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  <titleInfo>
    <title>Biotechnology operations</title>
    <subTitle>principles and practices</subTitle>
  </titleInfo>
  <name type="personal">
    <namePart>Roy, Michael Joseph</namePart>
    <role>
      <roleTerm authority="marcrelator" type="text">creator</roleTerm>
    </role>
    <role>
      <roleTerm type="text">author.</roleTerm>
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  </name>
  <name type="personal">
    <namePart>Centanni, John M.</namePart>
    <role>
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    </role>
  </name>
  <typeOfResource>text</typeOfResource>
  <genre authority="marc">bibliography</genre>
  <originInfo>
    <place>
      <placeTerm type="code" authority="marccountry">flu</placeTerm>
    </place>
    <dateIssued encoding="marc">2017</dateIssued>
    <edition>Second edition</edition>
    <issuance>monographic</issuance>
  </originInfo>
  <language>
    <languageTerm authority="iso639-2b" type="code">eng</languageTerm>
  </language>
  <physicalDescription>
    <form authority="marcform">print</form>
    <extent>xx, 476 pages : illustrations ; 25 cm</extent>
  </physicalDescription>
  <tableOfContents>Introduction to biotechnology operations : planning for success -- Project management -- Regulatory affairs -- Regulatory compliance -- Quality systems -- Biomanufacture -- Quality control -- Nonclinical studies -- Clinical trials.</tableOfContents>
  <note type="statement of responsibility">John M. Centanni, Michael J. Roy.</note>
  <note>Michael J. Roy's name appears first in the previous edition.</note>
  <note>Includes bibliographical references and index.</note>
  <subject authority="mesh">
    <topic>Biotechnology</topic>
    <topic>organization &amp; administration</topic>
  </subject>
  <subject authority="mesh">
    <topic>Biomedical Technology</topic>
    <topic>organization &amp; administration</topic>
  </subject>
  <subject authority="mesh">
    <topic>Program Development</topic>
    <topic>methods</topic>
  </subject>
  <subject authority="mesh">
    <topic>Total Quality Management</topic>
    <topic>methods</topic>
  </subject>
  <subject authority="mesh">
    <topic>Planning Techniques</topic>
  </subject>
  <classification authority="lcc">TP248.2 .R69 2017</classification>
  <classification authority="ddc">660.6</classification>
  <classification authority="nlm">W 82</classification>
  <identifier type="isbn">9781498758796 (hardback : acidfree paper)</identifier>
  <identifier type="lccn">2016034538</identifier>
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    <recordIdentifier source="PUCPR">19201345</recordIdentifier>
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