RESUMEN
Potential treatments for coronavirus disease 2019 (COVID-19) are being investigated at unprecedented speed, and successful treatments will rapidly be used in tens or hundreds of thousands of patients. To ensure safe and effective use in all those patents it is essential also to develop, at unprecedented speed, a means to provide frequently updated, optimal dosing information for all patient subgroups. Success will require immediate collaboration between drug developers, academics, and regulators.
Asunto(s)
Antivirales , Infecciones por Coronavirus , Relación Dosis-Respuesta a Droga , Desarrollo de Medicamentos , Reposicionamiento de Medicamentos , Efectos Colaterales y Reacciones Adversas Relacionados con Medicamentos , Pandemias , Neumonía Viral , Antivirales/farmacocinética , Antivirales/uso terapéutico , Betacoronavirus/efectos de los fármacos , Disponibilidad Biológica , Biomarcadores Farmacológicos/análisis , COVID-19 , Infecciones por Coronavirus/tratamiento farmacológico , Infecciones por Coronavirus/epidemiología , Desarrollo de Medicamentos/métodos , Desarrollo de Medicamentos/normas , Cálculo de Dosificación de Drogas , Monitoreo de Drogas/normas , Reposicionamiento de Medicamentos/métodos , Reposicionamiento de Medicamentos/normas , Efectos Colaterales y Reacciones Adversas Relacionados con Medicamentos/sangre , Efectos Colaterales y Reacciones Adversas Relacionados con Medicamentos/prevención & control , Humanos , Cooperación Internacional , Neumonía Viral/tratamiento farmacológico , Neumonía Viral/epidemiología , SARS-CoV-2 , Resultado del TratamientoRESUMEN
This report summarizes the discussions and recommendations of the workshop titled "Specific Population Drug Dosing Recommendations: Shifting from Clinical Studies to Predict and Confirm," which preceded the 2015 American Association of Pharmaceutical Scientists annual meeting. Participants from the pharmaceutical industry, regulatory agencies (FDA and EMA), and academia discussed the current state, challenges, opportunities, and future direction of utilizing model-based approaches to inform dosing recommendations in specific populations.