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: Biosimilars
    sub title: design and analysis of follow-on biologics
  title info:
    title: Design and analysis of follow-on biologics
  name:
    name part: Chow, Shein-Chung
    name part: 1955-
    role:
      role term: creator
    role:
      role term: author.
  name:
    name part: ProQuest (Firm)
  type of resource: text
  genre: bibliography
  genre: Ebooks.
  genre: Electronic books.
  origin info:
    place:
      place term: flu
    date issued: 2014
    issuance: monographic
  language:
    language term: eng
  physical description:
    form: remote
    extent: 1 online resource : illustrations.
  abstract: "Biologic drug products are therapeutic moieties that are manufactured using a living system or organism. These are important life-saving drug products for patients with unmet medical needs. They also comprise a growing segment in the pharmaceutical industry. In 2007, for instance, worldwide sales of biological products reached $94 billion US dollars, accounting for about 15% of the pharmaceutical industry's gross revenue. Meanwhile, many biological products face losing their patents in the next decade."--
  table of contents: Introduction -- Bioequivalence experience for small-molecule drug products -- Regulatory requirements for assessing follow-on biologics -- Criteria for similarity -- Statistical methods for assessing average biosimilarity -- General approach for assessing biosimilarity -- Non-inferiority versus equivalence/similarity -- Statistical test for biosimilarity in variability -- Sample size for comparing variabilities -- Impact of variability on biosimilarity limits for assessing follow-on biologics -- Drug interchangeability -- Issues on immunogenicity studies -- CMC requirements for biological products -- Test for comparability in manufacturing process -- Stability analysis of biosimilar products -- Assessing biosimilarity using biomarker data -- Current issues in biosimilar studies.
  note: Shein-Chung Chow.
  note: Electronic resource.
  note: Description based on opening page (viewed Mar 21, 2018).
  note: Includes bibliographical references.
  subject:
    topic: Pharmaceutical biotechnology
  subject:
    topic: Pharmaceutical biotechnology industry
  subject:
    topic: Drugs
    topic: Generic substitution
  subject:
    topic: Pharmaceutical policy
  subject:
    topic: Biological products
  subject:
    topic: Biosimilar Pharmaceuticals
  subject:
    topic: Biostatistics
    topic: methods
  subject:
    topic: Drug Substitution
  subject:
    topic: Technology, Pharmaceutical
  classification: RS380 .C46 2014eb
  classification: QV 241
  classification: QV 241 C552b 2014eb
  related item:
    title info:
      title: Chapman & Hall/CRC biostatistics series
  identifier: 9781466579705
  identifier: 1466579706
  identifier: 9781466579699
  identifier: 1466579692
  identifier: http://proxy.library.tamu.edu/login
  record info:
    record content source: N$T
    record creation date: 130723
    record change date: 20190418084942.0
    record identifier: in00004534317
    language of cataloging:
      language term: eng