Asunto(s)
Aprobación de Drogas/historia , Pediatría/historia , Niño , Ensayos Clínicos como Asunto , Ectromelia/inducido químicamente , Glicoles de Etileno/efectos adversos , Historia del Siglo XX , Humanos , Sulfanilamida/efectos adversos , Talidomida/efectos adversos , Estados Unidos , United States Food and Drug AdministrationAsunto(s)
Humanos , Inhibidores de la Ciclooxigenasa/efectos adversos , Aprobación de Drogas/historia , Industria Farmacéutica/legislación & jurisprudencia , Infarto del Miocardio/inducido químicamente , Riesgo , Ensayos Clínicos como Asunto , Accidente Cerebrovascular/inducido químicamente , Sistemas de Registro de Reacción Adversa a Medicamentos , PublicidadAsunto(s)
Humanos , Aprobación de Drogas/historia , Inhibidores de la Ciclooxigenasa , Industria Farmacéutica/legislación & jurisprudencia , Infarto del Miocardio , Sistemas de Registro de Reacción Adversa a Medicamentos , Publicidad , Ensayos Clínicos como Asunto , Riesgo , Accidente CerebrovascularAsunto(s)
Ensayos Clínicos como Asunto/historia , Anticonceptivos Femeninos/historia , Anticonceptivos Masculinos/historia , Experimentación Humana/historia , Ensayos Clínicos como Asunto/legislación & jurisprudencia , Ensayos Clínicos como Asunto/normas , Aprobación de Drogas/historia , Femenino , Historia del Siglo XX , Humanos , Masculino , Selección de Paciente , Puerto Rico , Factores Sexuales , Estados UnidosRESUMEN
The first efforts to produce recombinant human growth hormone (GH) for clinical use were begun by scientists at Genentech, Inc., almost a generation ago, late in 1979. The very small market for GH that was predicted at the time led to this manufacturing effort being done as a demonstration project. Among the early issues was whether the Escherichia coli host cell could be routinely produced in a stable manner and be inactivated after the GH production run (as required by Federal guidelines) without the GH being permanently denatured. A 10 L E. coli process was developed, and phase I testing began in early 1981. The approval of this recombinant GH product by the FDA in 1985 paved the way for many improvements and a sustained production effort in the next decade. The more than 1990 fermentation runs have produced tons of E. coli and more than 130 pounds of GH for both clinical research and the treatment of severely short children.