MARC Record from Library of Congress

LEADER: 02285cam a22003134a 4500
001 2009045882
003 DLC
005 20150129081016.0
008 091104s2010 njua b 000 0 eng
010 $a 2009045882
020 $a9780470170861 (cloth)
035 $a(DNLM)101518879
040 $aDNLM/DLC$cDLC
042 $apcc
050 00 $aRM301.25$b.E27 2010
060 10 $aQV 744$bE12 2010
082 00 $a615/.19$222
245 00 $aEarly drug development :$bstrategies and routes to first-in-human trials /$cedited by Mitchell N. Cayen.
260 $aHoboken, N.J. :$bWiley,$cc2010.
300 $axxv, 630 p. :$bill. ;$c25 cm.
504 $aIncludes bibliographical references and index.
505 0 $aDrug 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 -- Preclinical safety pharmacology studies recommended for supporting first-in-human (FIH) 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 Tonelli -- Good laboratory practices / Anthony B. Jones, Kathryn Hackett-Fields, and Shari L. Perlstein -- Estimation of 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 Sommer ... [et al.].
650 0 $aDrug development.
650 12 $aDrug Discovery$xmethods.
650 22 $aClinical Trials, Phase I as Topic.
650 22 $aDrug Approval$xorganization & administration.
650 22 $aDrugs, Investigational$xtherapeutic use.
650 22 $aResearch Design.
700 1 $aCayen, Mitchell N.