Coverart for item
The Resource Early drug development : strategies and routes to first-in-human trials, edited by Mitchell N. Cayen, (electronic resource)

Early drug development : strategies and routes to first-in-human trials, edited by Mitchell N. Cayen, (electronic resource)

Label
Early drug development : strategies and routes to first-in-human trials
Title
Early drug development
Title remainder
strategies and routes to first-in-human trials
Statement of responsibility
edited by Mitchell N. Cayen
Contributor
Subject
Language
eng
Dewey number
615/.19
Illustrations
illustrations
Index
index present
Literary form
non fiction
Nature of contents
  • dictionaries
  • bibliography
http://library.link/vocab/relatedWorkOrContributorName
Cayen, Mitchell N
http://library.link/vocab/subjectName
  • Drug development
  • Drug Discovery
  • Clinical Trials, Phase I as Topic
  • Drug Approval
  • Drugs, Investigational
  • Research Design
Label
Early drug development : strategies and routes to first-in-human trials, edited by Mitchell N. Cayen, (electronic resource)
Instantiates
Publication
Antecedent source
unknown
Bibliography note
Includes bibliographical references and index
Color
multicolored
Contents
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.]
Control code
ocn664573236
Dimensions
unknown
Extent
1 online resource (xxv, 630 p.)
File format
unknown
Form of item
online
Isbn
9780470613177
Isbn Type
(electronic bk.)
Level of compression
unknown
Note
Wiley
Other physical details
ill
Quality assurance targets
not applicable
Reformatting quality
unknown
Sound
unknown sound
Specific material designation
remote
System control number
(OCoLC)664573236
Label
Early drug development : strategies and routes to first-in-human trials, edited by Mitchell N. Cayen, (electronic resource)
Publication
Antecedent source
unknown
Bibliography note
Includes bibliographical references and index
Color
multicolored
Contents
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.]
Control code
ocn664573236
Dimensions
unknown
Extent
1 online resource (xxv, 630 p.)
File format
unknown
Form of item
online
Isbn
9780470613177
Isbn Type
(electronic bk.)
Level of compression
unknown
Note
Wiley
Other physical details
ill
Quality assurance targets
not applicable
Reformatting quality
unknown
Sound
unknown sound
Specific material designation
remote
System control number
(OCoLC)664573236

Library Locations

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