عنوان

Early drug development :

0470170867

0470613173

047061319X

9780470170861

9780470613177

9780470613191

9780470170861

b800206

Early drug development :

[Book]

strategies and routes to first-in-human trials /

edited by Mitchell N. Cayen.

Hoboken, N.J. :

Wiley,

©2010.

1 online resource (xxv, 630 pages) :

illustrations

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 [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].

0

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.

Wiley InterScience

10.1002/9780470613191

Early drug development.

9780470170861

Drug development.

Clinical Trials, Phase I as Topic.

Drug Approval-- organization & administration.

Drug Discovery-- methods.

Drugs, Investigational-- therapeutic use.

Research Design.

Drug development.

MEDICAL-- Drug Guides.

MEDICAL-- Nursing-- Pharmacology.

MEDICAL-- Pharmacology.

MEDICAL-- Pharmacy.

MED-- 023000

MED-- 058170

MED-- 071000

MED-- 072000

Cayen, Mitchell N.

20201207123505.0

pn

[Book]

Y