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: Anticancer drug development guide
    sub title: preclinical screening, clinical trials, and approval
  name:
    name part: Teicher, Beverly A.
    name part: 1952-
  name:
    name part: Andrews, Paul A.
  name:
    name part: SpringerLink (Online service)
  type of resource: text
  genre: bibliography
  genre: Electronic books.
  origin info:
    place:
      place term: nju
    date issued: 2004
    edition: 2nd ed.
    issuance: monographic
  language:
    language term: eng
  physical description:
    form: remote
    extent: 1 online resource (xiv, 450 pages) : illustrations
  abstract: In this thoroughly updated and expanded second edition of Beverly Teicher's widely used classic survey, Anticancer Drug Development Guide: Preclinical Screening, Clinical Trials, and Approval, leading cancer researchers from pharmaceutical companies, government laboratories, and academia provide a step-by-step guide to anticancer drug development from initial design through FDA approval. The authors have included new material on the use of high-throughput screening in industry, on specialized in vitro/in vivo procedures employed by the National Cancer Institute (NCI) in preclinical drug evaluations, and on nonclinical testing to support both human clinical trials, as well as trials of biologic oncology products. There are also new chapters on health-related quality of life (HRQL) issues in cancer clinical trials, and FDA review and requirements for approval of oncologic products. The chapters on phase I, II, and III clinical trials and on novel phase II clinical trial designs for targeted therapies have been significantly updated, along with those on cancer drug development in Europe, on working with the NCI, as well as on the FDA's role in cancer drug development and in setting requirements for approval. Authoritative and up-to-date, Anticancer Drug Development Guide: Preclinical Screening, Clinical Trials, and Approval takes oncologists, pharmacologists, medicinal chemists, and other cancer researchers on an encyclopedic tour of the cancer drug development and approval process, moving from the design and execution of high-throughput screens, to preclinical testing, to safety and toxicity testing under FDA requirements, to early clinical trials, and on to final FDA approval.
  table of contents: High-volume screening / Michel Pagä -- High-throughput screening in industry / Michael D. Boisclair ... [et al.] -- The NCI human tumor cell line (60-cell) screen: concept, implementation, and applications / Michael R. Boyd -- Human tumor screening / Axel-R. Hanauske, Susan G. Hilsenbeck, and Daniel D. Von Hoff -- Murine L1210 and P388 leukemias / William R. Waud -- In vivo methods for screening and preclinical testing: use of rodent solid tumors for drug discovery / Thomas Corbett ... [et al.] -- Human tumor xenograft models in NCI drug development / Michael C. Alley ... [et al.] -- Specialized in vitro/in vivo procedures employed by the NCI in preclinical drug evaluations / Melinda G. Hollingshead ... [et al.].
  table of contents: Patient-like orthotopic metastatic models of human cancer / Robert M. Hoffman -- Preclinical models for combination therapy / Beverly A. Teicher -- Models for biomarkers and minimal residual tumor / Beverly A. Teicher -- Spontaneously occurring tumors in companion animals as models for drug development / David M. Vail and Douglas H. Thamm -- Nonclinical testing: from theory to practice / Denis Roy and Paul A. Andrews -- Nonclinical testing for oncology drug products / Paul A. Andrews and Denis Roy -- Nonclinical testing for oncology biologic products / Carolyn M. Laurenìot, Denis Roy, and Paul A. Andrews.
  table of contents: Working with the national cancer institute / Paul Thambi and Edward A. Sausville -- Phase I trial design and methodology for anticancer drugs / Patrick V. Acevedo, Deborah L. Toppmeyer, and Eric H. Rubin -- Phase II trials: conventional design and novel strategies in the era of targeted therapies / Keith T. Flaherty and Peter J. O'Dwyer.
  table of contents: Drug development in Europe: the academic perspective / Chris Twelves ... [et al.] -- The phase III clinical cancer trial / Ramzi N. Dagher and Richard Pazdur -- Assessing tumor-related symptoms and health-related quality of life in cancer clinical trials: a regulatory perspective / Judy H. Chiao, Grant Williams, and Donna Griebel -- The role of the oncology drug advisory committee in the FDA review process for oncologic products / Leslie A. Vaccari -- FDA role in cancer drug development and requirements for approval / Susan Flamm Honig.
  note: edited by Beverly A. Teicher, Paul A. Andrews.
  note: Electronic resource.
  note: Master and use copy. Digital master created according to Benchmark for Faithful Digital Reproductions of Monographs and Serials, Version 1. Digital Library Federation, December 2002. http://purl.oclc.org/DLF/benchrepro0212 MiAaHDL
  note: digitized 2010 HathiTrust Digital Library committed to preserve pda MiAaHDL
  note: Includes bibliographical references and index.
  subject:
    topic: Antineoplastic agents
    topic: Development
  subject:
    topic: Antineoplastic Agents
    topic: standards
  subject:
    topic: Clinical Trials as Topic
  subject:
    topic: Drug Approval
  subject:
    topic: Drug Design
  subject:
    topic: Drug Evaluation, Preclinical
  subject:
    topic: Anticancéreux
    topic: Développement
  subject:
    topic: MEDICAL
    topic: Oncology
  subject:
    topic: HEALTH & FITNESS
    topic: Diseases
    topic: Cancer
  subject:
    topic: Antineoplastic agents
    topic: Development
  classification: RC271.C5 A6722 2004eb
  classification: 616.99/4061
  classification: QV 269 A62953 2004
  related item:
    title info:
      title: Anticancer drug development guide
    origin info:
      publisher: Totowa, N.J. : Humana Press, c2004
      edition: 2nd ed.
    identifier: (DLC) 2003024925
    identifier: (OCoLC)53443077
  related item:
    title info:
      title: Cancer drug discovery and development
  identifier: 1592597394 (electronic bk.)
  identifier: 9781592597390 (electronic bk.)
  identifier: 1588292282 (alk. paper)
  identifier: 9781588292285 (alk. paper)
  identifier: http://proxy.library.tamu.edu/login
  record info:
    record content source: N$T
    record creation date: 040318
    record change date: 20260422152745.0
    record identifier: in00003502241
    language of cataloging:
      language term: eng