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The Illustrated Dictionary of Toxicologic Pathology and Safety Science

Langue : Anglais

Coordonnateurs : Sahota Pritam S., Spaet Robert H., Bentley Philip, Wojcinski Zbigniew

Couverture de l’ouvrage The Illustrated Dictionary of Toxicologic Pathology and Safety Science

There has been a growing interest in toxicologic pathology, especially as related to its impact on the safety assessment of pharmaceuticals and chemicals, and in drug development. Thus, there is a growing need for an Illustrated Dictionary of Toxicology Pathology and Safety Science (IDTP) that this dictionary aims to fill. The language of toxicologic pathology may be less familiar to a broad range of safety scientists, especially those involved in the safety evaluation of pharmaceuticals and chemicals. The IDTP format provides the brevity and clarity that the user is not likely to receive in a textbook, even if adequately indexed. With the inclusion of descriptions for terms used in toxicology, drug metabolism/pharmacokinetics, and regulatory science, the scope of the IDTP is considerably broadened and decidedly unique in its appeal to all safety scientists.

With over 800 photos and illustrations to provide visual context,* an important aim of the IDTP is to present pathological changes as reference examples for terminology, nomenclature, and term descriptions for the entry entry-level as well as seasoned toxicologic pathologist. It will also aid students and non-pathology specialists such as study directors, senior toxicology report reviewers, scientific management of contract research organizations, regulatory agencies, and drug development companies to better understand the biological significance of tissue changes. The IDTP provides a single reference volume for these users to further their understanding and appreciation of biologically significant pathology findings.

The IDTP consists of four major areas:

1. A-Z Dictionary of Pathology encompassing all organ systems, together with relevant non-pathology terms supported by references in "For Further Reading" sections.

2. Appendix 1: An Overviews of Drug Development, Nonclinical Safety & Toxicologic Pathology, and Important/Special Topics.

3. Appendix 2: Diagnostic Criteria of for Proliferative Proliferative Lesions in Rodents (Rat and Mouse) and Selected Non-Rodent Laboratory Species containing illustrations with detailed references and links to source material.

4) Appendix 3: Mini-Atlas of Organ System Anatomy and Histology to help re-acquaint the non-pathologist safety scientist with many normal anatomical structures.

The editors and contributing scientists (board-certified veterinary pathologists, board-certified toxicologists, allied health safety scientists, health regulatory representatives) have experience from bench-level pathology and toxicology to managing global preclinical safety units in leading pharmaceutical companies. They have considerable experience mentoring pharmaceutical industry project team members, interacting with industry clinicians and representatives of decision-making bodies within the industry, as well as with global health authorities, such as the FDA and EMA. These activities convinced them of the necessity for and usefulness of the IDTP. As experts in their field, they have undertaken the hard work of writing and compiling the information, making the IDTP an exceptional, go-to reference.

*Illustrations Editor: Gregory Argentieri

The Illustrated Dictionary of Toxicologic Pathology (A-Z). Subject Matter: ADME. Bone, Muscle, and Tooth. Cardiovascular System. Endocrine Glands. Gastrointestinal Tract. General Pathology. Genotoxicity. Hematopoietic System. Liver, Gallbladder, and Exocrine Pancreas. Lymphoid System. Nervous System. Quality Assurance. Reproductive System and Mammary Gland. Reproductive Toxicology. Respiratory System. Safety Pharmacology. Skin. Special Senses. Toxicology. Urinary System. Appendix 1: Overview of Drug Development, Nonclinical Safety & Toxicologic Pathology, and Important/Special Topics. Appendix 2: Diagnostic Criteria for Selected Proliferative Lesions in Rodents (Rat and Mouse) and Selected Non-Rodent Laboratory Species. Appendix 3: Mini-Atlas of Organ System Anatomy and Histology. For Further Reading by Organ System.

Professional Reference

Dr. Pritam S. Sahota studied for his Veterinary Medicine (BVSc) and Veterinary Pathology (MSc and PhD) degrees at Punjab Agricultural University in India. He is a Diplomate of the American Board of Toxicology. After completing his PhD, he immigrated to the USA in 1976 and worked for Dawson Research Corporation in Orlando, Florida for 10 years with increasing responsibilities as Toxicologic Pathologist, Senior Toxicologic Pathologist, and Scientific Director. As Scientific Director, he was overall responsible for the Departments of Pathology and Toxicology in this contract research organization (CRO) that was involved in the safety evaluation of drugs and chemicals. While working briefly for Dynamac Corporation in Research Triangle Park, NC (1986-87), Dr. Sahota conducted retrospective scientific audits on 23 NTP carcinogenicity studies and participated in discussions with the representatives of NTP, FDA and EPA to summarize the results of scientific audits of approximately 200 carcinogenicity studies. In 1987, Dr. Sahota joined Ciba-Geigy Pharmaceuticals in Summit, NJ as Head/Manager of Pathologists and helped establish Pathology Peer Review and Quality Control systems. He continued to work primarily in this position with increasing responsibilities in Ciba-Geigy and then Novartis (resulting from Ciba/Sandoz merger in 1997) up to 2000, when he became Head of Pathology (Director→ Executive Director: 2000-12, East Hanover, NJ). In addition to his pathology responsibilities, Dr. Sahota also served as an International Project Team Representative for a number of marketed drugs including an antihypertensive blockbuster, Diovan, where he successfully defended company position with the FDA and various International Regulatory Authorities. During 2010-12, he also successfully led following Global Preclinical Safety initiatives at Novartis: Patient Centricity (Patient in the Lab), Cardiotoxicity, Ocular Toxicity, and evaluation of rodent carcinogenicity potential b