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New drug approval process : the global challenge /

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Bibliographic Details
Other Authors: Guarino, Richard A., 1935-
Format: Book
Language:English
Published: New York : Dekker, [2000]
Edition:Third edition.
Series:Drugs and the pharmaceutical sciences ; v. 100.
Subjects:
United States. > Food and Drug Administration.
Drug Evaluation > standards > United States.
Clinical Trials as Topic > standards > United States.
Table of Contents:
  • Regulatory aspects of new drug development
  • Drug development team
  • Nonclinical drug development: pharmacology, drug metabolism, and toxicology
  • The investigational new drug application and the investigator's brochure
  • General considerations of the NDA
  • Specific requirements, content, and format of an NDA
  • The biologic license application (BLA)
  • Chemistry, manufacturing and control requirements of the NDA, and ANDA
  • Clinical research development
  • Clinical research protocols
  • Adverse reactions and interactions of drugs
  • Institutional review board/independent ethics committee and informed consent: protecting subjects throughout the clinical research process
  • Statistical and data management: collaboration in clinical research
  • The management of clinical studies
  • Good clinical practices
  • Obligations of the investigator, sponsor, and monitor
  • Preparing for FDA inspections: manufacturing sites-- Quality assurance
  • The orphan drug and the Rx to OTC switch
  • Orphan drugs
  • Clinical development, regulations, and trends for OTC drugs
  • Effective methodology in expediting NDA approval
  • Industry and FDA liaison
  • Data presentation for FDA submissions: text and tabular exposition
  • The computer world in new drug development
  • Working with CRO
  • The evolving SMO in the United States.