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Record Nr. |
UNINA9910808405203321 |
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Titolo |
Nonclinical safety assessment : a guide to international pharmaceutical regulations / / edited by William J. Brock, Kenneth L. Hastings, Kathy M. McGown |
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Pubbl/distr/stampa |
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Chichester, West Sussex, : John Wiley & Sons, 2013 |
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ISBN |
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1-118-51700-8 |
1-299-24266-9 |
1-118-51701-6 |
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Edizione |
[1st ed.] |
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Descrizione fisica |
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1 online resource (487 p.) |
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Altri autori (Persone) |
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BrockWilliam J |
HastingsKenneth L |
McGownKathy M |
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Disciplina |
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Soggetti |
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Drug development - International cooperation |
Drugs - Toxicology - International cooperation |
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Lingua di pubblicazione |
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Formato |
Materiale a stampa |
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Livello bibliografico |
Monografia |
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Note generali |
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Description based upon print version of record. |
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Nota di bibliografia |
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Includes bibliographical references and index. |
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Nota di contenuto |
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Introduction to the development of drugs / Kathy McGown -- ICH / Ken Hastings -- USFDA / Bill Brock -- Latin America : MERCOSUR countries / Cristiana Leslie Corra -- Canada / Mark T. Goldberg -- EMEA / Adam Woolley -- Africa / Fariza Feraoun -- China / Lijie Fu -- Japan / Kazuichi Nakamura -- India / K.S. Rao -- Australia / Doug Francis -- Chronic repeat dose testing / Shana Azri-Meehan -- Carcinogenicity / James Popp -- Genotoxicity / Mark Powley -- Developmental and reproductive toxicology / Robert Parker -- Juvenile testing and pediatric claim / Melissa Tassinari -- Immunotoxicology / Leigh Ann Burns Naas -- Biologics / Chris Ellis -- Vaccines / Robert House -- Phototoxicity and photocarcinogenicity / Chris Sambuco -- Degradants, impurities excipients, and metabolites / Bob Osterberg. |
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Sommario/riassunto |
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Bringing a new drug to market is a costly time-consuming process. Increased regional and international regulation over the last twenty years, while necessary, has only served to amplify these costs. In response to this escalation, developmental strategies have shifted towards a more global approach. In order to create the most cost- |
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