Asunto(s)
Educación de Postgrado en Medicina/tendencias , Farmacología Clínica/educación , Adulto , Actitud del Personal de Salud , Educación de Postgrado en Medicina/economía , Empleo , Médicos Graduados Extranjeros , Humanos , Masculino , Salarios y Beneficios , Encuestas y Cuestionarios , Estados UnidosAsunto(s)
Hipertensión/sangre , Trastornos Puerperales/sangre , Renina/sangre , Aldosterona/orina , Femenino , Humanos , Postura , Embarazo , Ácido Vanilmandélico/orinaRESUMEN
The Food and Drug Administration recently has published general guidelines for the clinical evaluation of drugs used in adults and in infants and children. Specific guidelines for a number of drug classes, including anti-infective drugs, are also available. Marketing approval of a new drug requires that its benefits be judged to exceed its risks, that it be accurately and truthfully labeled, and that it be manufactured properly. Foreign studies are commonly accepted in support of new drugs, but approval requires at least one domestic trial unless the disease does not occur in the United States (for examply, tropical diseases).
Asunto(s)
Evaluación de Medicamentos , United States Food and Drug Administration , Adulto , Antibacterianos , Antivirales , Niño , Ensayos Clínicos como Asunto , Industria Farmacéutica , Humanos , Lactante , Legislación de Medicamentos , Estados UnidosRESUMEN
Three normotensive volunteers were given oral doses of alpha-tocopherylquinone. Blood pressure and its plasma concentrations were measured before and within 6 hours after taking this drug. Two dogs were given alpha-tocopherylquinone orally and after 3 days intravenously. Plasma concentrations were measured after each administration. Our result showed that this drug did not affect the blood pressure of normotensive individuals, and only small concentrations of alpha-tocopherylquinone were detected in plasma. In dogs, oral doses gave higher plasma levels than intravenous administration.
Asunto(s)
Presión Sanguínea/efectos de los fármacos , Vitamina E/farmacología , Adulto , Animales , Perros , Humanos , Cinética , Masculino , Quinonas/sangre , Quinonas/farmacología , Factores de Tiempo , Vitamina E/sangreRESUMEN
At the end of Phase II, a decision must be made as to whether or not the drug should be developed as a therapeutic agent. Such a decision may be based on many criteria in addition to the scientific data derived from the Phase II study. At this point, expert judgment is needed. One should like to assume that if the decision is made to proceed with the increasingly expensive and laborious process of further development, the drug will, barring some completely unforeseen misadventure, ultimately find its way into clinical therapeutics. Phase II studies, therefore, are the most crucial stage in the course of drug development. Planning of these studies requires great care and investigators of the highest caliber should be used for their conduct. The escalating costs of new drug development are resulting in an undesirable imbalance of efforts in the direction of studies characterized more by easily defined end points than by therapeutic needs. Industry, academia, and the FDA must all be concerned with facilitationg studies in areas of most-needed therapeutic advances.