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Early drug development : strategies and routes to first-in-human trials /
The focus of early drug development has been the submission of an Investigational New Drug application to regulatory agencies. Early Drug Development: Strategies and Routes to First-in-Human Trials guides drug development organizations in preparing and submitting an Investigational New Drug (IND) ap...
| Clasificación: | Libro Electrónico |
|---|---|
| Otros Autores: | |
| Formato: | Electrónico eBook |
| Idioma: | Inglés |
| Publicado: |
Hoboken, N.J. :
Wiley,
©2010.
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| Temas: | |
| Acceso en línea: | Texto completo |
MARC
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| 037 | |a 10.1002/9780470613191 |b Wiley InterScience |n http://www3.interscience.wiley.com | ||
| 050 | 4 | |a RM301.25 |b .E27 2010eb | |
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| 245 | 0 | 0 | |a Early drug development : |b strategies and routes to first-in-human trials / |c edited by Mitchell N. Cayen. |
| 260 | |a Hoboken, N.J. : |b Wiley, |c ©2010. | ||
| 300 | |a 1 online resource (xxv, 630 pages) : |b illustrations | ||
| 336 | |a text |b txt |2 rdacontent | ||
| 337 | |a computer |b c |2 rdamedia | ||
| 338 | |a online resource |b cr |2 rdacarrier | ||
| 504 | |a Includes bibliographical references and index. | ||
| 505 | 0 | |a Drug discovery and early drug development / Mitchell N. Cayen -- ADME strategies in lead optimization / Amin A. Nomeir -- Prediction of pharmacokinetics and drug safety in humans / Peter L. Bullock -- Bioanalytical strategies / Christopher Kemper -- Chemistry, manufacturing and controls : the drug substance and formulated drug product / Orn Almarsson and Christopher J. Galli -- Nonclinical safety pharmacology studies recommended for support of first-in-human clinical trials / Duane B. Lakings -- Toxicology program to support initiation of a clinical phase I program for a new medicine / Hugh E. Black, Stephen B. Montgomery, and Ronald W. Moch -- Toxicokinetics in support of drug development / Gary Eichenbaum, Vangala Subrahmanyam, and Alfred P. Tonelli -- Good laboratory practice / Anthony B. Jones, Kathryn Hackett-Fields, and Shari L. Perlstein -- Estimation of human starting dose for phase I clinical programs / Lorrene A. Buckley [and others] -- Exploratory INDS/CTAS / Mitchell N. Cayen -- Unique considerations for biopharmaceutics / Laura P. Andrews and James D. Green -- Project management and international regulatory requirements for first-in-human trials / Carolyn D. Finkle and Judith Atkins -- First-in-human regulatory submissions / Mary M. Sommer [and others]. | |
| 588 | 0 | |a Print version record. | |
| 520 | |a The focus of early drug development has been the submission of an Investigational New Drug application to regulatory agencies. Early Drug Development: Strategies and Routes to First-in-Human Trials guides drug development organizations in preparing and submitting an Investigational New Drug (IND) application. By explaining the nuts and bolts of preclinical development activities and their interplay in effectively identifying successful clinical candidates, the book helps pharmaceutical scientists determine what types of discovery and preclinical research studies are needed in order to support. | ||
| 546 | |a English. | ||
| 590 | |a ProQuest Ebook Central |b Ebook Central Academic Complete | ||
| 650 | 0 | |a Drug development. | |
| 650 | 2 | |a Drug Discovery |x methods | |
| 650 | 2 | |a Clinical Trials, Phase I as Topic | |
| 650 | 2 | |a Drug Approval |x organization & administration | |
| 650 | 2 | |a Drugs, Investigational |x therapeutic use | |
| 650 | 2 | |a Research Design | |
| 650 | 6 | |a Médicaments |x Développement. | |
| 650 | 7 | |a MEDICAL |x Drug Guides. |2 bisacsh | |
| 650 | 7 | |a MEDICAL |x Pharmacology. |2 bisacsh | |
| 650 | 7 | |a MEDICAL |x Pharmacy. |2 bisacsh | |
| 650 | 7 | |a MEDICAL |x Nursing |x Pharmacology. |2 bisacsh | |
| 650 | 7 | |a Drug development |2 fast | |
| 700 | 1 | |a Cayen, M. N. | |
| 758 | |i has work: |a Early drug development (Text) |1 https://id.oclc.org/worldcat/entity/E39PCYJCf9v3j9kBm6fKKwbwWC |4 https://id.oclc.org/worldcat/ontology/hasWork | ||
| 776 | 0 | 8 | |i Print version: |t Early drug development. |d Hoboken, N.J. : Wiley, ©2010 |z 9780470170861 |w (DLC) 2009045882 |w (OCoLC)465378649 |
| 856 | 4 | 0 | |u https://ebookcentral.uam.elogim.com/lib/uam-ebooks/detail.action?docID=573863 |z Texto completo |
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