Use of pressure-hold test for sterilizing filter membrane integrity in radiopharmaceutical manufacturing

The bubble point test is the de facto standard for postproduction filter membrane integrity test in the radiopharmaceutical community. However, the bubble point test depends on a subjective visual assessment of bubbling rate that can be obscured by significant diffusive gas flows below the manufacturer's prescribed bubble point. To provide a more objective means to assess filter membrane integrity, this study evaluates the pressure-hold test as an alternative to the bubble point test. In our application of the pressure-hold test, the nonsterile side of the sterilizing filter is pressurized to 85% of the predetermined bubble point with nitrogen, the filter system is closed off from the pressurizing gas and the pressure is monitored over a prescribed time interval. The drop in pressure, which has a known relationship with diffusive gas flow, is used as a quantitative measure of membrane integrity. Characterization of the gas flow vs. pressure relationship of each filter/solution combination provides an objective and quantitative means for defining a critical value of pressure drop over which the membrane is indicated to be nonintegral. The method is applied to sterilizing filter integrity testing associated with the commonly produced radiopharmaceuticals, [¹⁸F]FDG and [¹¹C]PIB. The method is shown to be robust, practical and amenable to automation in radiopharmaceutical manufacturing environments (e.g., hot cells).     

Nonabsorbable marker and single, random stool samples used for measuring intestinal absorption of macronutrients in infants and children

To measure intestinal absorption by using a single, random stool sample, polyethylene glycol (PEG), 1 g/d, and a constant diet were given to healthy infants, with a constant PEG-to-macronutrient ratio. After 10 d equilibration, apparent intestinal absorption of macronutrients was estimated from a standard 3-d metabolic balance and compared with that estimated by using the ratio of PEG to macronutrients in a single random sample of feces. Correlation coefficients for this comparison were 0.649, 0.715, and 0.924 for nitrogen, carbohydrate, and fat, respectively. Additionally, apparent intestinal absorptions estimated from two separate consecutive 3-d metabolic-balance studies were compared, showing correlation coefficients of 0.106, 0.653, and 0.463 for nitrogen, carbohydrate, and fat, respectively. The random sample-marker technique appears to be acceptable for measuring apparent absorption of macronutrients and is at least as accurate as a standard 3-d metabolic-balance study.     

Relative effects of diarrhea, fever, and dietary energy intake on weight gain in rural Bangladeshi children

Quantitative studies of morbidity, food intake, and somatic growth were done prospectively during 14 mo for 70 children aged 5-18 mo in two Bangladeshi villages. When random-effect regression models were used, monthly changes in weight were inversely related to proportions of days in the month with fever and diarrhea and positively related to energy intake per kilogram body weight. Interestingly, weight changes did not vary with age in this interval. Estimates indicate that increasing energy intakes to the recommended World Health Organization level would have a significantly greater effect on weight gain than would the elimination of diarrhea and fever. With energy at recommended intake and diarrhea and fever prevalence as found in US children, weight gain is predicted to be near that of the international reference population. Therefore, interventions aimed at improving dietary intake may be as important as infection-control programs for improving growth of children in poor developing nations.     

Thiazide diuretics and the risk of hip fracture. Results from the Framingham Study

Thiazide diuretics may preserve bone mass and prevent elderly women's osteopenic fractures, but studies have not distinguished between thiazide preparations or examined former users. We performed a case-control study looking at thiazide use and subsequent hip fracture in postmenopausal female members of the Framingham Study cohort. Cases who had experienced a first hip fracture (n = 176) were compared with age-matched controls (n = 672). Results showed a modest protective effect of any recent thiazide use (not significant). However, recent pure thiazide users experienced significant protection against fracture (adjusted odds ratio, 0.31; 95% confidence interval, 0.11 to 0.88), whereas recent users of combination drugs containing thiazides experienced no protection (adjusted odds ratio, 1.16; 95% confidence interval, 0.44 to 3.05). Combination drugs generally contained only 25 mg of hydrochlorothiazide, suggesting that the small amount of thiazide was insufficient to preserve bone mass. Former thiazide users were not protected against fracture. In sum, recent pure thiazide use in women protects against hip fracture.     

THE RELEVANCE OF EVOLUTIONARY PSYCHOLOGY FOR PSYCHOTHERAPY

ABSTRACT The claims made for the contribution of Evolutionary Psychology to psychotherapy are questioned. The relevance of human evolutionary history is not disputed, but it is argued that insufficient account is taken of the unique features of human beings, that the polemical attacks made on the social and human sciences are irrational, that the hypothetical reconstructions of human evolution are frequently arbitrary and biased, and that the extent to which evolved innate'mentalities'are said to determine social roles ignores the evidence for the plasticity of human brains and for social influences in individual development. In its consistent bias in favour of innate rather than learned and culturally formed processes and in its language and assumptions EP underestimates the inherited and acquired capacities of human societies and individuals to change. It fails to take adequate account of the key evolutionary development whereby humans became symbol-making and symbol-using social animals whose individual psychological development involves processes, the understanding of which requires a new theoretical perspective. These features, combined with the absence of a clear model of practice, seriously limit the contribution of EP to psychotherapy.     

Breast pump adverse events: reports to the food and drug administration.

Breast pumps are medical devices used to express milk and maintain the milk supply. The purpose of this study was to characterize adverse events reported to the United States Food and Drug Administration (FDA) on breast pumps. Thirty-seven adverse event reports on breast pumps were identified from the Manufacturer and User Facility Device Experience database between 1992 and 2003. Four additional reports were found in the Device Experience Network database from 1992 to 1996. The most commonly reported adverse events for electric breast pumps were pain, soreness, or discomfort; the need for medical intervention; and breast tissue damage. Most frequently reported problems for manual breast pumps were breast tissue damage and infection. Contamination of breast milk during pumping was also reported. Breast pump adverse events are likely underreported to the FDA. Reporting adverse events is important for improving the design and manufacture of breast pumps and subsequently decreasing adverse events.     

'THOUGH THIS BE MADNESS YET THERE IS METHOD IN'T'1

ABSTRACT Freud's paper on the Schreber Case is considered from a contemporary perspective drawing on the object relations theorists. Some of Winnicott's ideas are used to illustrate how one might understand Schreber's predicament today. Although Freud's views on the role of repressed homosexual longings in the aetiology of Schreber's illness are not endorsed his prescience in the search for meaning in the patient's discourse is applauded.     

Therapeutic potpourri

Many older treatments should not be discarded because of newer modalities. Various dermatologic disorders may be controlled effectively by prescribing these older topical agents.     

A preliminary report of the short-term effect of carbonated beverage consumption on calcium metabolism in normal women

A variety of nutritional factors influence the bioavailability of calcium and increase a woman's risk of osteoporosis. Eight healthy women completed an 8-week metabolic study designed to investigate the effect of nonalcoholic carbonated beverage consumption on calcium metabolism. Compared with women receiving a control diet, women consuming a diet high in nonalcoholic carbonated beverages demonstrated similar mean serum levels of calcium, ionized calcium, phosphorus, alkaline phosphatase, parathyroid hormone, 1,25-dihydroxyvitamin D3, and osteocalcin. Twenty-four-hour urine volume, creatinine clearance, calcium-creatinine ratio, and phosphorus-creatinine ratio were similar during consumption of the diet high in nonalcoholic carbonated beverages and the control diet. Twenty-four-hour cyclic adenosine monophosphate-creatinine ratio was significantly lower in women consuming the diet high in nonalcoholic carbonated beverage compared with women receiving the control diet (342 +/- 27.4 nmol/mmol vs 409 +/- 22.1 nmol/mmol). Consumption of a diet high in nonalcoholic carbonated beverages on a short-term basis does not appear to affect adversely the serum or urinary markers of calcium metabolism.