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41.
Feasibility,symptoms, adverse effects,and complications associated with noninvasive assessment of coronary flow velocity reserve in women with suspected or known coronary artery disease
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Daniel G. Morris Brett F. Truitt Angela Kong Norma Leyva 《Pharmaceutical development and technology》2013,18(5):451-460
The purpose of this study was to investigate the impact of processing, API loading, and formulation composition on the content uniformity of low-dose tablets made using direct compression (DC) and roller compaction (RC) methods at 1?kg scale. Blends of 1:1 microcrystalline cellulose/lactose or 1:1 microcrystalline cellulose/dicalcium phosphate anhydrous with active pharmaceutical ingredient (API) at loadings of 0.2, 1 and 5% were processed either by DC or RC. A statistical analysis showed that DC produced comparable content uniformity results to RC. Microcrystalline cellulose/lactose formulations had improved average potency compared to microcrystalline cellulose/dicalcium phosphate anhydrous formulations for both DC and RC. The impact of segregation in the DC blends and adhesion to equipment surfaces was assessed to aid in understanding potency trends. DC may be as suitable as RC for low-dose regime (e.g. <?1?mg) when manufacturing clinical supplies at small scale provided the API has a suitable particle size and potency loss to equipment is negligible. 相似文献
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Kristen E. Rhodin Vignesh Raman Oliver K. Jawitz Soraya L. Voigt Norma E. Farrow David H. Harpole Betty C. Tong Thomas A. D’Amico 《The Annals of thoracic surgery》2021,111(2):440-447
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Jonathan A. Bernstein R. Carter Bobbitt Linda Levin Roger Floyd Michael S. Crandall Robert A. Shalwitz 《The Journal of asthma》2013,50(4):255-262
Objective. Centrally installed ultraviolet (UV) irradiation units were investigated to determine the potential health benefits in mold-sensitized asthmatic children. Methods. Nineteen mold-sensitized asthmatic children 5 to 17 years of age with home central ventilation systems were enrolled in a 28-week double-blinded placebo controlled cross-over trial. Clinical outcome measurements included morning and evening peak expiratory flow rates (PEFR), PEFR variability, change in forced expiratory volume in 1 second (FEV1), change in total rhinoconjunctivitis and asthma symptom scores, change in rhinoconjunctivitis and asthma quality-of-life scores, and total (rescue and controller) medication use from baseline and between time periods. Environmental outcomes included changes in temperature, relative humidity, dew point, and indoor airborne mold and bacterial counts from baseline and between time periods. Analysis of variance (ANOVA) and regression analysis and t test were used to evaluate relationships between environmental exposure(s) and clinical outcome measurements during each study period. Results. Twelve male and seven female children, average age 10.6 years, were enrolled. A statistically significant improvement in PEFR variability in subjects receiving CREON2000 units followed by placebo units was observed (p < 0.05) across both treatment periods. Within group analysis during treatment period 1, a statistically significant improvement in reduction of asthma symptom scores, the number of days with asthma symptoms, total asthma medication use, and PEFR variability were observed in subjects receiving CREON2000 units versus placebo units (p < 0.05). No significant differences were observed between the CREON 2000 and placebo units for other clinical or environmental outcome measurements. Conclusions. Central UV irradiation was effective at reducing airway hyperresponsiveness manifested as PEFR variability and some clinical symptoms. A larger cohort controlled longitudinal study to validate the clinical health effects of UV irradiation as a primary indoor environmental intervention for allergic asthma is necessary to confirm this finding. 相似文献
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