Skip to main content

Hands On Approach For The Conduct Of Nonclinical Studies

In Order to Read Online or Download Hands On Approach For The Conduct Of Nonclinical Studies Full eBooks in PDF, EPUB, Tuebl and Mobi you need to create a Free account. Get any books you like and read everywhere you want. Fast Download Speed ~ Commercial & Ad Free. We cannot guarantee that every book is in the library!

Hands On Approach for the Conduct of Nonclinical Studies

Hands On Approach for the Conduct of Nonclinical Studies Book
Author : Deven Dandekar,Pallavi B. Limaye
Publisher : Academic Press
Release : 2019-03
ISBN : 9780128131008
Language : En, Es, Fr & De

GET BOOK

Book Description :

Hands-on Approach for the Conduct of Nonclinical Studies: A Manual for Anticipating and Avoiding Potential Problems focuses on practical approaches to real-life challenges faced during nonclinical studies, providing insights into the anticipation of potential problems and solutions to problems which may arise, saving time, money and resources. The book outlines Good Laboratory Practice in detail and includes regulatory guidelines, communication, stakeholder information and case studies. It is essential reading for study directors/technical coordinators, quality assurance personnel, all technical staff and project managers. In addition, it offers guidance for those new to the area, while also acting as a reference for senior researchers. Includes an introduction to Good Laboratory Practice (GLP) scenarios and the related regulations Explains aspects of study directorship, including documentation, document review, implementation and execution of preclinical studies Provides a detailed account of the responsibilities of each stakeholder (technical, managerial, sponsor) within the study and how timely they need to act to seamlessly move a project

Pharmaceutical Toxicology in Practice

Pharmaceutical Toxicology in Practice Book
Author : Alberto Lodola,Jeanne Stadler
Publisher : John Wiley & Sons
Release : 2011-03-31
ISBN : 0470922729
Language : En, Es, Fr & De

GET BOOK

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.

Targeted Therapy in Translational Cancer Research

Targeted Therapy in Translational Cancer Research Book
Author : Apostolia-Maria Tsimberidou,Razelle Kurzrock,Kenneth C. Anderson
Publisher : John Wiley & Sons
Release : 2015-10-08
ISBN : 1118468686
Language : En, Es, Fr & De

GET BOOK

Book Description :

Targeted Therapy in Translational Cancer Research for the Translational Oncology series provides a comprehensive overview of recent developments in our understanding of tumor biology, elucidates the roles of targets and pathways involved in carcinogenesis, and describes current state-of-the-art anticancer therapy, as well as the most promising areas of translational research and targeted therapy. Introduces cutting-edge ‘bench to bedside and back’ breakthroughs which have transformed the diagnosis, prognosis, and treatment of cancer Covers basic principles of targeted therapy, including immunotherapy and the roles of cancer stem cells, the microenvironment, angiogenesis, epigenetics, microRNAs, and functional imaging in precision medicine Summarises major advances in therapeutic management of hematologic malignancies and solid tumors using conventional therapy, targeted therapy, immunotherapy, or novel treatment modalities

Translational Medicine

Translational Medicine Book
Author : Joy A. Cavagnaro,Mary Ellen Cosenza
Publisher : CRC Press
Release : 2021-11-26
ISBN : 1000471829
Language : En, Es, Fr & De

GET BOOK

Book Description :

Translational Medicine: Optimizing Preclinical Safety Evaluation of Biopharmaceuticals provides scientists responsible for the translation of novel biopharmaceuticals into clinical trials with a better understanding of how to navigate the obstacles that keep innovative medical research discoveries from becoming new therapies or even making it to clinical trials. The book includes sections on protein-based therapeutics, modified proteins, oligonucleotide-based therapies, monoclonal antibodies, antibody–drug conjugates, gene and cell-based therapies, gene-modified cell-based therapies, combination products, and therapeutic vaccines. Best practices are defined for efficient discovery research to facilitate a science-based, efficient, and predictive preclinical development program to ensure clinical efficacy and safety. Key Features: Defines best practices for leveraging of discovery research to facilitate a development program Includes general principles, animal models, biomarkers, preclinical toxicology testing paradigms, and practical applications Discusses rare diseases Discusses "What-Why-When-How" highlighting different considerations based upon product attributes. Includes special considerations for rare diseases About the Editors Joy A. Cavagnaro is an internationally recognized expert in preclinical development and regulatory strategy with an emphasis on genetic medicines.. Her 40-year career spans academia, government (FDA), and the CRO and biotech industries. She was awarded the 2019 Arnold J Lehman Award from the Society of Toxicology for introducing the concept of science-based, case-by-case approach to preclinical safety evaluation, which became the foundation of ICH S6. She currently serves on scientific advisory boards for advocacy groups and companies and consults and lectures in the area of preclinical development of novel therapies. Mary Ellen Cosenza is a regulatory toxicology consultant with over 30 years of senior leadership experience in the biopharmaceutical industry in the U.S., Europe, and emerging markets. She has held leadership position in both the American College of Toxicology (ACT) and the International Union of Toxicology (IUTOX) and is also an adjunct assistant professor at the University of Southern California where she teaches graduate-level courses in toxicology and regulation of biologics.

Nonclinical Safety Assessment

Nonclinical Safety Assessment Book
Author : William J. Brock,Kenneth L. Hastings,Kathy M. McGown
Publisher : John Wiley & Sons
Release : 2013-03-05
ISBN : 1118516982
Language : En, Es, Fr & De

GET BOOK

Book Description :

Bringing a new drug to market is a costly time-consuming process. Increased regional and international regulation over the last twenty years, while necessary, has only served to amplify these costs. In response to this escalation, developmental strategies have shifted towards a more global approach. In order to create the most cost-effective and safe processes, it is critical for those bringing drugs to market to understand both the globally accepted regulations and the local variations. Nonclinical Safety Assessment: A Guide to International Pharmaceutical Regulations provides a practical description of nonclinical drug development regulations and requirements in the major market regions. It includes: ICH – the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use National regulations, including US FDA, Canada, Mercosur and Brazil, South Africa, China, Japan, India and Australia Repeated dose toxicity studies Carcinogenicity; Genotoxicity; Developmental and reproductive toxicology; Immunotoxicology Biotechnology-derived pharmaceuticals Vaccine development Phototoxicity and photocarcinogenicity Degradants, impurities, excipients and metabolites Primarily intended for those professionals actively involved in the nonclinical and clinical development of a pharmaceutical product, including toxicologists, pharmacologists, clinicians and project managers, this book provides a roadmap for successful new drug approval and marketing.

Global Approach in Safety Testing

Global Approach in Safety Testing Book
Author : Jan Willem van der Laan,Joseph J DeGeorge
Publisher : Springer Science & Business Media
Release : 2013-02-11
ISBN : 1461459508
Language : En, Es, Fr & De

GET BOOK

Book Description :

This volume will consider one of ICH’s major categories, Safety i.e. topics relating to in vitro and in vivo pre-clinical studies (Carcinogenicity Testing, Genotoxicity Testing, etc.). Since the start of the ICH process, many guidelines have been written, but even after ICH6 no explanations have been given during a formal Congress about the background of the ICH Guidance documents. Even more important than what has been written, might have been those thoughts of the experts that are not included in the Guidance documents. Why has the guideline been written as it is written, and why have some aspects been deleted. These and other related questions are the contents of this book, written by experts who were involved in the ICH process. Furthermore, the chapters will contain discussions on the “lessons learnt” and “future developments”.

The Role of the Study Director in Nonclinical Studies

The Role of the Study Director in Nonclinical Studies Book
Author : William J. Brock,Barbara Mounho,Lijie Fu
Publisher : John Wiley & Sons
Release : 2014-05-02
ISBN : 1118874080
Language : En, Es, Fr & De

GET BOOK

Book Description :

A single-source reference with a broad and holistic overview of nonclinical studies, this book offers critical training material and describes regulations of nonclinical testing through guidelines, models, case studies, practical examples, and worldwide perspectives. The book: Provides a complete overview of nonclinical study organization, conduct, and reporting and describes the roles and responsibilities of a Study Director to manage an effective study Covers regulatory and scientific concepts, including international testing and Good Laboratory Practice (GLP), compliance with guidelines, and animal models Features a concluding chapter that compiles case studies / lessons learned from those that have served as a Study Director for many years Addresses the entire spectrum of nonclinical testing, making it applicable to those in the government, laboratories and those actively involved in in all sectors of industry

Handbook of Bioequivalence Testing

Handbook of Bioequivalence Testing Book
Author : Sarfaraz K. Niazi
Publisher : CRC Press
Release : 2014-10-29
ISBN : 1482226383
Language : En, Es, Fr & De

GET BOOK

Book Description :

As the generic pharmaceutical industry continues to grow and thrive, so does the need to conduct adequate, efficient bioequivalence studies. In recent years, there have been significant changes to the statistical models for evaluating bioequivalence. In addition, advances in the analytical technology used to detect drug and metabolite levels have m

Brain Computer Interfaces for Non clinical Home Sports Art Entertainment Education Well being Applications

Brain Computer Interfaces for Non clinical  Home  Sports  Art  Entertainment  Education  Well being  Applications Book
Author : Anton Nijholt,Jose Luis Contreras-Vidal,Camille Jeunet,Aleksander Väljamäe
Publisher : Frontiers Media SA
Release : 2022-03-17
ISBN : 2889747174
Language : En, Es, Fr & De

GET BOOK

Book Description :

Download Brain Computer Interfaces for Non clinical Home Sports Art Entertainment Education Well being Applications book written by Anton Nijholt,Jose Luis Contreras-Vidal,Camille Jeunet,Aleksander Väljamäe, available in PDF, EPUB, and Kindle, or read full book online anywhere and anytime. Compatible with any devices.

Management of Animal Care and Use Programs in Research Education and Testing

Management of Animal Care and Use Programs in Research  Education  and Testing Book
Author : Robert H. Weichbrod,Gail A. (Heidbrink) Thompson,John N. Norton
Publisher : CRC Press
Release : 2017-09-07
ISBN : 1498748457
Language : En, Es, Fr & De

GET BOOK

Book Description :

AAP Prose Award Finalist 2018/19 Management of Animal Care and Use Programs in Research, Education, and Testing, Second Edition is the extensively expanded revision of the popular Management of Laboratory Animal Care and Use Programs book published earlier this century. Following in the footsteps of the first edition, this revision serves as a first line management resource, providing for strong advocacy for advancing quality animal welfare and science worldwide, and continues as a valuable seminal reference for those engaged in all types of programs involving animal care and use. The new edition has more than doubled the number of chapters in the original volume to present a more comprehensive overview of the current breadth and depth of the field with applicability to an international audience. Readers are provided with the latest information and resource and reference material from authors who are noted experts in their field. The book: - Emphasizes the importance of developing a collaborative culture of care within an animal care and use program and provides information about how behavioral management through animal training can play an integral role in a veterinary health program - Provides a new section on Environment and Housing, containing chapters that focus on management considerations of housing and enrichment delineated by species - Expands coverage of regulatory oversight and compliance, assessment, and assurance issues and processes, including a greater discussion of globalization and harmonizing cultural and regulatory issues - Includes more in-depth treatment throughout the book of critical topics in program management, physical plant, animal health, and husbandry. Biomedical research using animals requires administrators and managers who are knowledgeable and highly skilled. They must adapt to the complexity of rapidly-changing technologies, balance research goals with a thorough understanding of regulatory requirements and guidelines, and know how to work with a multi-generational, multi-cultural workforce. This book is the ideal resource for these professionals. It also serves as an indispensable resource text for certification exams and credentialing boards for a multitude of professional societies Co-publishers on the second edition are: ACLAM (American College of Laboratory Animal Medicine); ECLAM (European College of Laboratory Animal Medicine); IACLAM (International Colleges of Laboratory Animal Medicine); JCLAM (Japanese College of Laboratory Animal Medicine); KCLAM (Korean College of Laboratory Animal Medicine); CALAS (Canadian Association of Laboratory Animal Medicine); LAMA (Laboratory Animal Management Association); and IAT (Institute of Animal Technology).

A Comprehensive Guide to Toxicology in Nonclinical Drug Development

A Comprehensive Guide to Toxicology in Nonclinical Drug Development Book
Author : Ali S. Faqi
Publisher : Academic Press
Release : 2016-11-03
ISBN : 0128036214
Language : En, Es, Fr & De

GET BOOK

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

A Comprehensive Guide to Toxicology in Preclinical Drug Development

A Comprehensive Guide to Toxicology in Preclinical Drug Development Book
Author : Ali S. Faqi
Publisher : Academic Press
Release : 2012-11-16
ISBN : 0123878152
Language : En, Es, Fr & De

GET BOOK

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

Principles of Research Data Audit

Principles of Research Data Audit Book
Author : Adil E. Shamoo
Publisher : Taylor & Francis
Release : 1989
ISBN : 9782881243790
Language : En, Es, Fr & De

GET BOOK

Book Description :

First Published in 1989. Routledge is an imprint of Taylor & Francis, an informa company.

Handbook of LC MS Bioanalysis

Handbook of LC MS Bioanalysis Book
Author : Wenkui Li,Jie Zhang,Francis L. S. Tse
Publisher : John Wiley & Sons
Release : 2013-09-03
ISBN : 111867135X
Language : En, Es, Fr & De

GET BOOK

Book Description :

Consolidates the information LC-MS bioanalytical scientistsneed to analyze small molecules and macromolecules The field of bioanalysis has advanced rapidly, propelled by newapproaches for developing bioanalytical methods, new liquidchromatographic (LC) techniques, and new mass spectrometric (MS)instruments. Moreover, there are a host of guidelines andregulations designed to ensure the quality of bioanalyticalresults. Presenting the best practices, experimental protocols, and thelatest understanding of regulations, this book offers acomprehensive review of LC-MS bioanalysis of small molecules andmacromolecules. It not only addresses the needs of bioanalyticalscientists working on routine projects, but also explores advancedand emerging technologies such as high-resolution mass spectrometryand dried blood spot microsampling. Handbook of LC-MS Bioanalysis features contributions froman international team of leading bioanalytical scientists. Theircontributions reflect a review of the latest findings, practices,and regulations as well as their own firsthand analyticallaboratory experience. The book thoroughly examines: Fundamentals of LC-MS bioanalysis in drug discovery, drugdevelopment, and therapeutic drug monitoring The current understanding of regulations governing LC-MSbioanalysis Best practices and detailed technical instructions for LC-MSbioanalysis method development, validation, and stabilityassessment of analyte(s) of interest Experimental guidelines and protocols for quantitative LC-MSbioanalysis of challenging molecules, including pro-drugs, acylglucuronides, N-oxides, reactive compounds, and photosensitive andautooxidative compounds With its focus on current bioanalytical practice, Handbook ofLC-MS Bioanalysis enables bioanalytical scientists to developand validate robust LC-MS assay methods, all in compliance withcurrent regulations and standards.

Neuroethics in Practice

Neuroethics in Practice Book
Author : Anjan Chatterjee,Martha J. Farah
Publisher : Oxford University Press
Release : 2013-01-17
ISBN : 0195389786
Language : En, Es, Fr & De

GET BOOK

Book Description :

This book explores relevant questions within this multi-faceted and rapidly growing field, and will help to define and foster scholarship within the intersection of neuroethics and clinical neuroscience.

Handbook of Research on Automated Feature Engineering and Advanced Applications in Data Science

Handbook of Research on Automated Feature Engineering and Advanced Applications in Data Science Book
Author : Panda, Mrutyunjaya,Misra, Harekrishna
Publisher : IGI Global
Release : 2021-01-08
ISBN : 1799866610
Language : En, Es, Fr & De

GET BOOK

Book Description :

In today’s digital world, the huge amount of data being generated is unstructured, messy, and chaotic in nature. Dealing with such data, and attempting to unfold the meaningful information, can be a challenging task. Feature engineering is a process to transform such data into a suitable form that better assists with interpretation and visualization. Through this method, the transformed data is more transparent to the machine learning models, which in turn causes better prediction and analysis of results. Data science is crucial for the data scientist to assess the trade-offs of their decisions regarding the effectiveness of the machine learning model implemented. Investigating the demand in this area today and in the future is a necessity. The Handbook of Research on Automated Feature Engineering and Advanced Applications in Data Science provides an in-depth analysis on both the theoretical and the latest empirical research findings on how features can be extracted and transformed from raw data. The chapters will introduce feature engineering and the recent concepts, methods, and applications with the use of various data types, as well as examine the latest machine learning applications on the data. While highlighting topics such as detection, tracking, selection techniques, and prediction models using data science, this book is ideally intended for research scholars, big data scientists, project developers, data analysts, and computer scientists along with practitioners, researchers, academicians, and students interested in feature engineering and its impact on data.

Toxicologic Pathology

Toxicologic Pathology Book
Author : Pritam S. Sahota,James A. Popp,Jerry F. Hardisty,Chirukandath Gopinath,Page Bouchard
Publisher : CRC Press
Release : 2018-08-31
ISBN : 0429997450
Language : En, Es, Fr & De

GET BOOK

Book Description :

Following the success of the first edition, this book is designed to provide practical and timely information for toxicologic pathologists working in pharmaceutical drug discovery and development. The majority of the book (Organ Systems) will provide detailed descriptions of histopathological lesions observed in drug development. In addition, it will provide information to assist the pathologist in making determinations of the origin of lesions as well as its relevance to human risk. Toxicologic Pathology: Nonclinical Safety Assessment, Second Edition includes 2 new concept chapters. The first of the new chapters address approaches for the evaluation of unique therapeutic modalities such as cell therapies, gene therapies, and gene expression knockdown therapies. While these still represent new developing therapeutic approaches, there has been significant experience with the therapeutic modalities in the last 5 years. The second new chapter addresses the nonclinical safety assessment of medical devices, a topic of increasing importance that was not addressed in a unique chapter in the first edition. The other concept chapters have been updated and cover important topics including the overview of drug development; principles of nonclinical safety assessment; an introduction to toxicologic pathology; techniques used in toxicologic pathology, clinical pathology, toxicokinetics, and drug development toxicogenomics; and spontaneous lesions. The 13 organ system chapters provide the specifics related to pathologic characteristics, differential diagnosis, and interpretation of toxic responses in each organ system. These chapters are specifically important for the bench pathologist but also for the toxicologist who interacts with pathologists and function as study toxicologists and project team representatives in the drug development arena.

Contextual Behavior Therapy for Sexual and Gender Minority Clients

Contextual Behavior Therapy for Sexual and Gender Minority Clients Book
Author : Matthew D. Skinta
Publisher : Routledge
Release : 2020-11-23
ISBN : 0429638531
Language : En, Es, Fr & De

GET BOOK

Book Description :

Combining theory, research, and case studies, this book shows clinicians how to apply transdiagnostic contextual behavioral approaches when working with sexual and gender minority (SGM) clients. The text first examines minority stress theory through the lens of contextual behavior analysis. Subsequent chapters illustrate the application of therapeutic techniques drawn from acceptance and commitment therapy, functional analytic psychotherapy, and compassion-focused therapy. The book concludes with a close look at special areas of consideration, including pre-surgical evaluation, the impact of HIV on SGM communities, ethical considerations, and future directions in therapy with SGM clients. Every chapter provides a series of diverse vignettes that illustrate how each aspect of treatment might build upon the last along with a list of recommended books for further exploration of that topic. This book offers a unique, integrated approach that can be used for case conceptualization and followed as a treatment manual for professionals or graduate students with a foundation in SGM psychology.

Alzheimer s Disease Original Mechanisms and Translational Impact

Alzheimer   s Disease  Original Mechanisms and Translational Impact Book
Author : Cesare Mancuso,Silvana Gaetani
Publisher : Frontiers Media SA
Release : 2020-04-03
ISBN : 2889636313
Language : En, Es, Fr & De

GET BOOK

Book Description :

Download Alzheimer s Disease Original Mechanisms and Translational Impact book written by Cesare Mancuso,Silvana Gaetani, available in PDF, EPUB, and Kindle, or read full book online anywhere and anytime. Compatible with any devices.