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MANAGEMENT PROCESSES DURING DRUG DEVELOPMENT: A SPECIAL REPORT ON RESEARCH & DEVELOPMENT IN CRO'S AND PHARMACEUTICAL COMPANIES

Amol B. Garde*, Dipali Jagtap, Ashish S. Pagariya


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  <identifier identifierType="DOI">10.5281/zenodo.2530501</identifier>
  <creators>
    <creator>
      <creatorName>Amol B. Garde*, Dipali Jagtap, Ashish S. Pagariya</creatorName>
      <affiliation>Sinhgad Institute of Pharmaceutical Sciences, Lonavala, Maharashtra.</affiliation>
    </creator>
  </creators>
  <titles>
    <title>MANAGEMENT PROCESSES DURING DRUG DEVELOPMENT: A SPECIAL REPORT ON RESEARCH &amp; DEVELOPMENT IN CRO'S AND PHARMACEUTICAL COMPANIES</title>
  </titles>
  <publisher>Zenodo</publisher>
  <publicationYear>2018</publicationYear>
  <subjects>
    <subject>Drug-Development Programs, Investigative New Drug (IND) Application, Product R&amp;D, Quality Assurance/ Documentation.</subject>
  </subjects>
  <dates>
    <date dateType="Issued">2018-11-30</date>
  </dates>
  <resourceType resourceTypeGeneral="Text">Journal article</resourceType>
  <alternateIdentifiers>
    <alternateIdentifier alternateIdentifierType="url">https://zenodo.org/record/2530501</alternateIdentifier>
  </alternateIdentifiers>
  <relatedIdentifiers>
    <relatedIdentifier relatedIdentifierType="DOI" relationType="IsVersionOf">10.5281/zenodo.2530500</relatedIdentifier>
    <relatedIdentifier relatedIdentifierType="URL" relationType="IsPartOf">https://zenodo.org/communities/iajpr</relatedIdentifier>
  </relatedIdentifiers>
  <rightsList>
    <rights rightsURI="http://creativecommons.org/licenses/by/4.0/legalcode">Creative Commons Attribution 4.0 International</rights>
    <rights rightsURI="info:eu-repo/semantics/openAccess">Open Access</rights>
  </rightsList>
  <descriptions>
    <description descriptionType="Abstract">&lt;p&gt;The most successful new drug-development programs require competent, caring, people-oriented leaders at all levels. Overwhelming social science data show that this approach will optimize productivity, efficiency, and creativity, while fostering employee growth, enthusiasm, cooperation, and loyalty. Companies are organized differently; for example, the various engineering responsibilities may be in one or more departments. A brief description of typical functions follows: _ Synthetic chemistry synthesizes NCE candidates for pharmacological testing. _ Pharmacology examines the in vivo activity of the NCE in animals. Other involved departments/disciplines that are equally important as the above groups include Analytical Chemistry, Biochemistry, Biopharmaceutics/ Pharmacokinetics/Drug Metabolism, Chemical Pilot Plant, Experimental Engineering, Packaging Development, and Statistics. Additional significant contributors include Purchasing and Quality Assurance/ Documentation.&lt;/p&gt;</description>
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