MARC Record from Library of Congress

LEADER: 03263cam a22003854a 4500
001 2008009573
003 DLC
005 20090326145847.0
008 080303s2009 njua b 001 0 eng
010 $a 2008009573
016 7 $a101467523$2DNLM
020 $a9780470056097 (cloth)
020 $a0470056096 (cloth)
035 $a(OCoLC)213008102
040 $aDNLM/DLC$cDLC$dNLM$dBAKER$dBTCTA$dYDXCP$dC#P$dIXA$dDLC
042 $apcc
050 00 $aRM301.8$b.F67 2009
082 00 $a615/.1$222
245 00 $aFormulation and analytical development for low-dose oral drug products /$cedited by Jack Zheng.
260 $aHoboken, N.J. :$bJohn Wiley & Sons,$cc2009.
300 $axxiii, 461 p. :$bill. ;$c25 cm.
504 $aIncludes bibliographical references and index.
505 0 $aAn overview / Jack Y. Zheng -- Challenges and strategies in formulation development of oral solid low-dose drug products / Jack Y. Zheng -- Particle size of drug substance and product content uniformity: theoretical considerations / Kevin C. Johnson -- Development of low-dose formulations using fluidized bed granulation / J. Joe Zhou, and Ralph Lipp -- Development of low-dose solid oral formulations using wet granulation / Ahmad Almaya -- Challenges in development and scale-up of low dose drug products by dry granulation: a case study / Mary T. Am Ende ... [et al.] -- Development of low-dose solid oral tablets using direct compression / Jack Y. Zheng and Robert L. Ternik -- Reduction of particle size of drug substance for low-dose drug products / Christopher L. Burcham ... [et al.] -- Function, quality, and regulations of pharmaceutical excipients for oral solid dosage forms / Jack Y. Zheng --
505 0 $aAnalytical method development: challenges and solutions for low-dose oral dosage forms / Beverly Nickerson ... [et al.] -- In vitro dissolution testing and method development / Vivian A. Gray, Jack Y. Zheng, and Norman N. Sesi -- Analysis of physical transformation of API during manufacture and storage / Gregory A. Stephenson -- Physical characterization tests for drug substances used in low-dose formulations / Ronald G. Lacocca -- An excipient library approach to analytical development for low-dose, solid oral dosage form drug products / Qing Chang ... [et al.] -- Cleaning verification for highly potent compounds / Brian W. Pack -- Containment challenges and strategies for potent compounds in the pharmaceutical industry / Victoria Cathcart, Sarah Jones, Beverly Nickerson -- Sample handling and containment in analytical testing laboratories / David Pattavina, Nancy Sage, Beverly Nickerson -- Regulatory considerations in the development of low-dose solid oral drug products / Ravi S. Harapanhalli.
650 0 $aDrugs$xDose-response relationship.
650 0 $aDrugs$xDosage.
650 0 $aOral medication.
650 0 $aDrug development.
650 12 $aChemistry, Pharmaceutical$xmethods.
650 22 $aAdministration, Oral.
650 22 $aDrug Evaluation, Preclinical$xmethods.
650 22 $aDrug Industry.
700 1 $aZheng, Jack.
856 42 $3Publisher description$uhttp://www.loc.gov/catdir/enhancements/fy0827/2008009573-d.html
856 41 $3Table of contents only$uhttp://www.loc.gov/catdir/enhancements/fy0827/2008009573-t.html