rdf-syntax-grammar
mods:
  schema location: http://www.loc.gov/mods/v3 http://www.loc.gov/standards/mods/v3/mods-3-2.xsd
  title info:
    title: Specification of drug substances and products
    sub title: development and validation of analytical methods
  name:
    name part: Riley, Christopher M.
    role:
      role term: editor.
  name:
    name part: Rosanske, Thomas W.
    role:
      role term: editor.
  name:
    name part: Reid, George L.
    role:
      role term: editor.
  name:
    name part: Knovel (Firm)
  type of resource: text
  genre: Electronic books.
  origin info:
    place:
      place term: ne
    date issued: 2020
    issuance: monographic
  language:
    language term: eng
  physical description:
    form: remote
    extent: 1 online resource
  abstract: Specification of Drug Substances and Products: Development and Validation of Analytical Methods, Second Edition, presents a comprehensive and critical analysis of the requirements and approaches to setting specifications for new pharmaceutical products, with an emphasis on phase-appropriate development, validation of analytical methods, and their application in practice. This thoroughly revised second edition covers topics not covered or not substantially covered in the first edition, including method development and validation in the clinical phase, method transfer, process analytical technology, analytical life cycle management, special challenges with generic drugs, genotoxic impurities, topical products, nasal sprays and inhalation products, and biotechnology products. The book's authors have been carefully selected as former members of the ICH Expert Working Groups charged with developing the ICH guidelines, and/or subject-matter experts in the industry, academia and in government laboratories.
  note: edited by Christopher M. Riley, Thomas W. Rosanske, George L. Reid.
  subject:
    topic: Drugs
    topic: Standards
  subject:
    topic: Drug development
  subject:
    topic: Pharmaceutical Preparations
    topic: standards
  subject:
    topic: Drug Development
  subject:
    topic: Médicaments
    topic: Normes
  subject:
    topic: Médicaments
    topic: Développement
  subject:
    topic: Drug development
  subject:
    topic: Drugs
    topic: Standards
  classification: RS189 .S65 2020
  classification: 615.1/9
  classification: QV55
  related item:
    identifier: (OCoLC)1082966081
  identifier: 0081028253
  identifier: 9780081028247
  identifier: 0081028245
  identifier: 9780081028254
  identifier: http://proxy.library.tamu.edu/login
  record info:
    record content source: YDX
    record creation date: 200804
    record change date: 20230110224517.0
    record identifier: in00004640133
    language of cataloging:
      language term: eng