Three open-label, single-dose studies investigated the impact of hepatic or renal impairment on abiraterone acetate pharmacokinetics and safety/tolerability in non-cancer patients. Patients (n = 8 each group) with mild/moderate hepatic impairment or end-stage renal disease (ESRD), and age-, BMI-matched healthy controls received a single oral 1,000 mg abiraterone acetate (tablet dose); while patients (n = 8 each) with severe hepatic impairment and matched healthy controls received 125- and 2,000-mg abiraterone acetate (suspension doses), respectively (systemic exposure of abiraterone acetate suspension is approximately half to that of tablet formulation). Blood was sampled at specified timepoints up to 72 or 96 hours postdose to measure plasma abiraterone concentrations. Abiraterone exposure was comparable between healthy controls and patients with mild hepatic impairment or ESRD, but increased by 4-fold in patients with moderate hepatic impairment. Despite a 16-fold reduction in dose, abiraterone exposure in patients with severe hepatic impairment was about 22% and 44% of the Cmax and AUC∞ of healthy controls, respectively. These results suggest that abiraterone pharmacokinetics were not changed markedly in patients with ESRD or mild hepatic impairment. However, the capacity to eliminate abiraterone was substantially compromised in patients with moderate or severe hepatic impairment. A single-dose administration of abiraterone acetate was well-tolerated.
The colonization of broiler chickens with Salmonella can pose serious health and economic risks for both consumers and the poultry industry. Because colonization with Salmonella can lead to subsequent contamination of chicken carcasses during processing, preemptive control measures should include the reduction of this pathogen in chickens before slaughter. In this study, we evaluated the effect of sodium bisulfate, a potential antimicrobial feed additive, on Salmonella colonization of experimentally infected broiler chickens. Two hundred and forty 1-d-old chickens were infected orally with Salmonella enterica serotype Enteritidis and divided into 4 groups (each comprised of 60 chickens). Three groups received different concentrations of sodium bisulfate integrated into their feed, while the feed of the fourth group (positive control) was not treated. At time points before the broilers' slaughter age, different organs/tissues (liver, spleen, cecum, and bone marrow) and feces were aseptically collected and tested for the occurrence and density of Salmonella Enteritidis. Our results show that at 3 d postinfection, high colonization with Salmonella Enteritidis was detected and affected all tested tissues and fecal samples. Although colonization decreased across time, Salmonella Enteritidis persisted in the cecum, feces, spleen, and bone marrow, but not in the liver, until slaughter age. Furthermore, the addition of sodium bisulfate to the feed did not significantly reduce Salmonella Enteritidis numbers in infected chickens or affect the shedding of the pathogen.
Five experiments were conducted to determine the influence of potassium iodide (KI) on serum calcium in the laying hen. Serum calcium was significantly increased when hens were fed a diet containing 5000 p.p.m. I as KI. This occurred even though feed consumption, egg production and size of ovary and oviduct were significantly decreased. In some hens fed KI, serum calcium was increased to as high as 70 mg. %, a 163% increase. Most of the increase was in the form of non-diffusible calcium. Hens fed a diet containing 0.05% calcium had significantly reduced serum calcium values. When these calcium-deficient hens were fed 5000 p.p.m. I as KI, a significant increase in serum calcium occurred within 3 days and within 7 days their average serum calcium value was significantly greater than that of hens fed a diet containing 3.00% calcium. A combination of KI plus estradiol was significantly more effective in increasing serum calcium than was either compound alone. Although these data gave no indication as to the mechanism of action of KI on serum calcium they do offer a new model in which to study calcium metabolism in the laying hen.
Experiments were conducted to determine the effect of cropectomy on the total amount and calcium content of ingesta in the digestive tract of the laying hen at night, as well as to determine if any abnormal physiological changes had occurred in the cropectomized hens. Treatments were cropectomized, sham operated and unoperated control hens. The gizzards from cropectomized hens contained about twice as much feed at 7:30 p.m. as that of the controls. The gizzard weight, without contents, was also significantly heavier in cropectomized hens than that of the controls. At 7:30 p.m. total contents of the digestive system of cropectomized and control hens were 15.94 gm. versus 24.07 gm., respectively. The control birds also had 2.71 times more total calcium in the digestive system at 7:30 p.m. than the cropectomized birds. The contents of the small intestine of cropectomized birds had 17% more calcium at 7:30 p.m. than did that of the controls. However, by 5:30 a.m. the contents of the small intestine of the control birds had 3.17 times more calcium than did that of the cropectomized birds. No differences were found between treatments or between time periods in relation to tibia breaking strength, calcium content of tibia or percent tibia ash. The degree of dietary calcium deficiency at night appears to be greater with cropectomized hens, even though the gizzard compensates, in part, for the loss in storage capacity of the crop. It is hypothesized from these data that the crop is an important and necessary organ in the laying hen for supplying nutrients throughout the night when the hen is not consuming feed.
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