unique and comprehensive title offers state-of-the-art guidance on all of the clinical principles and practices needed in providing optimal health and well-being services for college students. Designed for college health professionals and administrators, this highly practical title is comprised of 24 chapters organized in three sections: Common Clinical Problems in College Health, Organizational and Administrative Considerations for College Health, and Population and Public Health Management on a College Campus. Section I topics include travel health services, tuberculosis, eating disorders in college health, and attention deficit hyperactivity disorder among college students, along with several other chapters. Subsequent chapters in Section II then delve into topics such as supporting the health and well-being of a diverse student population, student veterans, health science students, student safety in the clinical setting, and campus management of infectious disease outbreaks, among other topics. The book concludes with organizational considerations such as unique issues in the practice of medicine in the institutional context, situating healthcare within the broader context of wellness on campus, organizational structures of student health, funding student health services, and delivery of innovative healthcare services in college health. Developed by a renowned, multidisciplinary authorship of leaders in college health theory and practice, and coinciding with the founding of the American College Health Association 100 years ago, Principles and Practice of College Health will be of great interest to college health and well-being professionals as well as college administrators.
Author: Robert Malcolm Kaplan
Publisher: Agency for Healthcare Research and Quality
ISBN: 9781587634444
Category : Health behavior
Languages : en
Pages : 431
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Book Description
Author: Ali S. Faqi
Publisher: Academic Press
ISBN: 0123878160
Category : Medical
Languages : en
Pages : 903
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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
Author: Burt Anderson
Publisher: Springer Science & Business Media
ISBN: 0387281592
Category : Science
Languages : en
Pages : 251
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Book Description
The purpose of this book is to bring together, in a single volume, the most up-to-date information concerning microbes with potential as bioterrorist weapons. The primary audience includes microbiologists, including bacteriologists, virologists and mycologists, in academia, government laboratories and research institutes at the forefront of studies concerning microbes which have potential as bioterrorist weapons, public health physicians and researchers and scientists who must be trained to deal with bioterrorist attacks as well as laboratory investigators who must identify and characterize these microorganisms from the environment and from possibly infected patients.
Author: Muhammad Zaffar Hashmi
Publisher: Springer Nature
ISBN: 3030404226
Category : Science
Languages : en
Pages : 466
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Book Description
This volume summarizes and updates information about antibiotics and antimicrobial resistance (AMR)/antibiotic resistant genes (ARG) production, including their entry routes in soil, air, water and sediment, their use in hospital and associated waste, global and temporal trends in use and spread of antibiotics, AMR and ARG. Antimicrobial/antibiotic resistance genes due to manure and agricultural waste applications, bioavailability, biomonitoring, and their Epidemiological, ecological and public health effects. The book addresses the antibiotic and AMR/ARG risk assessment and treatment technologies, for managing antibiotics and AMR/ARG impacted environments The book's expert contributions span 20 chapters, and offer a comprehensive framework for better understanding and analyzing the environmental and social impacts of antibiotics and AMR/ARGs. Readers will have access to recent and updated models regarding the interpretation of antibiotics and AMR/ARGs in environment and biomonitoring studies, and will learn about the management options require to appropriately mitigate environmental contaminants and pollution. The book will be of interest to students, teachers, researchers, policy makers and environmental organizations.
Author: John Geigert
Publisher: Springer
ISBN: 3030137546
Category : Medical
Languages : en
Pages : 446
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Book Description
Biopharmaceuticals (i.e., biological medicines sourced from genetically-engineered living systems) for treatment of human diseases have become a significant percentage of the pharmaceutical industry. And not just the recombinant DNA-derived proteins and monoclonal antibodies (both from the innovators and biosimilars); but now, an increasing awareness of the importance of gene therapy and genetically engineered cellular medicinal products. These biopharmaceuticals are being developed by many companies whose Chemistry, Manufacturing & Control (CMC) teams have varying degrees of familiarity or experience with the CMC strategy and regulatory compliance requirements for these challenging products. Companies clearly plan out the strategy for their clinical study plans, but frequently, the development of a strategy for CMC is an afterthought. Coupled with the complexity of the biopharmaceutical manufacturing processes and products, and this can be a recipe for disaster. The third edition of this book provides insights and practical guidance for the CMC teams to develop an acceptable cost-effective, risk-based CMC regulatory compliance strategy for all biopharmaceuticals (recombinant proteins, monoclonal antibodies, genetically engineered viruses and genetically engineered human cells) from early clinical stage development through market approval. The third edition of this book provides added coverage for the biosimilars, antibody drug conjugates (ADCs), bispecific antibodies, genetically engineered viruses, and genetically engineered cells. This third edition of the book also addresses the heightened pressure on CMC regulatory compliance timelines due to the introduction of expedited clinical pathways moving the clinical development closer to a seamless phase process (e.g., FDA Breakthrough Therapy designation, CBER Regenerative Medicine Advanced Therapy (RMAT) designation, EMA Priority Medicines (PRIME) designation). The Challenge of CMC Regulatory Compliance for Biopharmaceuticals is essential, practical information for all pharmaceutical development scientists, Manufacturing and Quality Unit staff, Regulatory Affairs personnel, and senior management involved in the manufacture of biopharmaceuticals.
