RESUMO
The technical challenges of developing combination products were addressed in Part I of this two part article. Part II reviews the preclinical tests and shelf-life testing that are required using drug eluting stents and drug eluting beads as examples. Regulatory considerations and ways to simplify development are also examined.
Assuntos
Sistemas de Liberação de Medicamentos/métodos , Stents Farmacológicos/normas , Animais , Protocolos Antineoplásicos , Doxorrubicina/administração & dosagem , Sistemas de Liberação de Medicamentos/economia , Sistemas de Liberação de Medicamentos/instrumentação , Stents Farmacológicos/economia , Embolização Terapêutica/instrumentação , Embolização Terapêutica/métodos , Desenho de Equipamento/economia , Desenho de Equipamento/normas , Análise de Falha de Equipamento/métodos , Segurança de Equipamentos/métodos , Regulamentação Governamental , Humanos , Microesferas , Neoplasias/terapia , Quinolonas , Estudos de Validação como Assunto , Procedimentos Cirúrgicos VascularesRESUMO
The relationship between cognitive function and survivorship was examined in a community-dwelling sample. Survival analysis was used to examine how level and change in intellectual functioning, verbal memory, perceptual speed, and psychomotor speed were related to mortality in a sample of 601 individuals who subsequently died (decedents; n = 342 men; n = 259 women; M = 73.81 years of age) and a control group of 609 survivors (n = 296 men; n = 313 women; M = 71.96). The sample of survivors was selected to be of similar age and to have a similar level of education as the decedents. Individuals in the lowest 25th percentile of performance (crystallized abilities, visualization abilities, verbal memory, and perceptual and psychomotor speed) had a significant risk for subsequent mortality compared to individuals in the highest 25th percentile. However, after adjusting for demographic variables and psychomotor speed, only perceptual speed remained a significant risk factor for mortality. Significant 7-year declines (lowest 25th percentile) in measurements of Verbal Meaning, Spatial Ability, Reasoning Ability, and Psychomotor Speed were risk factors for subsequent mortality relative to those who had the least amount of decline. The relationship between mortality and cognitive function tended to be a specific rather than a pervasive phenomenon, even after adjusting for sociodemographic factors and psychomotor speed. Decrease in cognitive performance tended to be a better predictor of subsequent mortality than was the level of cognitive performance.
Assuntos
Cognição , Mortalidade , Adulto , Idoso , Idoso de 80 Anos ou mais , Estudos de Casos e Controles , Escolaridade , Feminino , Avaliação Geriátrica , Humanos , Estudos Longitudinais , Masculino , Pessoa de Meia-Idade , Testes Neuropsicológicos , Desempenho Psicomotor , Fatores de Risco , Fatores Socioeconômicos , Análise de Sobrevida , Saúde da População Urbana , Washington/epidemiologiaRESUMO
Older adults' ability to solve practical problems in 3 domains of daily living was assessed using a new measure of everyday problem solving, the Observed Tasks of Daily Living (OTDL). Findings showed that the OTDL formed internally consistent scales representing 3 distinct factors of everyday problem solving. Moreover, the OTDL showed convergent validity with related scales of a paper-and-pencil test. Older adults' performance on the OTDL was significantly correlated with their scores on measures of basic mental abilities. Path analysis showed that age affected older adults' performance on the OTDL directly and indirectly via cognitive abilities. Participants' education and health affected their everyday competence indirectly through cognitive abilities. The effects of perceptual speed and memory span were mediated by fluid and crystallized intelligence.