Early drug development
Subtitle: strategies and routes to first-in-human trials
By: edited by Mitchell N. Cayen.
Contributors: Cayen, Mitchell N.
Publisher: Wiley
Published: 2010
Place of publication: Hoboken, N.J
Language: eng
ISBN-13: 9780470170861
Subjects: Drug development; Drug Discovery -- methods; Clinical Trials, Phase I as Topic; Drug Approval -- organization & administration; Drugs, Investigational -- therapeutic use; Research Design
Notes: Includes bibliographical references.
Table of contents: title: Drug discovery and early drug development / Mitchell N. Cayen; title: ADME strategies in lead optimization / Amin A. Nomeir; title: Prediction of pharmacokinetics and drug safety in humans / Peter L. Bullock; title: Bioanalytical strategies / Christopher Kemper; title: Chemistry, manufacturing and controls : the drug substance and formulated drug product / Orn Almarsson and Christopher J. Galli; title: Preclinical safety pharmacology studies recommended for supporting first-in-human (FIH) clinical trials / Duane B. Lakings; title: 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; title: Toxicokinetics in support of drug development / Gary Eichenbaum, Vangala Subrahmanyam, and Alfred Tonelli; title: Good laboratory practices / Anthony B. Jones, Kathryn Hackett-Fields, and Shari L. Perlstein; title: Estimation of starting dose for phase I clinical programs / Lorrene A. Buckley ... [et al.]; title: Exploratory INDS/CTAS / Mitchell N. Cayen; title: Unique considerations for biopharmaceutics / Laura P. Andrews and James D. Green; title: Project management and international regulatory requirements for first-in-human trials / Carolyn D. Finkle and Judith Atkins; title: First-in-human regulatory submissions / Mary Sommer ... [et al.].