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Author:   Gregory Argentieri ,  Pritam S. Sahota (Global ToxPath, LLC, USA) ,  Robert H. Spaet (RSPathologics, LLC, USA) ,  Zbigniew W. Wojcinski
Publisher:   Taylor & Francis Ltd
Imprint:   CRC Press
Weight:   2.170kg
ISBN:  

9780367364670

ISBN 10:   0367364670
Pages:   430
Publication Date:   25 March 2024
Audience:   Professional and scholarly ,  Professional & Vocational
Format:   Hardback
Publisher's Status:   Active
Availability:   Not yet available  
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Table of Contents

1. Introduction to Toxicologic Pathology Robert R. Maronpot and Abraham Nyska 2. Overviews of Drug Development and Nonclinical Safety; Interactions with Toxicologic Pathologist; Regulatory Aspects Jim Fikes, John Kapeghian and Zbigniew W. Wojcinski 3. Gastrointestinal System Thomas Nolte and Judit E. Markovits 4. Liver, Gallbladder and Exocrine Pancreas Russell C. Cattley, James A. Popp, and Steven L. Vonderfecht 5. Respiratory System Tom McKevitt 6. Urinary System Kendall S. Frazier and John Curtis Seely 7. Hematopoietic System Stephan Schmidtbauer and Hans Harleman 8. The Lymphoid System Steven Laing 9. Bone, Muscle, and Tooth Matthias Rinke and Christine Ruehl-Fehlert 10. Cardiovascular System Roger H. Alison and Vasanthi Mowat 11. Endocrine System Thomas J. Rosol 12. Male Reproductive System Catherine Picut and Quinci Plumlee 13. Female Reproductive System & Mammary Gland Daniel G. Rudmann 14. Integumentary System Maurice Cary, Kelly Diegel and Lars Mecklenburg 15. Nervous System Ian Taylor, Ingrid D. Pardo and Alok K. Sharma 16. Special Senses JoAnn J. L. Schuh

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Author Information

Dr. Pritam S Sahota studied for his Veterinary Medicine (BVSc) and Veterinary Pathology (MVSc and PhD) degrees at Punjab Agricultural University in India (1976). 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 (1976-86) with increasing responsibilities as Toxicologic Pathologist, Senior Toxicologic Pathologist, and Scientific Director. 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, Scheduling and Quality Control systems. He continued to work primarily in this position with increasing responsibilities in Ciba-Geigy and then Novartis Pharmaceuticals (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 International Project Team Representative for several 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 successfully led following Global Preclinical Safety initiatives at Novartis: Patient Centricity, Cardiotoxicity, Ocular Toxicity, and evaluation of rodent carcinogenicity potential based on short-term toxicity and genotoxicity studies to minimize delays in regulatory submissions. Dr. Sahota also held an adjunct academic appointment of Assistant Professor in the University of Medicine and Dentistry of New Jersey, Newark, NJ for approximately 8 years. In 2013 and 2018, he co-edited as Lead Editor the First and Second Editions of the book entitled “Toxicologic Pathology, Nonclinical Safety Assessment” (CRC Press). In 2019, Dr. Sahota co-edited as Lead Editor “The Illustrated Dictionary of Toxicologic Pathology and Safety Science” (CRC Press), which was considered one of the 100 Best Pharmaceutical Books of All Time (Book Authority). Finally, Dr. Sahota as Lead-Editor, published Current Topics in Nonclinical Drug Development Volume-1 (2020) and Road to Greatness (2022). Robert H. Spaet obtained his BS and MS degrees (Zoology) from Eastern Illinois University. He began his career as a Sr. Research Technician at the Franklin McClean Memorial Research Institute, Univ. of Chicago, before joining GD Searle Labs as a Parapathologist. He became a Research and Teaching Assistant at the Univ. of Oklahoma Health Sciences Center and completed coursework towards a PhD in Anatomic and Experimental Pathology before joining Ciba-Geigy Pharmaceuticals in June 1977 as a Scientist II in Pathology, Preclinical Safety. He also completed his oral and written exams for a PhD in Anatomic Pathology at Univ. of Medicine and Dentistry of New Jersey (UMDNJ) while working for CIBA. Robert’s core training and expertise lies in toxicologic pathology within the framework of drug safety assessment, and he is accredited by the International Academy of Toxicologic Pathology. He has also had full time experience as a Study Director and is certified as a Diplomate, American Board of Toxicology. Robert has written many scientific papers in the field of toxicology and toxicologic pathology and holds full membership in several prominent professional societies including the Society of Toxicologic Pathology (US and Europe), Society of Toxicology, American College of Toxicology, and is a member of the Roundtable of Toxicology Consultants. He has 45+ years’ experience in toxicologic pathology and regulatory toxicology. During his tenure with CIBA and Novartis, he held a series of positions of increasing responsibility to eventually become Director, Translational Sciences, Novartis Institutes for Biomedical Research, Preclinical Safety/Department of Pathology. His professional experience was broadened as an Exchange Scientist with CIBA in Basel, Switzerland (’87, ‘88). Beginning in 1986 he served as an International Project Team Preclinical Safety representative for several compounds in development, including two successfully marketed (blockbuster) 2nd and 3rd generation bisphosphonates developed to ameliorate bone loss, Aredia® and Zometa®. In this capacity he authored extensive safety summaries in support of IND/NDA/CTX drug submissions and represented the company as a preclinical safety expert before regulatory agencies (FDA and EMEA). For these successes, he was awarded The President’s Distinguished Scientist Citation (’95) and The President’s Distinguished Fellow Award (’02). Among other professional activities, he participated in the team teaching of Pathology as Adjunct Professor in the School of Allied Health Sciences at the UMDNJ (‘99 – ‘06). Post-retirement, Robert continues to remain active in toxicologic pathology and non-clinical safety having established a consultancy RSPathologics, LLC in 2013. He recently co-edited The Illustrated Dictionary of Toxicologic Pathology and Safety Science (CRC Press) which was considered the first of its kind published work in the non-clinical safety community. Post-publication, the book ranked #5 among top 100 toxicology books of all time by Bookauthority https://bookauthority.org/about. Robert is currently co-editing another work entitled Toxicologic Pathology: An Atlas. He has been a member of several high-profile groups including the Society of Toxicologic Pathology’s Science and Regulatory Policy Committee, the STP Membership, Fundraising and Tox/Path Forum Committees, and the European Society of Toxicologic Pathology Committee on the impact of AI on Toxicologic Pathology. Zbigniew W. Wojcinski is President of Toxicology & Pathology Consulting, LLC, in Hillsborough, NC and has over 35 years’ experience in pharmaceutical drug development. Dr. Wojcinski received his undergraduate degree (B.Sc.) in Zoology from the University of Toronto and his D.V.M. and D.V.Sc. (Pathology) degrees from the Ontario Veterinary College, University of Guelph. He is a certified Diplomate of the American Board of Toxicology and a Diplomate of the American College of Veterinary Pathologists. He is also recognized as a Specialist in Veterinary Pathology by the Canadian Veterinary Medical Association and a Fellow of the International Academy of Toxicologic Pathology. Dr. Wojcinski gained experience in drug development and toxicologic pathology during his 22-year tenure with Parke-Davis\Warner-Lambert and Pfizer Global Research and Development and then 3½ years with Fulcrum Pharma Developments, Inc. In 2011, he founded Drug Development Pathology Services, LLC in Ann Arbor, MI and subsequently grew the organization into Drug Development Preclinical Services, LLC to provide toxicology, pathology, and drug metabolism and pharmacokinetic services. Dr. Wojcinski has extensive experience as a Study Director, Study Pathologist, and Review Pathologist for numerous acute and repeated dose toxicity studies, including carcinogenicity studies. Throughout his career, he has managed successful cross-functional drug development teams in CNS, Metabolic Diseases, and Dermatology therapeutic areas. Dr. Wojcinski has been directly involved in the preparation of pre-IND documents, Nonclinical Safety Assessments for IND/IMPD/NDA/MAA, Investigator’s Brochures, and labeling (USPI, SmPC) negotiations. He has had numerous interactions with regulatory agencies in the United States, Europe, Canada, and Australia for compounds at various stages of development. He has also provided pathology consultation and histopathology peer review on several projects in various therapeutic areas, including respiratory infections, dermatitis, oncology, and ophthalmic disease and served on Pathology Working Groups. Dr. Wojcinski is a full member of numerous professional societies including the American College of Veterinary Pathologists, Society of Toxicologic Pathologists, Society of Toxicology, American College of Toxicology, American Veterinary Medical Association, Canadian Veterinary Medical Association, Canadian Association of Veterinary Pathologists, Regulatory Affairs Professionals Society, and Roundtable of Toxicology Consultants. He has served as President of the Dermal Toxicity Specialty Section of the Society of Toxicology, an Associate Editor for the Society of Toxicologic Pathology, Editor of The Scope for the Society of Toxicologic Pathology, and Chair of the Society of Toxicologic Pathology Recruitment Subcommittee. Dr. Wojcinski has lectured at the Ontario Veterinary College and the University of Maryland and authored/co-authored numerous scientific reports, manuscripts, and book chapters. He is Co-Editor for the following books: “The Illustrated Dictionary of Toxicologic Pathology & Safety Science” (published in 2019); “Current Topics in Nonclinical Drug Development, Volume 1” (published in 2021); “Guideposts for Veterinary Professionals” (published in 2021); “Road to Greatness” (published in 2022); “Toxicologic Pathology: An Atlas” (due to be published in 2023); “Current Topics in Nonclinical Drug Development, Volume 2” (due to be published in 2023); and “Toxicologic Pathology, Nonclinical Safety Assessment, 3rd Edition” (due to be published in 2024). Gregory Argentieri received BS and MS Degrees in Biology from William Paterson University. He was Senior Electron Microscopy and Digital Imaging Laboratory Manager with 33 years of proven team management skills and diverse technical experience supporting pharmaceutical research and development in the medical and industrial fields at Sandoz, and Novartis Pharmaceuticals Corp. E. Hanover NJ. He is an Electron Microscopist certified by the Microscopy Society of America, with extensive experience in light and electron microscopy, image analysis, and other related techniques in medical, biological, and material sciences. Throughout his long career, he has been recognized by senior managers and peers for quality work in a high-pressure environment. Mr. Argentieri also taught Graduate and Undergraduate scanning and Transmission electron microscopy / lecture and lab as an adjunct professor at William Paterson College. He was a contributor to New York Microscopy society newsletter. Mr. Argentieri’s ongoing contributions include serving as Illustrations Editor for the following books: The Illustrated Dictionary of Toxicologic Pathology & Safety Science” (published in 2019); “Current Topics in Nonclinical Drug Development, Volume 1” (published in 2021); “Toxicologic Pathology: An Atlas” (target publication 2023); and “Current Topics in Nonclinical Drug Development, Volume 2” (target publication 2023).

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