<?xml version="1.0" encoding="UTF-8"?>
<mods xmlns:xsi="http://www.w3.org/2001/XMLSchema-instance" xmlns="http://www.loc.gov/mods/v3" version="3.1" xsi:schemaLocation="http://www.loc.gov/mods/v3 http://www.loc.gov/standards/mods/v3/mods-3-1.xsd">
  <titleInfo>
    <title>Formulation and analytical development for low-dose oral drug products</title>
  </titleInfo>
  <name type="personal">
    <namePart>Zheng, Jack.</namePart>
  </name>
  <name type="corporate">
    <namePart>ebrary, Inc</namePart>
  </name>
  <typeOfResource>text</typeOfResource>
  <genre authority="marc">bibliography</genre>
  <genre authority="local">Electronic books.</genre>
  <originInfo>
    <place>
      <placeTerm type="code" authority="marccountry">nju</placeTerm>
    </place>
    <place>
      <placeTerm type="text">Hoboken, N.J</placeTerm>
    </place>
    <publisher>John Wiley &amp; Sons</publisher>
    <dateIssued>c2009</dateIssued>
    <dateIssued encoding="marc">2009</dateIssued>
    <issuance>monographic</issuance>
  </originInfo>
  <language>
    <languageTerm authority="iso639-2b" type="code">eng</languageTerm>
  </language>
  <physicalDescription>
    <form authority="marcform">electronic</form>
    <form authority="gmd">electronic resource</form>
    <extent>xxiii, 461 p. : ill.</extent>
  </physicalDescription>
  <tableOfContents>An 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 --</tableOfContents>
  <tableOfContents>Analytical 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.</tableOfContents>
  <note type="statement of responsibility">edited by Jack Zheng.</note>
  <note>Includes bibliographical references and index.</note>
  <note>Electronic reproduction. Palo Alto, Calif. : ebrary, 2013. Available via World Wide Web. Access may be limited to ebrary affiliated libraries.</note>
  <subject authority="lcsh">
    <topic>Drugs</topic>
    <topic>Dose-response relationship</topic>
  </subject>
  <subject authority="lcsh">
    <topic>Drugs</topic>
    <topic>Dosage</topic>
  </subject>
  <subject authority="lcsh">
    <topic>Oral medication</topic>
  </subject>
  <subject authority="lcsh">
    <topic>Drug development</topic>
  </subject>
  <classification authority="lcc">RM301.8 .F67 2009eb</classification>
  <classification authority="ddc" edition="22">615/.1</classification>
  <identifier type="isbn" invalid="yes"/>
  <identifier type="isbn" invalid="yes"/>
  <identifier type="lccn" invalid="yes"/>
  <identifier type="uri">http://site.ebrary.com/lib/rucke/Doc?id=10296483</identifier>
  <location>
    <url>http://site.ebrary.com/lib/rucke/Doc?id=10296483</url>
  </location>
  <recordInfo>
    <recordContentSource authority="marcorg">CaPaEBR</recordContentSource>
    <recordCreationDate encoding="marc">080303</recordCreationDate>
    <recordIdentifier source="CaPaEBR">ebr10296483</recordIdentifier>
  </recordInfo>
</mods>
