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Dermatological Drug Development

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Title: Dermatological Drug Development
Description: This book uniquely summarizes approaches to developing dermatological drugs in a regulated environment from the perspective of the pharmaceutical industry. It brings together the insights of skilled and experienced industry experts to reveal the complexities of dermatological drug development, covering topical, oral, and biologic drugs. This book fills an important gap, as there is currently no other textbook addressing dermatological drug development, explaining and illustrating why unique nonclinical and clinical studies are necessary and how they are typically designed and conducted. The drug development process is also an evolving strategy that is characterized by communicating, negotiating, and agreeing with regulatory agencies, such as FDA (US), EMA (EU), and PMDA (Japan).
Authors: Tomoko Maeda-Chubachi, Author, Elizabeth Kernodle Hussey, Author, Sylvia Furst, Author
Resource Type: eBook.
Subjects: Drug development
Categories: BUSINESS & ECONOMICS / Industries / Pharmaceutical & Biotechnology, MEDICAL / Pharmacology
Database: eBook Collection (EBSCOhost)
FullText Links:
  – Type: ebook-pdf
Text:
  Availability: 0
Header DbId: nlebk
DbLabel: eBook Collection (EBSCOhost)
An: 2635303
RelevancyScore: 1097
AccessLevel: 6
PubType: eBook
PubTypeId: ebook
PreciseRelevancyScore: 1096.64697265625
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  Data: Dermatological Drug Development
– Name: Abstract
  Label: Description
  Group: Ab
  Data: This book uniquely summarizes approaches to developing dermatological drugs in a regulated environment from the perspective of the pharmaceutical industry. It brings together the insights of skilled and experienced industry experts to reveal the complexities of dermatological drug development, covering topical, oral, and biologic drugs. This book fills an important gap, as there is currently no other textbook addressing dermatological drug development, explaining and illustrating why unique nonclinical and clinical studies are necessary and how they are typically designed and conducted. The drug development process is also an evolving strategy that is characterized by communicating, negotiating, and agreeing with regulatory agencies, such as FDA (US), EMA (EU), and PMDA (Japan).
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  Data: <searchLink fieldCode="DE" term="%22Drug+development%22">Drug development</searchLink>
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RecordInfo BibRecord:
  BibEntity:
    Classifications:
      – Code: 615.19
        Scheme: ddc
        Type: prePub
    Languages:
      – Code: eng
        Text: English
    Subjects:
      – SubjectFull: Drug development
        Type: general
    Titles:
      – TitleFull: Dermatological Drug Development
        Type: main
  BibRelationships:
    HasContributorRelationships:
      – PersonEntity:
          Name:
            NameFull: Tomoko Maeda-Chubachi, Author
      – PersonEntity:
          Name:
            NameFull: Elizabeth Kernodle Hussey, Author
      – PersonEntity:
          Name:
            NameFull: Sylvia Furst, Author
      – PersonEntity:
          Name:
            NameFull: Tomoko Maeda-Chubachi, Author
      – PersonEntity:
          Name:
            NameFull: Elizabeth Kernodle Hussey, Author
      – PersonEntity:
          Name:
            NameFull: Sylvia Furst, Author
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      – BibEntity:
          Dates:
            – D: 01
              M: 01
              Type: published
              Y: 2020
            – D: 24
              M: 12
              Type: profile
              Y: 2020
          Identifiers:
            – Type: isbn-print
              Value: 9781527558182
            – Type: isbn-electronic
              Value: 9781527559677
          Titles:
            – TitleFull: Dermatological Drug Development
              Type: main
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