RESUMEN
This review of the Food and Drug Administration's Bioresearch Monitoring Program focuses on the inspection of clinical investigators who study investigational drugs. The differences between routine, "for-cause," and bioequivalency/bioavailability inspections are examined, with emphasis on the responsibilities of the clinical investigator, reasons for conducting the inspections, and problems found. Important aspects of the inspection report, such as protocol adherence, records maintenance, informed consent, institutional review board approval, and drug accountability, are outlined. The disqualification and consent agreement processes for investigators with serious problems are explained. FDA policies on third-party notification and remote data entry are noted.
Asunto(s)
Evaluación de Medicamentos/normas , Experimentación Humana , United States Food and Drug Administration/organización & administración , Comité de Profesionales , Estados UnidosRESUMEN
The physiologic characteristics of the biliary tract cannot be adequately evaluated without analyzing both the resistive and compliant characteristics of the common bile duct. We studied the compliance of the common bile duct in six anesthetized dogs. Saline was infused continuously while pressure was monitored with the sphincter of Oddi intact and tied off. The mean opening pressure of the sphincter was 8.45 cm H2O. In the obstructed duct, compliance was found to decrease with increasing pressure. The mean compliance for all five dogs at low pressures (below opening pressure) was 11.0 X 10(-2) microliter/cm H2O/mm2, and at high pressures was 1.7 X 10(-2) microliters/cm H2O/mm2. Changes in flow rate did not affect the compliance of the duct. Although the compliance of the duct was found to be nonlinear overall, it was nearly linear in both the high- and low-pressure ranges.