Toxicologic Pathology
Langue : anglais
Edité par CRC Press, 2024
- Livre relié
- Neuf

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- Titre
- Toxicologic Pathology
- Auteur
- Gregory Argentieri
- Éditeur
- CRC Press
- Année de publication
- 2024
- État de l'article
- New
- Reliure
- HRD
- Langue
- anglais
- ISBN à 10 chiffres
- 0367364670
- ISBN à 13 chiffres
- 9780367364670
- Illustrateur
- Argentieri, Gregory
- Poids de l'article
- 1 255 grammes
There has been an enormous growth of interest in the field of toxicologic pathology and particularly on its impact on nonclinical safety assessment in global drug development and in the environment. Toxicologic pathologists play an important role in detecting test article-related adverse effects by characterizing morphologic changes in animal tissues and/or body fluids under prescribed study conditions or less clearly defined conditions in the environment and in the interpretation of these findings relative to human risk. In fact, pathology evaluation is often the single most important decision-making factor in nonclinical safety assessments as 80% of drug candidate attrition has been attributed to pathology findings in toxicity studies. There are currently no primers or basic overviews covering the field of toxicologic pathology, whereas there are at least several basic books that cover the sister field of toxicology.
Toxicologic Pathology: A Primer is a practical, easy-to-use reference designed to contain core information provided by board-certified veterinary pathologists, all experts in the field. The Primer contains the basic, underlying principles of toxicologic pathology at the introductory level; thus it will be valuable to the veterinary pathology student who may be considering a career in the field as well as a companion to the seasoned toxicologic pathologist who wants a succinct refresher. The Primer is arranged as chapters presenting each major organ system preceded by an overview chapter covering the field of toxicologic pathology followed by a “concept” chapter describing the role of toxicologic pathology in drug development. Photomicrographs and illustrations provide visual context.
The organ system chapters provide histopathologic descriptions of lesions observed in toxicity studies of test articles in drug development and testing of chemicals that may negatively impact the environment. Each organ system chapter provides additional information related to a particular lesion to aid the reader in better understanding its toxicologic significance relative to human risk.
Each organ system chapter contains:
- A brief introduction
- A succinct description of the anatomy and physiology of the system
- Descriptions of the most important pathological lesions
- Differential diagnoses
- Biological consequences, pathogenesis, and/or mechanism of lesion formation
- Associated clinical pathology correlates
Nonclinical safety scientists such as study directors, non-pathology-oriented contributing scientists such as senior toxicology report reviewers, scientific management of Contract Research Organizations (CROs), and students should find the Primer useful in helping them understand the fundamentals of toxicologic pathology.
« Synopsis » peut appartenir à une autre édition de cet ouvrage.
À propos de l’auteur
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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Vendeur AbeBooks depuis 11 juin 1999
Frais d'expédition de Royaume-Uni vers Etats-Unis
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We are committed to protecting the privacy and security of personal data. This policy tells you how we will collect and use your personal data, and what you should expect in respect of the personal information about you that we have collected.
We are PBShop.co.uk Limited (registered in England & Wales with Company No: 9366362). Our registered office is at Swatton Barn, Badbury, Swindon, SN4 0EU, United Kingdom.
The person with responsibility for our data protection compliance is the Managing Director and they can be contacted via email at help@pbshop.store.
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Lawfulness, fairness and transparency;
Purpose limitation;
Data minimisation;
Accuracy;
Storage limitation;
Integrity and confidentiality.
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a copy of your personal data;
that inaccurate data is rectified; and
that your personal data is, in certain circumstances, erased or restricted.
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COLLECTION, USE AND DISCLOSURE OF PERSONAL DATA
We collect and process data for the following reasons:
personal data collected and created in relation to our selling books and other items; and
personal data relating to our people (which means those people working for our company, or providing services to us, or potentially working or providing services to us, including employees, consultants, temporary or casual workers and contractors).
All of our people are required to abide by our Privacy Policy when handling personal data, and are provided with appropriate data protection training. Any breach of data protection will be taken seriously, and may result in disciplinary action.
Selling books and other items
COLLECTION:
We will collect personal information which may include names, addresses and other information for our customers. This will be done for the management of the commercial relationship with our customers.
We may collect this personal data from you directly, and also from third parties, including publicly available third party sources. Additional personal data will be collected as it is created by or supplied to us in the course of anything we do for you.
USE:
We will use the personal data in the course of making sales and to comply with requirements that we are required to undertake.
We will only use your personal data when the law allows us to. Most commonly, we will use your personal data in the following circumstances:
in performance of a contract (the agreement to sell books and other items); and/or
compliance with a legal obligation; and/or
vital interests of the data subject; and/or
where it is necessary for our legitimate interests (or those of a third party) and your interests and fundamental rights do not override those interests.
We may also use your personal data in the following situations, which are likely to be far less common:
where we need to protect your interests (or someone else’s interests);
where it is needed in the public interest or for official purposes.
DISCLOSURE:
We may share personal data with third parties as is necessary in the sale of books and other items, including to third party providers who deliver services to support the operation of our company.
In respect of all disclosures of personal data, we will only share the personal information which is necessary for the particular purpose for which it is provided, or where we have another legitimate interest in doing so, and we will ensure that the personal data is appropriately protected.
RETENTION PERIOD:
We will keep personal data only for as long as is necessary to fulfil the purposes for which we collected it, including for the purposes of satisfying any legal, accounting or reporting requirements. Normally, our retention period for personal data collected for this purpose is a minimum of 6 years after the end of the period that we are selling books and other items.
Our people
COLLECTION:
We will collect names, addresses, contact details, education and employment history, identity and other background checks (which may include appropriate criminal and financial checks and confirmation of the right to work in the UK), marital status and information on next of kin and dependents, financial information (such as bank details and NI numbers), date of birth, gender, a copy of your passport and driving licence, performance information and compensation history, recruitment information (including references), salary, benefits, pension and annual leave information, disciplinary and grievance information, photographs, information about your use of our information and communications systems and CCTV footage or other information obtained through electronic means.
We may collect and use special categories of personal data as required in the carrying out of obligations and exercising specific rights of us or the data subject in the field of employment. This may include information relating to matters such as health, racial origin, religious belief and offences or alleged offences.
Personal data may be collected from you during the selection process (for example via your application form and CV) and during your employment (including holiday forms, expense claims, performance reviews, any disciplinary or grievance processes), or from third parties, including referees, health service providers, background check providers.
USE:
Personal data of our people will be used for HR administration and management, both in respect of the selection of people to work for us (including suitability, eligibility and/or fitness to work), and those who do work for us, to include learning and development, disciplinary and security (of people, offices and data) requirements, providing and liaising with benefits providers, business management and planning (including accounting and auditing), paying you and dealing with tax and NI deductions, assessing and deciding on salary reviews and compensation, conducting performance reviews and managing performance, dealing with legal disputes involving you or others, preventing fraud, monitoring your use of our information and communications systems, ensuring compliance with our policies, and equal opportunities monitoring.
We will only use your personal data when the law allows us to. Most commonly, we will use your personal data in the following circumstances:
In performance of a contract with you; and/or
compliance with a legal obligation; and/or
vital interests of the data subject; and/or
where it is necessary for our legitimate interests (or those of a third party) and your interests and fundamental rights do not override those interests.
We may also use your personal data in the following situations, which are likely to be less common:
where we need to protect your interests (or someone else’s interests);
where it is needed in the public interest or for official purposes.
In respect of all disclosures of personal data, we will only share the personal information which is necessary for the particular purpose for which it is provided, or where we have another legitimate interest in doing so, and we will ensure that the personal data is appropriately protected.
In respect of special categories of personal data, we may process this in the following circumstances:
in limited circumstances with your explicit written consent; and/or
where we need to carry out our legal obligations and in line with our policies; and/or
where it is needed in the public interest (such as for equal opportunities monitoring or in relation to our occupational pension scheme), and in line with our policies; and/or
where it is needed to assess your working capacity on health grounds, subject to appropriate confidentiality safeguards.
Less commonly, we may process this type of information where it is needed in relation to legal claims or where it is needed to protect your (or someone else’s) interests and you are not capable of giving your consent, or where you have already made the information public. We may also process such information about our people (or former people) in the course of our legitimate business activities with the appropriate safeguards.
The special categories of personal data may be used in the following ways:
in relation to leaves of absence, to comply with employment and other laws;
in relation to your physical or mental health, or disability status, to ensure your health and safety in the workplace and to assess your fitness to work, to monitor, manage and administer benefits and absences;
in relation to your race, national or ethnic origin, religious, philosophical or moral beliefs, or your sexual life or sexual orientation, to ensure meaningful equal opportunity monitoring and reporting.
DISCLOSURE:
Personal data may be transferred to service providers who support the operation of our business (such as payroll service providers), to other third parties reasonably necessary in the conduct of our business (including insurers, professional advisors, regulators). These third parties may be acting as processor, or controller of personal data in their own right.
In respect of all disclosures of personal data, we will only share the personal information which is necessary for the particular purpose for which it is provided, or where we have another legitimate interest in doing so, and we will ensure that the personal data is appropriately protected.
RETENTION PERIOD:
We will keep personal data only for as long as is necessary to fulfil the purposes for which we collected it, including for the purposes of satisfying any legal, accounting or reporting requirements. We will normally keep personal data of applicants who we do not employ for six months after we receive it.
We will keep personal data of employees throughout your employment and normally for a minimum of six years after your employment ends.
Changes to your personal data
It is very important that the personal information that we hold about you is accurate and current. Please tell us if your personal information changes during your relationship with us.
Data Security
We have put in place measures to prevent your personal data from being accidentally lost, used or accessed in an unauthorised way, altered or disclosed. In addition, we limit access to your personal data to those of our people and other third parties who have a business need to know. They will only process your personal data on our instructions and where they have agreed to treat the information confidentially and to keep it secure. We have put in place procedures to deal with any suspected data security breach and will notify you and the ICO of a suspected breach where we are legally required to do so.
Where we store your personal data
We principally store data, both electronically and on file, at our office.
Personal data may be transferred outside of the EEA by processors acting on our behalf. For transfers to countries not considered adequate by the EC, we will ensure that personal data is adequately protected, as required by the GDPR. This would include by use of the Standard Contractual Clauses adopted by the EC to protect personal data.
Your rights
Under certain circumstances, you have the right by law to request:
access to your personal data. This enables you to ask to receive a copy of the personal data that we hold about you and to check that we are lawfully processing it.
correction of the personal data that we hold about you.
erasure of your personal data.
object to processing of your personal data where we are relying on our legitimate interest and there is something about your particular situation which makes you want to object to processing on this ground. You also have the right to object where we are processing your personal information for direct marketing purposes.
restriction of processing of your personal data.
transfer of your personal data to another party.
Links from our website
Our website may, from time to time, contain links to and from the websites of third parties that we permit to make such links. If you follow a link to any of these websites, please note that these websites have their own privacy policies and that we do not accept any responsibility or liability for these policies. We recommend that you check these policies before you submit any personal data to these websites.
CHANGES TO THIS PRIVACY POLICY
Any changes we may make to our privacy policy in the future will be posted on our website, so please ensure that you are viewing the correct version.
Please contact us if you have any questions, comments or requests regarding this Privacy Policy.
Last amended May 2021.