Toxicologic Pathology: An Atlas
暫譯: 毒理病理學：圖譜

在過去幾十年中，毒理病理學這一安全科學的重要領域的興趣呈指數增長，特別是在其對全球藥物開發和環境保護的非臨床安全影響方面。選定的非增生性和增生性病變的光學顯微照片示例是補充毒理病理學教科書中書面敘述所必需的。《毒理病理學：圖譜》滿足了這一需求，並由該領域的頂尖專家提供意見。這本書將成為一個有價值的參考資料，不僅對毒理病理學家有用，還對各種非臨床安全科學家，特別是在製藥和生技產業中的專業人士有幫助。

本書提供了毒理病理學中常見發現的插圖和描述（即超過1100個光學顯微照片示例）。這些插圖為該領域中常用的術語和描述提供了視覺背景。這些插圖及其附帶的描述由在毒理病理學、毒理學和藥物開發方面的知名專家編輯和審核。該圖譜旨在實用、易於使用，並希望成為一個可靠的“首選”參考資料，對學生和非科學家（例如，擔任動物照護和使用委員會的個體）來說，作為理解術語和可視化毒理病理學家所描述的組織變化的關鍵單一來源。

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 ten 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, North Carolina (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, New Jersey, 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 the 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 the company's position with the FDA and various International Regulatory Authorities. During 2010-12, he successfully led the 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 as an Assistant Professor in the University of Medicine and Dentistry of New Jersey, Newark, New Jersey, for approximately eight 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).

Zbigniew W. Wojcinski is President of Toxicology & Pathology Consulting, LLC, in Hillsborough, North Carolina, and has over 40 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 31/2 years with Fulcrum Pharma Developments, Inc. In 2011, he founded Drug Development Pathology Services, LLC in Ann Arbor, Michigan, 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 US, 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, ophthalmic disease, women's health, and rare diseases, 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, Chair of the Society of Toxicologic Pathology Recruitment Subcommittee, Editor of The Scope for the Society of Toxicologic Pathology, member of the Society of Toxicologic Pathology International Harmonization of Nomenclature and Diagnostic Criteria (INHAND) committee, Editor for the Toxicologic Pathology Forum of the Society of Toxicologic Pathology, and member of the Editorial Board for the Society of Toxicologic Pathology journal. 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: A Primer" (published in 2024); "Current Topics in Nonclinical Drug Development, Volume 2" (published in 2024); "Toxicologic Pathology, Nonclinical Safety Assessment, 3rd Edition" (published in 2025); and "Current Topics in Nonclinical Drug Development, Volume 3" (due to be published in 2025).

Robert H. Spaet's expertise lies in toxicologic pathology in drug safety assessment, with 45+ years' experience in the field. He is accredited by the International Academy of Toxicologic Pathology and is certified as a Diplomate, American Board of Toxicology (1989-2025). He obtained his BS and MS degrees in Zoology from Eastern Illinois University and began his career as a Sr. Research Technician at the Franklin McClean Memorial Research Institute, University of Chicago, before joining GD Searle Laboratories as a Parapathologist. He became a Research/Teaching Assistant at the University of Oklahoma Health Sciences Center and completed coursework toward a PhD in Anatomic and Experimental Pathology before joining Ciba-Geigy Pharmaceuticals as a Scientist II in Pathology, Preclinical Safety. He also completed his oral and written exams for a PhD in Anatomic Pathology at the University of Medicine and Dentistry of New Jersey while working for CIBA. 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 [Silver Member/Silver & Bronze Most Valuable Contributor] and Europe), Society of Toxicology, American College of Toxicology, and is a member of the Roundtable of Toxicology Consultants. While at CIBA/Novartis, he held a series of positions of increasing responsibility to eventually become Director, Translational Sciences, Novartis Institutes for Biomedical Research, Dept of Pathology. His professional experience was broadened as an Exchange Pathologist with CIBA in Basel, Switzerland (1987,1988). He served as 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(R) and Zometa(R). 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 the FDA and EMEA. For these successes, he was awarded The President's Distinguished Scientist Citation and The President's Distinguished Fellow Award. Among other professional activities, he participated in the team teaching of Toxicologic Pathology as an Adjunct Professor in the School of Allied Health Sciences at the UMDNJ from 1999 to 2006. Post-retirement, Robert remains active in toxicologic pathology and nonclinical safety, having established a consultancy, RSPathologics, LLC, in 2013. He co-edited The Illustrated Dictionary of Toxicologic Pathology and Safety Science (May '19, CRC Press), which was considered the first of its kind published work in the non-clinical safety community. Within a year and a half of publication, the book ranked #5 among the top 100 pharmaceutical texts of all time by BookAuthority https: // bookauthority. org/ about. He recently completed co-editing Toxicologic Pathology: A Primer (March '24, CRC Press). 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 (Co-Chair) and Tox/Path Forum (Chair) Committees, and the European Society of Toxicologic Pathology Committee on the role/impact of AI and Deep Learning in Toxicologic Pathology.

Dr. Jerry F. Hardisty was the Chief Executive Officer of Experimental Pathology Laboratories, Inc. (EPL(R)). He currently serves as a Senior Pathologist and consultant at EPL. He graduated from Iowa State University College of Veterinary Medicine and received his pathology training in the U.S. Army Preceptorship Program. He joined EPL as a staff pathologist in 1976. He has been a Diplomate of the American College of Veterinary Pathologists since 1976 and in 2015 was recognized as a Distinguished Member of the ACVP. Dr. Hardisty served as an Adjunct Assistant Professor with the North Carolina State University College of Veterinary Medicine. In 2005, he was awarded the Stange Award for Meritorious Service by the College of Veterinary Medicine at Iowa State University. Dr. Hardisty has worked with the NCI/NTP Carcinogenesis Testing Program closely for over 30 years. He has participated in the publication and presentation of significant results of the NCI/NTP Pathology Quality Assessment Program and of several specific carcinogenesis bioassay tests. He has coauthored several publications in experimental pathology, pathology quality assessment, and pathology peer review. He has served on the Editorial Board for Toxicologic Sciences, Toxicologic Pathology, and Experimental and Toxicologic Pathology. He specializes in the conduct of Pathology Peer Review of subchronic and carcinogenicity nonclinical toxicology studies. He was a co-editor for the First and Second Editions of the book entitled "Toxicologic Pathology, Nonclinical Safety Assessment" (CRC Press). He has organized and chaired Pathology Working Groups and Scientific Advisory Panels in the US, Japan, and Europe. Dr. Hardisty has been active in the Society of Toxicologic Pathologists (STP) as member of Executive Committee (1994-1998), Standard Systematized Nomenclature and Diagnostic Criteria Committee (SSNDC) (1984-2000), liaison with the American College of Toxicology (1998-2000), as President-Elect (199-1999), President (1999-2000) and as Past-President (2001-2002). He also served as the chair of the STP nominating and fundraising committees. In 2011, he received the Society of Toxicologic Pathology Achievement Award. He is a member of the International Academy of Toxicologic Pathologists (IATP) and served as the North American Director of the IATP. While President of the STP, he was involved in starting the ACT/STP Pathology for non-Pathologist course and the annual NTP pathology symposium presented at the annual American College of Toxicology (ACT) meeting. He has worked as an ad hoc member of the program committee for several years and is a member of the 2010 ACT program committee. In 2010, he received the American College of Toxicology Service Award. He was elected to the ACT council in 2011 and has served as chair of the Education Committee. Dr. Hardisty continues to support interaction between the ACT and STP through CE courses and symposia at the annual meetings of both organizations.

Gregory Argentieri received a BS and an MS degree 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, New Jersey. 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 the 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).

Dr. Pritam S. Sahota 在印度的旁遮普農業大學獲得獸醫學（BVSc）和獸醫病理學（MVSc 和 PhD）學位（1976年）。他是美國毒理學委員會的專家會員。完成博士學位後，他於1976年移民至美國，並在佛羅里達州奧蘭多的道森研究公司工作了十年（1976-1986），擔任毒理病理學家、高級毒理病理學家及科學主任等職位，負責逐漸增加。在1986年至1987年間，他短暫地在北卡羅來納州的Dynamac公司工作，進行了23項NTP致癌性研究的回顧性科學審核，並參與與NTP、FDA和EPA代表的討論，總結約200項致癌性研究的科學審核結果。1987年，Dr. Sahota 加入新澤西州薩米特的Ciba-Geigy製藥公司，擔任病理學部門的負責人/經理，協助建立病理學同行評審、排程和質量控制系統。他在Ciba-Geigy及隨後的Novartis製藥公司（因1997年Ciba/Sandoz合併而成立）持續擔任此職位，並在2000年成為病理學部門的負責人（主任→執行主任：2000-2012，東漢諾佛，NJ）。除了病理學的責任外，Dr. Sahota 還擔任多種上市藥物的國際項目團隊代表，包括一種抗高血壓的暢銷藥Diovan，他成功地為公司在FDA及各國際監管機構的立場辯護。在2010年至2012年間，他成功領導了Novartis的以下全球前臨床安全倡議：以病人為中心、心臟毒性、眼毒性，以及基於短期毒性和基因毒性研究評估啮齒動物的致癌潛力，以最小化監管提交的延遲。Dr. Sahota 還在新澤西州紐瓦克的醫藥與牙科大學擔任助理教授的兼任學術職位約八年。在2013年和2018年，他作為主編共同編輯了名為《毒理病理學：非臨床安全評估》（CRC Press）的第一版和第二版。2019年，Dr. Sahota 作為主編共同編輯了《毒理病理學與安全科學插圖詞典》（CRC Press），該書被認為是有史以來100本最佳藥學書籍之一（Book Authority）。最後，Dr. Sahota 作為主編出版了《非臨床藥物開發當前主題第一卷》（2020）和《通往偉大之路》（2022）。

Zbigniew W. Wojcinski 是位於北卡羅來納州希爾斯堡的毒理學與病理學諮詢公司（Toxicology & Pathology Consulting, LLC）的總裁，擁有超過40年的藥物開發經驗。Dr. Wojcinski 在多倫多大學獲得動物學學士學位（B.Sc.），並在圭爾夫大學的安大略獸醫學院獲得D.V.M.和D.V.Sc.（病理學）學位。他是美國毒理學委員會的認證專家會員，也是美國獸醫病理學會的專家會員。他還被加拿大獸醫醫學協會認可為獸醫病理學專家，並是國際毒理病理學學院的院士。Dr. Wojcinski 在Parke-Davis\Warner-Lambert和Pfizer全球研究與開發的22年任期內獲得了藥物開發和毒理病理學的經驗，隨後在Fulcrum Pharma Developments, Inc.工作了3年半。2011年，他在密歇根州安娜堡創立了藥物開發病理學服務公司（Drug Development Pathology Services, LLC），並隨後將該組織發展為藥物開發前臨床服務公司（Drug Development Preclinical Services, LLC），提供毒理學、病理學及藥物代謝和藥物動力學服務。Dr. Wojcinski 在多項急性和重複劑量毒性研究中擔任研究主任、研究病理學家和審查病理學家的角色，包括致癌性研究。在他的職業生涯中，他管理了成功的跨功能藥物開發團隊，涵蓋中樞神經系統、代謝疾病和皮膚科等治療領域。Dr. Wojcinski 直接參與了IND文件的準備、IND/IMPD/NDA/MAA的非臨床安全評估、研究者手冊和標籤（USPI, SmPC）談判。他與美國、歐洲、加拿大和澳大利亞的監管機構進行了多次互動，涉及不同開發階段的化合物。他還在多個治療領域提供病理學諮詢和組織病理學同行評審，包括呼吸道感染、皮膚炎、腫瘤學、眼科疾病、女性健康和罕見疾病，並參加病理學工作小組。Dr. Wojcinski 是多個專業學會的正式成員，包括美國獸醫病理學會、毒理病理學會、毒理學會、美國毒理學會、美國獸醫醫學協會、加拿大獸醫醫學協會、加拿大獸醫病理學會、監管事務專業人員協會和毒理學顧問圓桌會議。他曾擔任毒理學會皮膚毒性專業小組的主席、毒理病理學會招聘小組的主席、《毒理病理學會範疇》的編輯、毒理病理學會國際命名和診斷標準協調小組（INHAND）委員會的成員、《毒理病理學會論壇》的編輯，以及《毒理病理學會期刊》的編輯委員會成員。Dr. Wojcinski 在安大略獸醫學院和馬里蘭大學講授課程，並撰寫/共同撰寫了多篇科學報告、手稿和書籍章節。他是以下書籍的共同編輯：'毒理病理學與安全科學插圖詞典'（2019年出版）；'非臨床藥物開發當前主題第一卷'（2021年出版）；'獸醫專業指導'（2021年出版）；'通往偉大之路'（2022年出版）；'毒理病理學：入門'（2024年出版）；'非臨床藥物開發當前主題第二卷'（2024年出版）；'毒理病理學：非臨床安全評估，第三版'（2025年出版）；以及'非臨床藥物開發當前主題第三卷'（預計於2025年出版）。

Robert H. Spaet 的專業領域是藥物安全評估中的毒理病理學，擁有超過45年的經驗。他獲得國際毒理病理學學院的認證，並於1989年至2025年期間獲得美國毒理學委員會的專家會員資格。他在伊利諾伊東部大學獲得動物學的學士和碩士學位，並在芝加哥大學的富蘭克林·麥克林紀念研究所擔任高級研究技術員，之後加入GD Searle實驗室擔任病理學助理。他成為奧克拉荷馬州健康科學中心的研究/教學助理，並在Ciba-Geigy製藥公司擔任病理學科學家II，專注於前臨床安全。Robert在CIBA工作期間，完成了新澤西醫藥與牙科大學的解剖病理學博士口試和書面考試。他在毒理學和毒理病理學領域撰寫了多篇科學論文，並在多個知名專業學會中擁有正式會員資格，包括毒理病理學會（美國[銀會員/銀與銅最有價值貢獻者]和歐洲）、毒理學會、美國毒理學會，並是毒理學顧問圓桌會議的成員。在CIBA/Novartis工作期間，他擔任了一系列職位，最終成為Novartis生物醫學研究所病理學部的轉化科學主任。他的專業經驗在1987年和1988年作為CIBA在瑞士巴塞爾的交流病理學家時得到了擴展。他擔任多個開發中化合物的國際項目團隊前臨床安全代表，包括兩種成功上市的（暢銷）第二代和第三代雙磷酸鹽，旨在改善骨質流失的Aredia(R)和Zometa(R)。在此角色中，他撰寫了大量安全摘要，以支持IND/NDA/CTX藥物提交，並作為前臨床安全專家代表公司在FDA和EMEA面前發言。因這些成功，他獲得了總統傑出科學家獎和總統傑出研究員獎。在其他專業活動中，他參與了1999年至2006年間在UMDNJ的健康科學學院作為兼任教授教授毒理病理學的團隊教學。退休後，Robert 仍然活躍於毒理病理學和非臨床安全領域，於2013年成立了RSPathologics, LLC顧問公司。他共同編輯了《毒理病理學與安全科學插圖詞典》（2019年5月，CRC Press），該書被認為是非臨床安全社區中首部此類出版物。在出版一年半內，該書在BookAuthority中排名前100本藥學書籍的第5位。他最近完成了《毒理病理學：入門》（2024年3月，CRC Press）的共同編輯工作。他是多個高端小組的成員，包括毒理病理學會的科學與監管政策委員會、STP會員、籌款（聯合主席）和毒理/病理論壇（主席）委員會，以及歐洲毒理病理學會關於AI和深度學習在毒理病理學中角色/影響的委員會。

Dr. Jerry F. Hardisty 曾是實驗病理學實驗室公司（EPL(R)）的首席執行官。他目前擔任EPL的高級病理學家和顧問。他畢業於愛荷華州立大學獸醫學院，並在美國陸軍的指導計劃中接受病理學訓練。他於1976年加入EPL擔任職員病理學家。自1976年以來，他一直是美國獸醫病理學會的專家會員，並於2015年被認定為ACVP的傑出成員。Dr. Hardisty 曾擔任北卡羅來納州立大學獸醫學院的兼任助理教授。2005年，他獲得愛荷華州立大學獸醫學院頒發的斯坦吉獎，以表彰其卓越服務。Dr. Hardisty 與NCI/NTP致癌測試計劃密切合作超過30年。他參與了NCI/NTP病理質量評估計劃的重大結果的出版和展示，以及幾項特定的致癌生物測試。他共同撰寫了多篇有關實驗病理學、病理質量評估和病理同行評審的出版物。他曾擔任《毒理科學》、《毒理病理學》和《實驗與毒理病理學》的編輯委員會成員。他專注於對亞急性和致癌性非臨床毒理學研究的病理同行評審。他是名為《毒理病理學：非臨床安全評估》（CRC Press）的第一版和第二版的共同編輯。他在美國、日本和歐洲組織和主持了病理學工作小組和科學諮詢小組。Dr. Hardisty 在毒理病理學會（STP）中活躍，曾擔任執行委員會成員（1994-1998）、標準系統...