Hello. Sign In
Standards Store

Toxicologic Pathology: Nonclinical Safety Assessment

2013 Edition, April 9, 2013

Complete Document

Detail Summary

Active, Most Current

Additional Comments:
ISBN: 978-1-4398-7210-9
Price (USD)
Add to Cart

Product Details:

  • Revision: 2013 Edition, April 9, 2013
  • Published Date: April 9, 2013
  • Status: Active, Most Current
  • Document Language: English
  • Published By: CRC Press (CRC)
  • Page Count: 987
  • ANSI Approved: No
  • DoD Adopted: No

Description / Abstract:


Toxicologic Pathology: Nonclinical Safety Assessment is the result of careful planning and diligence by the editors and authors. When entering the field of toxicologic pathology related to drug development, the authors recognize the currently limited and scattered resources available to assist the toxicologic pathologist, despite the best of basic diagnostic training and committed mentorship. The editors have each served as mentors to toxicologic pathologists entering the arena of drug development over the years and were struck by these shortcomings. Therefore, the current text has been specifically designed to assist the students/residents and toxicologic pathologists in the early phase of their careers by serving as a resource that can effectively be used as a ready reference next to the microscope. Of course, even the most experienced pathologist in drug development has not "seen it all," as areas of drug emphasis shift over time and more targeted therapies are developed, resulting in previously unseen, exaggerated pharmacologic or off-target effects. Since the initiation of this book, toxicologists have expressed great interest in such a resource to better appreciate the gravity of pathological lesions and processes described by the pathologist in toxicology reports and to promote a much more fruitful dialog with pathologists toward a common understanding.

Toward these ends, the editors have organized this volume into two major sections, each composed of multiple chapters. Since it is critical that the toxicologic pathologist has a basic understanding of areas beyond diagnostic pathology to function effectively in an ever-increasing, integrated approach to drug development, eight concept chapters are included. While numerous concept chapters are possible, the current book includes those eight topics that have been judiciously selected to orient the pathologist in areas that are important for effective interaction with other pathologists as well as the many nonpathologists involved in drug development. The second major section is composed of 13 chapters oriented by organ system. While this approach is generally used in pathology texts, the limitation of presenting material on a multiorgan pathologic entity (e.g., phospholipidosis) presented across several chapters is recognized. In such instances, information in various sections should be identifiable from the index.

Any book of this nature is only as good as the authors who prepare the specific sections, thus their selection was given very careful consideration. They were obviously chosen for their knowledge, expertise, and focused interest on a topic. While multiple potential authors may be able to develop a solid treatise on a topic based on literature review, we also know that extensive knowledge and expertise based on the experience of working through toxicologic pathology issues that often do not appear in the literature add a critical dimension. Therefore, the book was designed to present important information, both published and unpublished, as gained through personal experience, so this knowledge can be used by others to improve the quality of drug safety evaluation and, as importantly, to expedite and improve the efficiency of the process. The editors and the future readers are indebted to the authors for sharing such personal knowledge in addition to organizing and summarizing the latest information available in the literature.

While extensive care has been taken by the authors to identify the most important topics and effectively address them within the constraints of this book, there will inevitably be topics that have been missed or have not been given enough space, and there will certainly be unforeseen topics that will need to be added in the future. Therefore, the editors solicit input from readers as they use the text. The goal is to continually upgrade and update the book at reasonable intervals so it can be of even greater value to future users. Creators and users of future revisions will surely benefit from the contributions made by the readers and users of this initial edition of Toxicologic Pathology: Nonclinical Safety Assessment.