Global Approach in Safety Testing
Language: English
Published by Springer New York Mrz 2015, 2015
Series: Book 4 of 38 - AAPS Advances in the Pharmaceutical Sciences
- Softcover
- New
Seller: BuchWeltWeit Ludwig Meier e.K., Bergisch Gladbach, GermanyBuchWeltWeit Ludwig Meier e.K.
AbeBooks seller since January 11, 2012
Condition: New
£ 140.27
Quantity: 2 available
Add to basketItem description from seller
This item is printed on demand - it takes 3-4 days longer - Neuware -This volume will consider one of ICH's major categories, Safety i.e. topics relating to in vitro and in vivo pre-clinical studies (Carcinogenicity Testing, Genotoxicity Testing, etc.). Since the start of the ICH process, many guidelines have been written, but even after ICH6 no explanations have been given during a formal Congress about the background of the ICH Guidance documents. Even more important than what has been written, might have been those thoughts of the experts that are not included in the Guidance documents. Why has the guideline been written as it is written, and why have some aspects been deleted. These and other related questions are the contents of this book, written by experts who were involved in the ICH process. Furthermore, the chapters will contain discussions on the 'lessons learnt' and 'future developments'. 328 pp. Englisch.
Seller Inventory # 9781489994073
- Title
- Global Approach in Safety Testing
- Author
- Joseph J Degeorge
- Publisher
- Springer New York Mrz 2015
- Publication year
- 2015
- Condition
- Neu
- Binding
- Taschenbuch
- Language
- English
- ISBN 10
- 1489994076
- ISBN 13
- 9781489994073
- Item weight
- 499 grams
- Dimensions
- 235x155x18 mm
- Series
- Book 4 of 38: AAPS Advances in the Pharmaceutical Sciences
"Synopsis" may belong to another edition of this title.
About the Author
Dr. Jan Willem van der Laan was from 1990-2007 heading the Section Pharmacology and Toxicology Assessment at the National Institute for Public Health and the Environment (RIVM, Bilthoven). In this function he was responsible for the advice on non-clinical safety aspects for the Netherlands ‘College’, the Medicines Evaluation Board. Since September 2007 he is still senior assessor in pharmacology and toxicology. He was from 2002-2010 project leader of the Teratology Information Service at the Institute. He moved in 2012 to the Medicines Evaluation Board located in Utrecht, but his role as senior assessor has not been changed. On behalf of this Board he is a member and vice-chair of the Safety Working Party (SWP) of the CHMP. His contributions to the International Conference on Harmonization started in early 1992 when he became a member of the Expert Working Group on Carcinogenicity Testing. Later on he became EU rapporteur for another topic in the Safety area, i.e. Immunotoxicology. In 2011 he finished as the EU rapporteur the Addendum for the Preclinical testing of Biotechnology-derived Proteins (ICH S6). In 2012 he is again involved in the new start of a topic on Carcinogenicity.
Joseph J. DeGeorge has a Ph.D. in Pharmacology from SUNY, Upstate Medical Center, Syracuse, NY, was a Postdoctoral Fellow at UNC, Chapel Hill, NC, and Burroughs-Wellcome Research Institute, and was a Senior Staff Fellow at the NIH/NIA in the Laboratory of Neuroscience. He has been actively engaged in the Safety and Multidisciplinary topics of the ICH as an Expert, Topic Rapporteur, and Safety Lead on numerous topics since the early 1990s. He is still actively engaged in ICH as of 2012. He has served these roles originally as a Food and Drug Administration representative and, following a brief hiatus, returned to the ICH as a PhRMA representative. He began his participation in the ICH process while serving as a Pharmacology and Toxicology reviewer inthe Neuropharmacology Division, CDER, FDA and took on increasing responsibility as his career progressed, culminating in the role of FDA ICH Safety Lead and Associate Director for Pharmacology and Toxicology for the Office of New Drugs, CDER/FDA. He joined the pharmaceutical industry in 2002, and has been Vice President of Global Safety Assessment at Merck &Co. since 2004. He also serves as the PhRMA Lead for ICH Safety topics, participating in the development of numerous new and revised ICH Safety Guidance's with a goal of enabling the safe and efficient development of new medicinal products.
"About the title" may belong to another edition of this title.
BuchWeltWeit Ludwig Meier e.K.
Bergisch Gladbach, Germany
AbeBooks seller since January 11, 2012
Shipping rates from Germany to U.S.A.
| Item | 5 to 15 business days | 5 to 15 business days |
|---|---|---|
| First item | £ 19.52 | £ 19.52 |
Payment methods
- Bank Wire Transfer
- Check
- Paypal
Seller's business information
BuchWeltWeit Ludwig Meier e.K.
Germany
Terms of sale
BuchWeltWeit Inh. Ludwig Meier e.K.
Inhaber: Ludwig Meier
De-Gasperi-Str. 8
51469 Bergisch Gladbach
Deutschland
Tel.: +49(0)22028659300
Fax: +49(0)22028659301
E-Mail: info@buchweltweit.de
Registergericht: Amtsgericht Köln
Registernummer: HRA 28253
Umsatzsteuer-Identifikationsnummer: DE815259907
Wir sind zur Teilnahme an einem Streitbeilegungsverfahren vor einer Verbraucherschlichtungsstelle weder verpflichtet noch bereit.
Right of withdrawal
If you are a consumer you can withdraw from the contract in accordance with the following. Consumer means any natural person who is acting for purposes which are outside his trade, business, craft or profession.
Information regarding the right of withdrawal
Statutory right to withdraw
You have the right to withdraw from this contract within 14 days without giving any reason.
The withdrawal period will expire after 14 days from the day on which you acquire, or a third party other than the carrier and indicated by you acquires, physical possession of the last good or the last lot or piece.
To exercise the right of withdrawal, electronically fill in and submit a clear statement on our website, under "My Purchases" in "My Account". We will communicate to you an acknowledgement of receipt of such a withdrawal on a durable medium (e.g. by e-mail) without delay.
To meet the withdrawal deadline, it is sufficient for you to send your communication concerning your exercise of the right of withdrawal before the withdrawal period has expired.
Effects of withdrawal
If you withdraw from this contract, we will reimburse to you all payments received from you, including the costs of delivery (except for the supplementary costs arising if you chose a type of delivery other than the least expensive type of standard delivery offered by us).
We may make a deduction from the reimbursement for loss in value of any goods supplied, if the loss is the result of unnecessary handling by you.
We will make the reimbursement without undue delay, and not later than 14 days after the day on which we are informed about your decision to withdraw from this contract.
We will make the reimbursement using the same means of payment as you used for the initial transaction, unless you have expressly agreed otherwise; in any event, you will not incur any fees as a result of such reimbursement.
We may withhold reimbursement until we have received the goods back, or you have supplied evidence of having sent back the goods, whichever is the earliest.
You shall send back the goods or hand them over to BuchWeltWeit Ludwig Meier e.K., Bergisch Gladbach, Germany, without undue delay and in any event not later than 14 days from the day on which you communicate your withdrawal from this contract to us. The deadline is met if you send back the goods before the period of 14 days has expired. You will have to bear the direct cost of returning the goods. You are only liable for any diminished value of the goods resulting from the handling other than what is necessary to establish the nature, characteristics and functioning of the goods.
Exceptions to the right of withdrawal
The right of withdrawal does not apply to:
- The delivery of newspapers, journals or magazines with the exception of subscription contracts; and
- The supply of digital content which is not supplied on a tangible medium (e.g. on a CD or DVD) if you accepted when you placed your order that we could start to deliver it, and that you could not withdraw once delivery had started.
Shipping terms
Der Versand ins Ausland findet IMMER mit DHL statt. Auch nach Österreich verschicken wir nur mit DHL! Daher Standardversand == Luftpost!