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

Resource Information

The instance Early drug development : strategies and routes to first-in-human trials, edited by Mitchell N. Cayen, (electronic resource) represents a material embodiment of a distinct intellectual or artistic creation found in Massey University Library, University of New Zealand. This resource is a combination of several types including: Instance, Electronic.

Image

http://syndetics.com/hw7.pl?isbn=9780470613191/LC.gif

Label

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

Title remainder

strategies and routes to first-in-human trials

Medium

electronic resource

Statement of responsibility

edited by Mitchell N. Cayen

Instantiates

• Early drug development : strategies and routes to first-in-human trials

Publication

• Hoboken, N.J., Wiley, c2010

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

9780470613191

Isbn Type

(electronic bk.)

Level of compression

unknown

Note

Wiley

Other physical details

ill

Quality assurance targets

not applicable

Record ID

.b33190069

Reformatting quality

unknown

Sound

unknown sound

Specific material designation

remote

System control number

(OCoLC)664573236