Author: Robert A. McArthur
Publisher: Academic Press
ISBN: 0080920403
Category : Medical
Languages : en
Pages : 426
Book Description
Reward Deficit Disorders is written for researchers in both academia and the pharmaceutical industry who use animal models in research and development of drugs for reward deficit disorders such as alcohol dependence, nicotine dependence, heroin and cocaine addiction, obesity, and gambling and impulse control disorders. Reward Deficit Disorders has introductory chapters expressing the view of the role and relevance of animal models for drug discovery and development for the treatment of psychiatric disorders from the perspective of (a) academic basic neuroscientific research, (b) applied pharmaceutical drug discovery and development, and (c) issues of clinical trial design and regulatory agencies limitations. Each volume examines the rationale, use, robustness and limitations of animal models in each therapeutic area covered and discuss the use of animal models for target identification and validation. The clinical relevance of animal models is discussed in terms of major limitations in cross-species comparisons, clinical trial design of drug candidates, and how clinical trial endpoints could be improved. Reward Deficit Disorders also has a section dedicated to the specifics of the regulatory aspects to abuse liability testing. The aim of this series of volumes on Animal and Translational Models for CNS Drug Discovery is to identify and provide common endpoints between species that can serve to inform both the clinic and the bench with the information needed to accelerate clinically-effective CNS drug discovery. This is the third volume in the three volume-set, Animal and Translational Models for CNS Drug Discovery 978-0-12-373861-5, which is also available for purchase individually. - Provides clinical, academic, government and industry perspectives fostering integrated communication between principle participants at all stages of the drug discovery process - Critical evaluation of animal and translational models improving transition from drug discovery and clinical development - Emphasizes what results mean to the overall drug discovery process - Explores issues in clinical trial design and conductance in each therapeutic area - Neurological Disorders is available for purchase individually.
Animal and Translational Models for CNS Drug Discovery: Reward Deficit Disorders
Author: Robert A. McArthur
Publisher: Academic Press
ISBN: 0080920403
Category : Medical
Languages : en
Pages : 426
Book Description
Reward Deficit Disorders is written for researchers in both academia and the pharmaceutical industry who use animal models in research and development of drugs for reward deficit disorders such as alcohol dependence, nicotine dependence, heroin and cocaine addiction, obesity, and gambling and impulse control disorders. Reward Deficit Disorders has introductory chapters expressing the view of the role and relevance of animal models for drug discovery and development for the treatment of psychiatric disorders from the perspective of (a) academic basic neuroscientific research, (b) applied pharmaceutical drug discovery and development, and (c) issues of clinical trial design and regulatory agencies limitations. Each volume examines the rationale, use, robustness and limitations of animal models in each therapeutic area covered and discuss the use of animal models for target identification and validation. The clinical relevance of animal models is discussed in terms of major limitations in cross-species comparisons, clinical trial design of drug candidates, and how clinical trial endpoints could be improved. Reward Deficit Disorders also has a section dedicated to the specifics of the regulatory aspects to abuse liability testing. The aim of this series of volumes on Animal and Translational Models for CNS Drug Discovery is to identify and provide common endpoints between species that can serve to inform both the clinic and the bench with the information needed to accelerate clinically-effective CNS drug discovery. This is the third volume in the three volume-set, Animal and Translational Models for CNS Drug Discovery 978-0-12-373861-5, which is also available for purchase individually. - Provides clinical, academic, government and industry perspectives fostering integrated communication between principle participants at all stages of the drug discovery process - Critical evaluation of animal and translational models improving transition from drug discovery and clinical development - Emphasizes what results mean to the overall drug discovery process - Explores issues in clinical trial design and conductance in each therapeutic area - Neurological Disorders is available for purchase individually.
Publisher: Academic Press
ISBN: 0080920403
Category : Medical
Languages : en
Pages : 426
Book Description
Reward Deficit Disorders is written for researchers in both academia and the pharmaceutical industry who use animal models in research and development of drugs for reward deficit disorders such as alcohol dependence, nicotine dependence, heroin and cocaine addiction, obesity, and gambling and impulse control disorders. Reward Deficit Disorders has introductory chapters expressing the view of the role and relevance of animal models for drug discovery and development for the treatment of psychiatric disorders from the perspective of (a) academic basic neuroscientific research, (b) applied pharmaceutical drug discovery and development, and (c) issues of clinical trial design and regulatory agencies limitations. Each volume examines the rationale, use, robustness and limitations of animal models in each therapeutic area covered and discuss the use of animal models for target identification and validation. The clinical relevance of animal models is discussed in terms of major limitations in cross-species comparisons, clinical trial design of drug candidates, and how clinical trial endpoints could be improved. Reward Deficit Disorders also has a section dedicated to the specifics of the regulatory aspects to abuse liability testing. The aim of this series of volumes on Animal and Translational Models for CNS Drug Discovery is to identify and provide common endpoints between species that can serve to inform both the clinic and the bench with the information needed to accelerate clinically-effective CNS drug discovery. This is the third volume in the three volume-set, Animal and Translational Models for CNS Drug Discovery 978-0-12-373861-5, which is also available for purchase individually. - Provides clinical, academic, government and industry perspectives fostering integrated communication between principle participants at all stages of the drug discovery process - Critical evaluation of animal and translational models improving transition from drug discovery and clinical development - Emphasizes what results mean to the overall drug discovery process - Explores issues in clinical trial design and conductance in each therapeutic area - Neurological Disorders is available for purchase individually.
Animal and Translational Models for CNS Drug Discovery: Neurological Disorders
Author: Robert A. McArthur
Publisher: Academic Press
ISBN: 0080920381
Category : Medical
Languages : en
Pages : 413
Book Description
Neurological Disorders is written for researchers in both academia and the pharmaceutical industry who use animal models in research and development of drugs for neurological disorders such as neurofibromatosis, Alzheimer's disease, Parkinson's disease, Huntington disease, ALS, and the epilepsies. Neurological Disorders has introductory chapters expressing the view of the role and relevance of animal models for drug discovery and development for the treatment of psychiatric disorders from the perspective of (a) academic basic neuroscientific research, (b) applied pharmaceutical drug discovery and development, and (c) issues of clinical trial design and regulatory agencies limitations. Each volume examines the rationale, use, robustness and limitations of animal models in each therapeutic area covered and discuss the use of animal models for target identification and validation. The clinical relevance of animal models is discussed in terms of major limitations in cross-species comparisons, clinical trial design of drug candidates, and how clinical trial endpoints could be improved. The aim of this series of volumes on Animal and Translational Models for CNS Drug Discovery is to identify and provide common endpoints between species that can serve to inform both the clinic and the bench with the information needed to accelerate clinically-effective CNS drug discovery. This is the second volume in the three volume-set, Animal and Translational Models for CNS Drug Discovery 978-0-12-373861-5, which is also available for purchase individually. - Clinical, academic, government and industry perspectives fostering integrated communication between principle participants at all stages of the drug discovery process - Critical evaluation of animal and translational models improving transition from drug discovery and clinical development - Emphasis on what results mean to the overall drug discovery process - Exploration of issues in clinical trial design and conductance in each therapeutic area
Publisher: Academic Press
ISBN: 0080920381
Category : Medical
Languages : en
Pages : 413
Book Description
Neurological Disorders is written for researchers in both academia and the pharmaceutical industry who use animal models in research and development of drugs for neurological disorders such as neurofibromatosis, Alzheimer's disease, Parkinson's disease, Huntington disease, ALS, and the epilepsies. Neurological Disorders has introductory chapters expressing the view of the role and relevance of animal models for drug discovery and development for the treatment of psychiatric disorders from the perspective of (a) academic basic neuroscientific research, (b) applied pharmaceutical drug discovery and development, and (c) issues of clinical trial design and regulatory agencies limitations. Each volume examines the rationale, use, robustness and limitations of animal models in each therapeutic area covered and discuss the use of animal models for target identification and validation. The clinical relevance of animal models is discussed in terms of major limitations in cross-species comparisons, clinical trial design of drug candidates, and how clinical trial endpoints could be improved. The aim of this series of volumes on Animal and Translational Models for CNS Drug Discovery is to identify and provide common endpoints between species that can serve to inform both the clinic and the bench with the information needed to accelerate clinically-effective CNS drug discovery. This is the second volume in the three volume-set, Animal and Translational Models for CNS Drug Discovery 978-0-12-373861-5, which is also available for purchase individually. - Clinical, academic, government and industry perspectives fostering integrated communication between principle participants at all stages of the drug discovery process - Critical evaluation of animal and translational models improving transition from drug discovery and clinical development - Emphasis on what results mean to the overall drug discovery process - Exploration of issues in clinical trial design and conductance in each therapeutic area
Animal and Translational Models for CNS Drug Discovery: Psychiatric Disorders
Author: Robert A. McArthur
Publisher: Academic Press
ISBN: 008092039X
Category : Psychology
Languages : en
Pages : 528
Book Description
Psychiatric Disorders is written for researchers in both academia and the pharmaceutical industry who use animal models in research and development of drugs for psychiatric disorders such as anxiety, obsessive-compulsive disorder, depression, schizophrenia, bipolar disorder, ADHD, and autistic spectrum disorder. Psychiatric Disorders has introductory chapters expressing the view of the role and relevance of animal models for drug discovery and development for the treatment of psychiatric disorders from the perspective of (a) academic basic neuroscientific research, (b) applied pharmaceutical drug discovery and development, and (c) issues of clinical trial design and regulatory agencies limitations. Each volume examines the rationale, use, robustness and limitations of animal models in each therapeutic area covered and discuss the use of animal models for target identification and validation. The clinical relevance of animal models is discussed in terms of major limitations in cross-species comparisons, clinical trial design of drug candidates, and how clinical trial endpoints could be improved. The aim of this series of volumes on Animal and Translational Models for CNS Drug Discovery is to identify and provide common endpoints between species that can serve to inform both the clinic and the bench with the information needed to accelerate clinically-effective CNS drug discovery. This is the first volume in the three volume-set, Animal and Translational Models for CNS Drug Discovery 978-0-12-373861-5, and is also available for purchase individually. - Provides clinical, academic, government and industry perspectives fostering integrated communication between principle participants at all stages of the drug discovery process - Critical evaluation of animal and translational models improving transition from drug discovery and clinical development - Emphasizes what results mean to the overall drug discovery process - Explores issues in clinical trial design and conductance in each therapeutic area - Psychiatric Disorders is available for purchase individually.
Publisher: Academic Press
ISBN: 008092039X
Category : Psychology
Languages : en
Pages : 528
Book Description
Psychiatric Disorders is written for researchers in both academia and the pharmaceutical industry who use animal models in research and development of drugs for psychiatric disorders such as anxiety, obsessive-compulsive disorder, depression, schizophrenia, bipolar disorder, ADHD, and autistic spectrum disorder. Psychiatric Disorders has introductory chapters expressing the view of the role and relevance of animal models for drug discovery and development for the treatment of psychiatric disorders from the perspective of (a) academic basic neuroscientific research, (b) applied pharmaceutical drug discovery and development, and (c) issues of clinical trial design and regulatory agencies limitations. Each volume examines the rationale, use, robustness and limitations of animal models in each therapeutic area covered and discuss the use of animal models for target identification and validation. The clinical relevance of animal models is discussed in terms of major limitations in cross-species comparisons, clinical trial design of drug candidates, and how clinical trial endpoints could be improved. The aim of this series of volumes on Animal and Translational Models for CNS Drug Discovery is to identify and provide common endpoints between species that can serve to inform both the clinic and the bench with the information needed to accelerate clinically-effective CNS drug discovery. This is the first volume in the three volume-set, Animal and Translational Models for CNS Drug Discovery 978-0-12-373861-5, and is also available for purchase individually. - Provides clinical, academic, government and industry perspectives fostering integrated communication between principle participants at all stages of the drug discovery process - Critical evaluation of animal and translational models improving transition from drug discovery and clinical development - Emphasizes what results mean to the overall drug discovery process - Explores issues in clinical trial design and conductance in each therapeutic area - Psychiatric Disorders is available for purchase individually.
Human and Animal Models for Translational Research on Neurodegeneration: Challenges and Opportunities From South America
Author: Agustín Ibáñez
Publisher: Frontiers Media SA
ISBN: 2889454940
Category :
Languages : en
Pages : 217
Book Description
Neurodegenerative diseases are the most frequent cause of dementia, representing a burden for public health systems (especially in middle and middle-high income countries). Although most research on this issue is concentrated in first-world centers, growing efforts in South America are affording important breakthroughs. This emerging agenda poses new challenges for the region but also new opportunities for the field. This book aims to integrate the community of experts across the globe and the region, and to establish new challenges and developments for future investigation. We present research focused on neurodegenerative research in South America. We introduce studies assessing the interplay among genetic, neural, and behavioral dimensions of these diseases, as well as articles on vulnerability factors, comparisons of findings from various countries, and works promoting multicenter and collaborative networking. More generally, our book covers a broad scope of human-research approaches (behavioral assessment, neuroimaging, electromagnetic techniques, brain connectivity, peripheral measures), animal methodologies (genetics, epigenetics, proteomics, metabolomics, other molecular biology tools), species (all human and non-human animals, sporadic, and genetic versions), and article types (original research, review, and opinion papers). Through this wide-ranging proposal, we hope to introduce a fresh approach to the challenges and opportunities of research on neurodegeneration in South America.
Publisher: Frontiers Media SA
ISBN: 2889454940
Category :
Languages : en
Pages : 217
Book Description
Neurodegenerative diseases are the most frequent cause of dementia, representing a burden for public health systems (especially in middle and middle-high income countries). Although most research on this issue is concentrated in first-world centers, growing efforts in South America are affording important breakthroughs. This emerging agenda poses new challenges for the region but also new opportunities for the field. This book aims to integrate the community of experts across the globe and the region, and to establish new challenges and developments for future investigation. We present research focused on neurodegenerative research in South America. We introduce studies assessing the interplay among genetic, neural, and behavioral dimensions of these diseases, as well as articles on vulnerability factors, comparisons of findings from various countries, and works promoting multicenter and collaborative networking. More generally, our book covers a broad scope of human-research approaches (behavioral assessment, neuroimaging, electromagnetic techniques, brain connectivity, peripheral measures), animal methodologies (genetics, epigenetics, proteomics, metabolomics, other molecular biology tools), species (all human and non-human animals, sporadic, and genetic versions), and article types (original research, review, and opinion papers). Through this wide-ranging proposal, we hope to introduce a fresh approach to the challenges and opportunities of research on neurodegeneration in South America.
Blood-Brain Barrier in Drug Discovery
Author: Li Di
Publisher: John Wiley & Sons
ISBN: 1118788354
Category : Medical
Languages : en
Pages : 604
Book Description
Focused on central nervous system (CNS) drug discovery efforts, this book educates drug researchers about the blood-brain barrier (BBB) so they can affect important improvements in one of the most significant – and most challenging – areas of drug discovery. • Written by world experts to provide practical solutions to increase brain penetration or minimize CNS side-effects • Reviews state-of-the-art in silico, in vitro, and in vivo tools to assess brain penetration and advanced CNS drug delivery strategies • Covers BBB physiology, medicinal chemistry design principles, free drug hypothesis for the BBB, and transport mechanisms including passive diffusion, uptake/efflux transporters, and receptor-mediated processes • Highlights the advances in modelling BBB pharmacokinetics and dynamics relationships (PK/PD) and physiologically-based pharmacokinetics (PBPK) • Discusses case studies of successful CNS and non-CNS drugs, lessons learned and paths to the market
Publisher: John Wiley & Sons
ISBN: 1118788354
Category : Medical
Languages : en
Pages : 604
Book Description
Focused on central nervous system (CNS) drug discovery efforts, this book educates drug researchers about the blood-brain barrier (BBB) so they can affect important improvements in one of the most significant – and most challenging – areas of drug discovery. • Written by world experts to provide practical solutions to increase brain penetration or minimize CNS side-effects • Reviews state-of-the-art in silico, in vitro, and in vivo tools to assess brain penetration and advanced CNS drug delivery strategies • Covers BBB physiology, medicinal chemistry design principles, free drug hypothesis for the BBB, and transport mechanisms including passive diffusion, uptake/efflux transporters, and receptor-mediated processes • Highlights the advances in modelling BBB pharmacokinetics and dynamics relationships (PK/PD) and physiologically-based pharmacokinetics (PBPK) • Discusses case studies of successful CNS and non-CNS drugs, lessons learned and paths to the market
Encyclopedia of Psychopharmacology
Author: Ian Stolerman
Publisher: Springer Science & Business Media
ISBN: 3540686983
Category : Medical
Languages : en
Pages : 1433
Book Description
Here is a broad overview of the central topics and issues in psychopharmacology, biological psychiatry and behavioral neurosciences, with information about developments in the field, including novel drugs and technologies. The more than 2000 entries are written by leading experts in pharmacology and psychiatry and comprise in-depth essays, illustrated with full-color figures, and are presented in a lucid style.
Publisher: Springer Science & Business Media
ISBN: 3540686983
Category : Medical
Languages : en
Pages : 1433
Book Description
Here is a broad overview of the central topics and issues in psychopharmacology, biological psychiatry and behavioral neurosciences, with information about developments in the field, including novel drugs and technologies. The more than 2000 entries are written by leading experts in pharmacology and psychiatry and comprise in-depth essays, illustrated with full-color figures, and are presented in a lucid style.
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
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
Translational Medicine in CNS Drug Development
Author: George G. Nomikos
Publisher: Academic Press
ISBN: 0128031646
Category : Medical
Languages : en
Pages : 460
Book Description
Translational Medicine in CNS Drug Development, Volume 29, is the first book of its kind to offer a comprehensive overview of the latest developments in translational medicine and biomarker techniques. With extensive coverage on all aspects of biomarkers and personalized medicine, and numerous chapters devoted to the best strategies for developing drugs that target specific disorders, this book presents an essential reference for researchers in neuroscience and pharmacology who need the most up-to-date techniques for the successful development of drugs to treat central nervous system disorders. Despite increases in the number of individuals suffering from CNS-related disorders, the development and approval of drugs for their treatment have been hampered by inefficiencies in advancing compounds from preclinical discovery to the clinic. However, in the past decades, game-changing strides have been made in our understanding of the pathophysiology of CNS disorders and the relationship of drug exposure in plasma and CNS to pharmacodynamic measures in both animals and humans. - Includes comprehensive coverage of biomarker tools and the role of personalized medicine in CNS drug development - Discusses strategies for drug development for a full range of CNS indications, with particular attention to neuropsychiatric and neurocognitive disorders - Includes chapters written by international experts from industry and academia
Publisher: Academic Press
ISBN: 0128031646
Category : Medical
Languages : en
Pages : 460
Book Description
Translational Medicine in CNS Drug Development, Volume 29, is the first book of its kind to offer a comprehensive overview of the latest developments in translational medicine and biomarker techniques. With extensive coverage on all aspects of biomarkers and personalized medicine, and numerous chapters devoted to the best strategies for developing drugs that target specific disorders, this book presents an essential reference for researchers in neuroscience and pharmacology who need the most up-to-date techniques for the successful development of drugs to treat central nervous system disorders. Despite increases in the number of individuals suffering from CNS-related disorders, the development and approval of drugs for their treatment have been hampered by inefficiencies in advancing compounds from preclinical discovery to the clinic. However, in the past decades, game-changing strides have been made in our understanding of the pathophysiology of CNS disorders and the relationship of drug exposure in plasma and CNS to pharmacodynamic measures in both animals and humans. - Includes comprehensive coverage of biomarker tools and the role of personalized medicine in CNS drug development - Discusses strategies for drug development for a full range of CNS indications, with particular attention to neuropsychiatric and neurocognitive disorders - Includes chapters written by international experts from industry and academia
Guidance for the Description of Animal Research in Scientific Publications
Author: National Research Council
Publisher: National Academies Press
ISBN: 030921954X
Category : Science
Languages : en
Pages : 42
Book Description
The publication of research articles involving animal studies is central to many disciplines in science and biomedicine. Effective descriptions in such publications enable researchers to interpret the data, evaluate and replicate findings, and move the science forward. Analyses of published studies with research animals have demonstrated numerous deficiencies in the reporting of details in research methods for animal studies. Considerable variation in the amount of information required by scientific publications and reported by authors undermines this basic scientific principle and results in the unnecessary use of animals and other resources in failed efforts to reproduce study results. Guidance for the Description of Animal Research in Scientific Publications outlines the information that should be included in scientific papers regarding the animal studies to ensure that the study can be replicated. The report urges journal editors to actively promote effective and ethical research by encouraging the provision of sufficient information. Examples of this information include: conditions of housing and husbandry, genetic nomenclature, microbial status, detailed experimental manipulations, and handling and use of pharmaceuticals. Inclusion of this information will enable assessment and interpretation of research findings and advancement of knowledge based on reproducible results.
Publisher: National Academies Press
ISBN: 030921954X
Category : Science
Languages : en
Pages : 42
Book Description
The publication of research articles involving animal studies is central to many disciplines in science and biomedicine. Effective descriptions in such publications enable researchers to interpret the data, evaluate and replicate findings, and move the science forward. Analyses of published studies with research animals have demonstrated numerous deficiencies in the reporting of details in research methods for animal studies. Considerable variation in the amount of information required by scientific publications and reported by authors undermines this basic scientific principle and results in the unnecessary use of animals and other resources in failed efforts to reproduce study results. Guidance for the Description of Animal Research in Scientific Publications outlines the information that should be included in scientific papers regarding the animal studies to ensure that the study can be replicated. The report urges journal editors to actively promote effective and ethical research by encouraging the provision of sufficient information. Examples of this information include: conditions of housing and husbandry, genetic nomenclature, microbial status, detailed experimental manipulations, and handling and use of pharmaceuticals. Inclusion of this information will enable assessment and interpretation of research findings and advancement of knowledge based on reproducible results.
Nonclinical Safety Assessment
Author: William J. Brock
Publisher: John Wiley & Sons
ISBN: 0470745916
Category : Medical
Languages : en
Pages : 492
Book Description
Nonclinical Safety Assessment Nonclinical Safety Assessment A Guide to International Pharmaceutical Regulations 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.
Publisher: John Wiley & Sons
ISBN: 0470745916
Category : Medical
Languages : en
Pages : 492
Book Description
Nonclinical Safety Assessment Nonclinical Safety Assessment A Guide to International Pharmaceutical Regulations 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.