《毒理病理学：非临床安全性评估 第二版》(EPUB)

English | ISBN: 149874530X | 2018 | EPUB | 1244 pages | 19 MB

Pritam S. Sahota, James A. Popp, Jerry F. Hardisty, Chirukandath Gopinath, Page R. Bouchard, "Toxicologic Pathology: Nonclinical Safety Assessment, 2nd Edition"

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.

Pritam S. Sahota, James A. Popp, Jerry F. Hardisty, Chirukandath Gopinatah Page R. Bouchard，《毒理病理学：非临床安全性评估，第2版》

在首版取得成功之后，这本书旨在为从事药物研发与开发的毒理病理学家提供实用且及时的信息。大部分内容（器官系统章节）将详细描述药物研发中观察到的组织病理学病变。此外，还将提供帮助病理学家确定病灶来源及其对人类风险相关性的信息。

《毒理病理学：非临床安全性评估，第二版》包含两个新的概念章节。第一新章节处理细胞疗法、基因疗法和基因表达沉默疗法等独特治疗方式的评价方法。尽管这些仍然是尚在发展中的一类治疗方法，但在过去五年中已有相当的经验积累。第二个新章节则涵盖了医疗器械的非临床安全性评估的内容，这是首版未曾专门讨论过的主题。

其他概念章节也进行了更新，并涵盖了许多重要话题，包括药物研发概述；非临床安全性评估的基本原则；毒理病理学简介；毒理病理学、临床病理学、毒动药代动力学和药物开发毒基因组学的使用技术；以及自发性病变。

每个器官系统章节提供了有关各器官系统的病理特征、鉴别诊断及毒性反应解读的具体信息。这些章节不仅对实验室病理学家具有重要价值，也适用于与病理学家互动并对药物研发过程中的临床试验毒理学家和项目团队代表负责的毒理学专家。

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