Current Topics in Nonclinical Drug Development
Language: English
Published by CRC Press, 2020
Series: Book 1 of 1 - Current Topics in Nonclinical Drug Development
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Dieser Artikel ist ein Print on Demand Artikel und wird nach Ihrer Bestellung fuer Sie gedruckt. Pritam S. Sahota, Global ToxPath LLC, Kennewick, Washington, USA,has extensive experience in toxicologic pathology and drug developmentwithin the framework of nonclinical safety assessment of pharmaceuticals.Dr. Sahota was previously.
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- Title
- Current Topics in Nonclinical Drug Development
- Publisher
- CRC Press
- Publication year
- 2020
- Condition
- New
- Binding
- Hardcover
- Language
- English
- ISBN 10
- 0367136279
- ISBN 13
- 9780367136277
- Series
- Book 1 of 1: Current Topics in Nonclinical Drug Development
The inaugural volume in the Current Topics in Nonclinical Drug Development Series explores the critical issues and current topics in nonclinical drug development. This first volume covers individual topics and strategies in drug development from compound characterization to drug registration. Written by a variety of experts in the field, recent and rapid advances in technologies and associated changes in regulatory guidance are discussed.
Additional features include:
- Deals with day-to-day issues in study design, evaluation of findings, and presentation of data.
- Explains new approaches in the development of medical devices.
- Includes dedicated chapters on the use of bioinformatics in drug development.
- Addresses strategies for photosafety testing of drugs.
Current Topics in Nonclinical Drug Development, Volume I will aid toxicologists, toxicologic pathologists, consultants, regulators, Study Directors, and nonclinical scientists dealing with day-to-day issues in study design, evaluation of findings, and presentation of data. In addition, the book will be a valuable reference for academicians and graduate students pursuing research related to nonclinical drug development.
"Synopsis" may belong to another edition of this title.
About the Author
Pritam S. Sahota, Global ToxPath LLC, Kennewick, Washington, USA,
has extensive experience in toxicologic pathology and drug development
within the framework of nonclinical safety assessment of pharmaceuticals.
Dr. Sahota was previously Executive Director and Head of Pathology,
Preclinical Safety, at Novartis Pharmaceuticals, East Hanover, New Jersey.
He obtained his veterinary medicine (BVSc) and veterinary pathology
degrees (MSc and PhD) from Punjab Agricultural University, India. He
is a diplomate of the American Board of Toxicology. After receiving his
PhD in 1976, he started working as a toxicologic pathologist at Dawson
Research Corporation (DRC), Orlando, Florida, a contract research organization
involved in the preclinical safety evaluation of drugs and chemicals.
At DRC, he received increasing responsibility over the next 10 years
(toxicologic pathologist, senior toxicologic pathologist, and scientific director).
As a scientific director, he was responsible for the scientific aspects of
pathology as well as toxicology at DRC. While working briefly for Dynamac
Corporation, Research Triangle Park, North Carolina (1986–1987), he conducted
retrospective scientific audits of 23 NTP carcinogenicity studies and
participated in discussions with the representatives of NTP, FDA, and EPA
to review the results of scientific audits of over 200 NTP carcinogenicity
studies. In 1987, he joined Ciba-Geigy Pharmaceuticals in New Jersey as
Head/Manager of pathologists in preclinical safety and was also responsible
for establishing pathology peer review, quality control, and scheduling
systems. He continued to work primarily in this position with increasing
responsibilities at Ciba-Geigy and then Novartis Pharmaceuticals (after
Ciba-Sandoz merger in 1997) to become director and eventually Executive
Director and Head of pathology. During this time, he also served as an international
project team representative for a number of successfully marketed
CNS, immunosuppression, diabetes, and cardiovascular drugs, including
Diovan, which eventually became one of the 15 all-time, best-selling prescription
drugs. He also held an adjunct academic appointment of Assistant
Professor at the University of Medicine and Dentistry, New Jersey, for
8 years. He successfully led several global preclinical safety initiatives at
Novartis, including patient centricity, review of best practices in cardiotoxicity
and ocular toxicity, as well as evaluation of rodent carcinogenicity
potential based on noncarcinogenicity data to minimize future delays in
regulatory submissions. Since retirement from Novartis Pharmaceuticals
in 2012, Dr Sahota has been the President of Global ToxPath LLC located
in Kennewick, WA, USA (Toxicologic Pathology Consultancy). As lead editor,
he published the following books with CRC Press/Taylor & Francis:
(1) Toxicologic Pathology: Nonclinical Safety Assessment (First Edition,
2013); (2) Toxicologic Pathology: Nonclinical Safety Assessment (Second
Edition, 2018); (3) The Illustrated Dictionary of Toxicologic Pathology and
Safety Science (First Edition, 2019); (4) CT-NCDD: Volume 1 (due to be
published in 2020); (5) Road to Greatness (due to be published in 2020);
(6) Toxicologic Pathology: A Primer (due to be published in 2021); and
(7) Toxicologic Pathology: An Atlas (due to be published in 2022).
Philip Bentley is a principal consultant at Toxicodynamix International
LLC. He studied biochemistry at the University of Hull, UK, graduating
with a BSc in 1970 and a PhD in 1974. He had postdoctoral fellowships at
the Universities of Basel, Switzerland, and Mainz, Germany. His postdoctoral
research centered upon formation and inactivation of reactive metabolites
and the enzymes involved in the metabolism of foreign compounds. In
1979, he joined the Investigative Toxicology group (known as Cell Biology)
in the Toxicology Department of Ciba-Geigy, Basel, Switzerland, and
remained with the company, later Novartis, until 2014. In these 35 years,
he held various management positions in Europe and the United States
with responsibility for Investigative Toxicology; Drug Metabolism; Drug
Metabolism and Toxicology; Preclinical Safety Europe; Drug Metabolism
and Pharmacokinetics; Toxicology/Pathology United States; Preclinical
Safety United States; and Global Preclinical Safety. In these positions, he
contributed to the registration of more than 45 marketed drug products and
the preparation of several hundred investigational new drugs (INDs). He
has vast experience in the areas of drug metabolism and disposition, toxicology/
pathology, genetic toxicology, pharmacokinetics/toxicokinetics,
and all aspects of investigative toxicology. He is well grounded in biochemistry,
cell biology, molecular biology, and pharmacology with the ability to
integrate data from the different preclinical disciplines to enable translation
to determine the clinical relevance of the findings. He is very familiar with
global drug registration requirements and working on global projects.
He has authored more than 80 scientific publications, has lectured
in toxicology at the University of Basel for more than 30 years, and is a
past president of the European Society of Biochemical Pharmacology
and the Swiss Society of Toxicology. He was a member of the PhRMA/IQ
Preclinical Leadership (DruSafe) Committee for 16 years, a member of the
advisory board of the PSTC Biomarker consortium, and a member of the
expert working group for revision of the ICH S2 guidance on genotoxicity
testing and the PhRMA expert group on genotoxic impurities.
Zbigniew W. Wojcinski is president of Toxicology & Pathology Consulting,
LLC, in Ann Arbor, Michigan, and has over 30 years of experience in drug
development. Dr. Wojcinski received his undergraduate degree (BSc) in
Zoology from the University of Toronto and his DVM and DVSc (Pathology)
degrees from the Ontario Veterinary College, University of Guelph. He is a
board-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. 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. As
therapeutic area leader for Dermatology at Pfizer, Dr Wojcinski was responsible
for development and implementation of the safety and risk management
strategies for, what was then, a new therapeutic area. He has also
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 in CNS, anti-infective, and dermatology
therapeutic areas. Dr Wojcinski 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, ophthalmic
disease, anticancer, and hypolipidemics, 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/coauthored numerous scientific
reports, manuscripts, and book chapters. Recently, he was coeditor
for The Illustrated Dictionary of Toxicologic Pathology & Safety Science (First
Edition, published in 2019) and is currently contributing editor for Road to
Greatness (due to be published in 2020); coeditor for Toxicologic Pathology:
A Primer (due to be published in 2021); and coeditor for Toxicologic Pathology:
An Atlas (due to be published in 2022).
"About the title" may belong to another edition of this title.
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Engberdingdamm 27
Greven, Germany 48268
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Standard Business Terms and customer information/ data protection declaration
Revocation right for consumers
(A ‘consumer’ is any natural person who concludes a legal transaction which, to an overwhelming extent, cannot be attributed to either his commercial or independent professional activities.)
Instructions for revocation
Revocation right
You have the right to revoke this contract within one month without specifying any reasons.
The revocation period is one month with effect from the day,
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on which you or a third party nominated by you, which is not the carrier, had taken possession of the products, provided you had ordered one or more products within the scope of a standard order and this/these product/products is/are delivered uniformly;
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In order to exercise your revocation right, you must inform us (Moluna GmbH, Engberdingdamm 27, 48268 Greven, Telephone number: 02571/5 69 89 33, Fax number: 02571/5 69 89 30, E-Mail address: abe@moluna.de) of your decision to revoke this contract by means of a clear declaration (e.g. a letter sent via post, fax or email). You can use the enclosed specimen revocation form for this, which however is not mandatory.
In order to safeguard the revocation period, it is sufficient that you send the notification about the exercise of the revocation right before the expiry of the revocation period.
Consequences of the revocation
If you revoke this contract, we shall repay all the payments, which we received from you, including the delivery costs (with the exception of additional costs, which arise from that fact that you selected a form of delivery other than the most reasonable standard delivery offered by us), immediately and at the latest within 14 days from the day on which we received the notification about the revocation of this contract from you. We use the same means of payment, which you had originally used during the original transaction, for this repayment unless expressly agreed otherwise with you; you will not be charged any fees owing to this repayment.
We can refuse the repayment until the products are returned to us or until you have furnished evidence that you have sent the products back to us, depending on whichever is earlier.
You must return or transfer the products to us immediately and, in any case, at the latest within 14 days with effect from the day on which you inform us of the revocation of this contract. The deadline is maintained if you send the products before the expiry of the 14 day deadline.
You bear the direct costs for returning the products.
You must pay for any depreciation of the products only if this depreciation can be attributed to any handling with you that was not necessary for checking the condition, features and functionality of the products.
Criteria for exclusion or expiry
The revocation right is not available for contracts
for delivery of products, which are not prefabricated and for whose manufacturing an individual selection or stipulation by the consumer is important or which are clearly tailored to the personal requirements of the consumer;
for delivery of products, which can spoil quickly or whose use-by date would be exceeded quickly;
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The revocation right expires prematurely in case of contracts
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Specimen - revocation form
(If you wish to revoke the contract, please fill up this form and send it back to us.)
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To Moluna GmbH, Münsterstr. 105, 48268 Greven, Fax number: 02571/5 69 89 30, Email address: abe@moluna.de :
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I/we () herewith revoke the contract concluded by me/ us () regarding the purchase of the following products ()/
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Ordered on ()/ received on ()
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Name of the consumer(s)
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Address of the consumer(s)
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I. Standard business terms
§ 1 Basic provisions
(1) The following terms and conditions of business apply for all contracts concluded with us as the supplier (Moluna GmbH) via the websites AbeBooks and/or ZVAB. Unless otherwise agreed, the inclusion of your own terms and conditions is explicitly rejected.
(2) A ‘consumer’ in the sense of the following regulations is every natural person who concludes a legal transaction which, to an overwhelming extent, cannot be attributed to either his commercial or independent professional activities. The term ‘businessman’ refers to every natural person, legal person or legally responsible partnership that concludes a legal transaction in pursuance of his/its independent professional or commercial activity.
§ 2 Conclusion of the contract
(1) The subject-matter of the contract is the selling of products .
(2) If an article is placed by us with AbeBooks or ZVAB, the activation of the page on AbeBooks or ZVAB shall involve the binding offer to conclude a contract under the terms and conditions contained in the article page.
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The products intended for purchase are moved to the "shopping cart". You can select the "Shopping Cart" using the appropriate buttons on the navigation bar and make changes there at any time.
After calling up the “Checkout” page and entering the required personal data and payment and shipping conditions, all order information is then displayed again on the order summary page.
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By clicking the “Buy now” button to submit the order, you declare your legally binding acceptance of the order which makes the contract effective.
(4) The execution of the order and the sending of all the details necessitated by the conclusion of the contract take place via e-mail, in a partially-automated manner. Consequently, you have to ensure that the e-mail address that you have deposited with us is the correct one, and that the receipt of the respective e-mails is guaranteed. In particular, you have to ensure that the respective e-mails are not blocked by a SPAM filter.
§ 3 Right of retention, reservation of proprietary rights
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a) We retain ownership of the goods until all the claims arising from the ongoing business relationship have been settled in full. The goods subject to retention of title may not be pledged or transferred by way of security before ownership of the said goods changes hands.
b) You can re-sell the goods within the framework of an orderly transaction. In this regard, you hereby cede all the claims amounting to the magnitude of the billing amount that accrue to you as a result of the re-selling operation to us, and we accept the cession. Furthermore, you are authorised to collect the claim in question. However, insofar as you do not discharge your payment obligations in an orderly fashion, we reserve the right to collect the claim ourselves.
c) In a situation involving the combination and amalgamation of the goods subject to retention of title, we acquire co-ownership of the newly-formed item. This co-ownership corresponds to the ratio that exists between the invoice value of the goods subject to retention of title and the other processed items at the time of processing.
d) If you make a request of this nature, we shall be obligated to release the securities that are due to us, to the extent that the realisable value of our securities exceeds the claim to be secured by more than 10%. We are responsible for selecting the securities to be released.
§ 4 Warranty
(1) The statutory warranty rights are applicable.
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(3) If a characteristic of the goods deviates from the objective requirements, the deviation shall only be deemed to be agreed if you were informed of the same by us before submitting the contractual declaration and the deviation was expressly and separately agreed between the contracting parties.
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Insofar as you are an entrepreneur, the following shall apply in deviation from the above warranty provisions:
a) Only our own specifications and the manufacturer's product description shall be deemed agreed as the quality of the goods, but not other advertising, public promotions and statements by the manufacturer.
b) In the event of defects, we shall, at our discretion, provide warranty by rectification of the defect or subsequent delivery. If the rectification of defects fails, you may, at your option, demand a reduction in price or withdraw from the contract. The rectification of defects shall be deemed to have failed after a second unsuccessful attempt, unless the nature of the goods or the defect or other circumstances indicate otherwise. In the event of rectification of defects, we shall not be obliged to bear the increased costs arising from the transport of the goods to a place other than the place of performance, unless such transport is in accordance with the intended use of the goods.
c) The warranty period shall be one year from delivery of the goods. The shortening of the period shall not apply
- for culpable damage attributable to us arising from injury to life, limb or health and for other damage caused intentionally or by gross negligence;
- insofar as we have fraudulently concealed the defect or have assumed a guarantee for the quality of the item;
- in the case of items which have been used for a building in accordance with their customary use and have caused its defectiveness;
- in the case of statutory rights of recourse that you may assert against us in connection with rights arising from defects.
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(2) If you are not a consumer, but a businessman, a legal entity under public law or an institutional fund governed by public law, our place of business is the place of jurisdiction as well as the place of fulfilment for all services that follow from the business relationships that exist with us. The same condition applies to situations in which you are not associated with a general place of jurisdiction in Germany or the EU, as well as situations in which the place of residence or the usual place of residence is not known at the time of commencement of proceedings. This has no bearing on the capacity to call upon the court associated with another place of jurisdiction.
(3) The provisions of the UN Convention on Contracts for the International Sale of Goods are explicitly inapplicable.
II. Customer information
- Identity of the seller
Moluna GmbH
Engberdingdamm 27
48268 Greven
Germany
Telephone: 02571/5698933
E-Mail: abe@moluna.de
- Information regarding the conclusion of the contract
The technical steps associated with the conclusion of the contract, the contract conclusion itself and the correction options are executed in accordance to the regulations "conclusion of the contract" in our standard business terms (part I.).
- Contractual language, saving the text of the contract
3.1 Contract language shall be English.
3.2 The complete text of the contract is not saved with us. Before the order is sent, the contract data can be printed out or electronically saved using the browser’s print function. After the order is received by us, the order data, the legally-mandated details related to distance selling contracts and the standard business terms are re-sent to you via e-mail.
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Unless a different period is specified in the item description or our delivery conditions, the goods are delivered within 3-5 days after the conclusion of the contract (in case an advance payment has been agreed upon, after the payment authorisation).
6.2 If you are a consumer, the following is statutorily regulated: The risk of the sold item accidentally being destroyed or degraded during shipping only passes over to you when the item in question is delivered, regardless of whether or not the shipping operation is insured. This condition does not apply if you have independently commissioned a transport company that has not been specified by us or a person who has otherwise been appointed to execute the shipping operation.
If you are a businessman, the delivery and shipping operations take place at your own risk.
- Statutory warranty right
Liability for defects is governed by the “Warranty” provisions in our General Terms and Conditions of Business (Part I).
last update: 01.01.2022
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“Personal data” is any information relating to an identified or identifiable natural person.
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Contact us at any time. The contact details of the person responsible for data processing can be found in our legal notice.
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last update: 10.01.2022