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Author: Peter Greaves
Publisher: Elsevier
ISBN: 0080471307
Category : Science
Languages : en
Pages : 962
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Book Description
This work covers effectively all aspects of drug-induced pathology that may be encountered within preclinical toxicity studies. It fills a gap in the pathology literature relating to the preclinical safety assessment of new medicines. It systematically describes, in one volume, both spontaneous and drug induced pathology on an organ by organ basis. Information relevant to understanding the nature of pathological changes in pre-clinical studies and assessment of their relevance to the clinical investigation of new drugs is also covered. Numerous colour photographs are included that highlight and embellish the histopathological features that are described. It also contains many pertinent references to both human and animal pathology forming an essential basis for the assessment of drug-induced pathology. NEW TO THE THIRD EDITION: * Covers drug induced pathology in preclinical (animal) studies and their relevance for patients or volunteers in clinical studies * General comments to each chapter about the relevance of pathological findings to humans * Provides essential information that can help decide the relevance of particular lesions for patients
Author: Peter Greaves
Publisher: Elsevier
ISBN: 0080471307
Category : Science
Languages : en
Pages : 962
Get Book Here
Book Description
This work covers effectively all aspects of drug-induced pathology that may be encountered within preclinical toxicity studies. It fills a gap in the pathology literature relating to the preclinical safety assessment of new medicines. It systematically describes, in one volume, both spontaneous and drug induced pathology on an organ by organ basis. Information relevant to understanding the nature of pathological changes in pre-clinical studies and assessment of their relevance to the clinical investigation of new drugs is also covered. Numerous colour photographs are included that highlight and embellish the histopathological features that are described. It also contains many pertinent references to both human and animal pathology forming an essential basis for the assessment of drug-induced pathology. NEW TO THE THIRD EDITION: * Covers drug induced pathology in preclinical (animal) studies and their relevance for patients or volunteers in clinical studies * General comments to each chapter about the relevance of pathological findings to humans * Provides essential information that can help decide the relevance of particular lesions for patients
Author: Peter Greaves
Publisher: Elsevier Publishing Company
ISBN:
Category : Medical
Languages : en
Pages : 844
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Book Description
Histopathological assessment of tissue sections is an important componant of many preclinical studies which are conducted to support the safety and clinical development of novel therapeutic agents for use in the treatment of human diseases. The drug discovery process, aided by modern biotechnology, is now capable of generating highly potent, pharmacologically active agents which can give rise to quite unusual constellations of tissue pathology. The complexity and the number of histopathological findings in individual studies indicate the need for lucididy in descriptions and conclusions. In the light of these and other difficulties, this text is aimed towards bringing together into one volume a description of histopathological changes which relate to toxicity testing of therapeutic agents in the usual test species: rat, mouse, dog and non-human primate. This book is an excellent starting point for the analysis of drug-induced findings in toxicity studies.
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: Wanda M. Haschek-Hock
Publisher: Academic Press
ISBN: 0323910521
Category : Medical
Languages : en
Pages : 694
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Book Description
Haschek and Rousseaux's Handbook of Toxicologic Pathology, recognized by many as the most authoritative single source of information in the field of toxicologic pathology, has been extensively updated to continue its comprehensive and timely coverage. The fourth edition has been expanded to five separate volumes due to an explosion of information in this field requiring new and updated chapters. Completely revised with a number of new chapters, Volume 2: Toxicologic Pathology in Safety Assessment is an essential part of the most authoritative reference on toxicologic pathology principles and techniques for assessing product safety and human risk. Volume 2 describes the integration of product-induced structural and functional changes in tissues and the interpretation of their biological implications. Completely revised with many new chapters, Volume 2 of the Fourth Edition covers product safety assessment from many angles including current and emerging issues in toxicologic pathology for many product classes. Volume 2 of the Handbook of Toxicologic Pathology is a key resource for pathologists, toxicologists, research scientists, and regulators who use toxicologic pathology methods to study and make decisions on product safety. Previous chapters on such topics as drug discovery and development, toxicity and carcinogenicity testing, report preparation, and risk assessment and communication have undergone extensive revision that includes in-depth discussion of new developments in the field New chapters consider fundamental attributes for additional product classes including protein therapeutics, nucleic acid pharmaceutical agents, gene therapy and gene editing, stem cell and other cell therapies, vaccines, agricultural and bulk chemicals, and assigning adversity Chapters dealing with product-specific practices address pathology and regulatory issues Chapters offer high-quality and up-to-date content in a trusted work written by the collaborative efforts of many leading international subject matter experts Hundreds of full-color images and diagrams are featured in both the print and electronic versions of this book to illustrate classic examples and highlight difficult concepts
Author: Ali S. Faqi
Publisher: Elsevier
ISBN: 0323984622
Category : Medical
Languages : en
Pages : 1074
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Book Description
A Comprehensive Guide to Toxicology in Nonclinical Drug Development, Third Edition is a valuable reference providing a complete understanding of all aspects of nonclinical toxicology in pharmaceutical research. This updated edition has been expanded and re-developed covering a wide-range of toxicological issues in small molecules and biologics. Topics include ADME in drug discovery, pharmacokinetics, toxicokinetics, formulations, and genetic toxicology testing. The book has been thoroughly updated throughout to reflect the latest scientific advances and includes new information on antiviral drugs, anti-diabetic drugs, immunotherapy, and a discussion on post-pandemic drug development challenges and opportunities. This is an essential and practical resource for all toxicologists involved in nonclinical testing in industry, academic, and regulatory settings. Provides updated, unique content not covered in one comprehensive resource, including chapters on stem cells, antiviral drugs, anti-diabetic drugs, and immunotherapy Includes 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 expectations associated with working in nonclinical toxicology
Author: Elizabeth Fiona McInnes
Publisher: Elsevier Health Sciences
ISBN: 0702049247
Category : Medical
Languages : en
Pages : 256
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Book Description
Background Lesions in Laboratory Animals will be an invaluable aid to pathologists needing to recognize background and incidental lesions while examining slides taken from laboratory animals in acute and chronic toxicity studies, or while examining exotic species in a diagnostic laboratory. It gives clear descriptions and illustrations of the majority of background lesions likely to be encountered. Many of the lesions covered are unusual and can be mistaken for treatment-related findings in preclinical toxicity studies. The Atlas has been prepared with contributions from experienced toxicological pathologists who are specialists in each of the laboratory animal species covered and who have published extensively in these areas. over 600 high-definition, top-quality color photographs of background lesions found in rats, mice, dogs, minipigs, non-human primates, hamsters, guinea pigs and rabbits a separate chapter on lesions in the reproductive systems of all laboratory animals written by Dr Dianne Creasy, a world expert on testicular lesions in laboratory animals a chapter on common artifacts that may be observed in histological glass slides extensive references to each lesion described aging lesions encountered in all laboratory animal species, particularly in rats in mice which are used for carcinogenicity studies
Author: Pritam S. Sahota
Publisher: CRC Press
ISBN: 1439872120
Category : Medical
Languages : en
Pages : 987
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Book Description
As drug development shifts over time to address unmet medical needs and more targeted therapies are developed, previously unseen pharmacological or off-target effects may occur in treatment. Designed to provide practical information for the bench toxicologic pathologist working in pharmaceutical drug research, Toxicologic Pathology: Nonclinical Saf
Author: Dick van Velzen
Publisher:
ISBN:
Category : Drugs
Languages : en
Pages : 178
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Book Description
Author: Shayne Cox Gad
Publisher: John Wiley & Sons
ISBN: 1119097401
Category : Medical
Languages : en
Pages : 918
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Book Description
This practical guide presents a road map for safety assessment as an integral part of the development of new drugs and therapeutics. Helps readers solve scientific, technical, and regulatory issues in preclinical safety assessment and early clinical drug development Explains scientific and philosophical bases for evaluation of specific concerns – including local tissue tolerance, target organ toxicity and carcinogenicity, developmental toxicity, immunogenicity, and immunotoxicity Covers the development of new small and large molecules, generics, 505(b)(2) route NDAs, and biosimilars Revises material to reflect new drug products (small synthetic, large proteins and cells, and tissues), harmonized global and national regulations, and new technologies for safety evaluation Adds almost 20% new and thoroughly updates existing content from the last edition
Author: Keith Green
Publisher: Springer Science & Business Media
ISBN: 1461518873
Category : Medical
Languages : en
Pages : 365
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Book Description
On behalf of the editorial board and the organizing committee of the 4th congress of the International Society of Ocular Toxicology (I SOT), held in AnnecyNeyrier du Lac, France, October 9 -13, 1994, we are pleased to present to the ocular toxicology community this indexed volume of our congress proceedings. The 4th congress was designed primarily to facilitate and update the knowledge in ocular electrophysiology and ocular pharmacokinetics, in both the clinical and preclinical aspects. The outcome of this 4th congress, established in this volume, is a useful contribution to the meth odology in both fields and will hopefully assist in the evaluation and interpretation of ocular findings recorded in animal studies on drugs and other chemicals, in order to protect human health. Undoubtedly, work on the mechanisms of ocular toxicology in the process of pharmaceutical development must continue and these proceedings, embodying the presented papers, will add to the data base. The editors, the congress organizing committee and the members of the International Society of Ocular Toxicology thank the speakers who gave their time, knowledge, and expertise to assist us in this project. The following manuscripts contain the main substance of each of the platform presentations and, in some cases, much more. Moreover, our thanks go to all the participants coming from a range of background- regulatory, academic and industrial -for their attention and excellent contributions during the discussion.
