title: Nonimaging detectors in drug development and approval.
abstract: Regulatory applications for imaging biomarkers will expand in proportion to the validation of specific parameters as they apply to individual questions in the management of disease. This validation is likely to be applicable only to a particular class of drug or a single mechanism of action. Awareness among the world's regulatory authorities of the potential for these emerging technologies is high, but so is the cost to the sponsor (including the logistics of including images in a dossier), and therefore the pharmaceutical industry must evaluate carefully the potential benefit of each technology for its drug development programs, just as the authorities must consider carefully the extent to which the method is valid for the use to which the applicant has put it. For well-characterized tracer systems, it may be possible to design inexpensive cameras that make rapid assessments.
authors.forename: H N
authors.initials: HN
authors.lastname: Wagner
mesh_terms: D000777:Anesthetics / Q000037:antagonists & inhibitors; D015415:Biomarkers; D017277:Drug Approval; D009292:Narcotic Antagonists / Q000494:pharmacology; D010600:Pharmacology / Q000639:trends*; D014481:United States; D014486:United States Food and Drug Administration
chemical_list: D000777:Anesthetics; D015415:Biomarkers; D009292:Narcotic Antagonists