Early drug development: strategies and routes to first-in-human trials
Gespeichert in:
| Format: | Elektronisch E-Book |
|---|---|
| Sprache: | English |
| Veröffentlicht: |
Hoboken, N.J.
Wiley
c2010
|
| Schlagworte: | |
| Online-Zugang: | TUM01 Volltext |
| Beschreibung: | Includes bibliographical references and index 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 ... [et al.] -- 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 ... [et al.] |
| Beschreibung: | 1 Online-Ressource (xxv, 630 p.) |
| ISBN: | 0470613173 047061319X 9780470613177 9780470613191 |
Internformat
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Datensatz im Suchindex
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| isbn | 0470613173 047061319X 9780470613177 9780470613191 |
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| spelling | Early drug development strategies and routes to first-in-human trials edited by Mitchell N. Cayen Hoboken, N.J. Wiley c2010 1 Online-Ressource (xxv, 630 p.) txt rdacontent c rdamedia cr rdacarrier Includes bibliographical references and index 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 ... [et al.] -- 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 ... [et al.] MEDICAL / Drug Guides bisacsh MEDICAL / Pharmacology bisacsh MEDICAL / Pharmacy bisacsh MEDICAL / Nursing / Pharmacology bisacsh Medizin Drug development Drug Discovery / methods Clinical Trials, Phase I as Topic Drug Approval / organization & administration Drugs, Investigational / therapeutic use Research Design MEDICAL / Drug Guides / bisacsh MEDICAL / Pharmacology / bisacsh MEDICAL / Pharmacy / bisacsh MEDICAL / Nursing / Pharmacology / bisacsh Arzneimittelentwicklung (DE-588)4143176-5 gnd rswk-swf Klinische Prüfung (DE-588)4031192-2 gnd rswk-swf 1\p (DE-588)4143413-4 Aufsatzsammlung gnd-content Arzneimittelentwicklung (DE-588)4143176-5 s Klinische Prüfung (DE-588)4031192-2 s 2\p DE-604 Cayen, Mitchell N. Sonstige oth Erscheint auch als Druck-Ausgabe, Hardcover 978-0-470-17086-1 http://search.ebscohost.com/login.aspx?direct=true&scope=site&db=nlebk&db=nlabk&AN=335253 Verlag Volltext 1\p cgwrk 20201028 DE-101 https://d-nb.info/provenance/plan#cgwrk 2\p cgwrk 20201028 DE-101 https://d-nb.info/provenance/plan#cgwrk |
| spellingShingle | Early drug development strategies and routes to first-in-human trials MEDICAL / Drug Guides bisacsh MEDICAL / Pharmacology bisacsh MEDICAL / Pharmacy bisacsh MEDICAL / Nursing / Pharmacology bisacsh Medizin Drug development Drug Discovery / methods Clinical Trials, Phase I as Topic Drug Approval / organization & administration Drugs, Investigational / therapeutic use Research Design MEDICAL / Drug Guides / bisacsh MEDICAL / Pharmacology / bisacsh MEDICAL / Pharmacy / bisacsh MEDICAL / Nursing / Pharmacology / bisacsh Arzneimittelentwicklung (DE-588)4143176-5 gnd Klinische Prüfung (DE-588)4031192-2 gnd |
| subject_GND | (DE-588)4143176-5 (DE-588)4031192-2 (DE-588)4143413-4 |
| title | Early drug development strategies and routes to first-in-human trials |
| title_auth | Early drug development strategies and routes to first-in-human trials |
| title_exact_search | Early drug development strategies and routes to first-in-human trials |
| title_full | Early drug development strategies and routes to first-in-human trials edited by Mitchell N. Cayen |
| title_fullStr | Early drug development strategies and routes to first-in-human trials edited by Mitchell N. Cayen |
| title_full_unstemmed | Early drug development strategies and routes to first-in-human trials edited by Mitchell N. Cayen |
| title_short | Early drug development |
| title_sort | early drug development strategies and routes to first in human trials |
| title_sub | strategies and routes to first-in-human trials |
| topic | MEDICAL / Drug Guides bisacsh MEDICAL / Pharmacology bisacsh MEDICAL / Pharmacy bisacsh MEDICAL / Nursing / Pharmacology bisacsh Medizin Drug development Drug Discovery / methods Clinical Trials, Phase I as Topic Drug Approval / organization & administration Drugs, Investigational / therapeutic use Research Design MEDICAL / Drug Guides / bisacsh MEDICAL / Pharmacology / bisacsh MEDICAL / Pharmacy / bisacsh MEDICAL / Nursing / Pharmacology / bisacsh Arzneimittelentwicklung (DE-588)4143176-5 gnd Klinische Prüfung (DE-588)4031192-2 gnd |
| topic_facet | MEDICAL / Drug Guides MEDICAL / Pharmacology MEDICAL / Pharmacy MEDICAL / Nursing / Pharmacology Medizin Drug development Drug Discovery / methods Clinical Trials, Phase I as Topic Drug Approval / organization & administration Drugs, Investigational / therapeutic use Research Design MEDICAL / Drug Guides / bisacsh MEDICAL / Pharmacology / bisacsh MEDICAL / Pharmacy / bisacsh MEDICAL / Nursing / Pharmacology / bisacsh Arzneimittelentwicklung Klinische Prüfung Aufsatzsammlung |
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