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PubMed1975

Thin-layer and gas chromatographic screening programs for new drug substances.

Procedures are described for evaluation of the thin-layer and gas chromatographic properties of new raw material drug substances over a broad spectrum of conditions. Chromatographic profiles are established for each drug, and these are used as starting points for analytical procedures for the drug, its synthetic precursors, and its degradation products. Thin-layer chromatography is performed initially by use of three absorbents and a series of six solvents. Gas chromatography is performed initially by temperature programming on a series of six different columns, followed by isothermal experiments. Evaluation of resulting chromatograms from both techniques determines whether more experiments are necessary or whether an analytical method can be developed based directly on one of the results of the initial screening.

Adsorption↗
PubMed2002

Outcome of the first 3-years of a DNA-based neonatal screening program for glutaric acidemia type 1 in Manitoba and northwestern Ontario, Canada.

Glutaric acidemia type 1 (GA1) is overrepresented in the aboriginal population of Island Lake, Manitoba, and northwestern Ontario who speak the Ojibway-Cree (Oji-Cree) dialect. The carrier frequency in these communities has been predicted to be as high as 1 in 10 individuals. Prior to beginning newborn screening for GA1 in May 1998, 18 of 20 affected patients diagnosed at this center have been from these high-risk communities. Most have followed an acute encephalopathic course with permanent neurologic sequelae and high mortality. They excrete small amounts of glutaric acid and 3-hydroxyglutaric acid and have significant residual enzyme activity. A single homozygous mutation in glutaryl-CoA-dehydrogenase (GCDH IVS-1 + 5g right arrow t) has been identified in this population. DNA-based newborn screening targeted to our high-risk communities was begun in order to provide presymptomatic detection and treatment of affected patients. Of the first 1176 newborns screened, 4 affected infants were identified and treated with a low-protein diet, carnitine, and riboflavin. All 4 infants have required numerous hospitalizations for treatment of intercurrent illnesses. Eventually, 3 infants presented with acute dystonic encephalopathy and seizures along with permanent neurological sequelae. One of these infants died unexpectedly at home at 18 months of age. The fourth, now 9 months old, has had a gastrostomy tube placed to facilitate fluid replacement in addition to a standard treatment protocol and is doing well. The reasons for our initial disappointing outcomes in the first 3 of 4 affected babies are likely multiple. Based on our early experience and that of other centers screening newborns for GA1, current therapeutic strategies may be insufficient in preventing the occurrence of neurologic sequelae in some children. An incomplete understanding of the neurotoxic mechanisms underlying this devastating disorder hampers effective management.

Canada↗
PubMed1992

[A screening program for the diagnosis of early forms of prostatic carcinoma].

Carcinoma of the prostate is at present one of the most frequently occurring malignancies in the male population. The disease can be cured only at the early stage when it has not yet spread beyond the limits of the gland. Early, clinically asymptomatic forms of carcinoma of the prostate can be diagnosed only by screening examinations of men. The justification of screening has, however, not been conclusively established and the fear of damaging the patient on examination could not be dispelled. The project of an international co-operative study was accepted in Stockholm in 1990 with the aim to address this question. The Department of Urology of Derer's Hospital with Policlinic, along with several urological, oncological, and research departments, have decided to join the project in order to contribute to the improvement of diagnosis and treatment of carcinoma of the prostate. (Fig. 1, Ref. 12.).

Humans↗
PubMed2005

Body mass index and lung cancer: a case-control study of subjects participating in a mass-screening program.

STUDY OBJECTIVES: An inverse relationship between body mass index (BMI) and the risk of lung cancer, suggesting that leanness is a risk factor for lung cancer, has been reported in previous studies. In order to evaluate the risk of lung cancer associated with lower levels of BMI in preclinical patients, we conducted a case-control study based on the results of community mass screening. DESIGN: The relationship between BMI (at the time of diagnosis, and at 1 to 5 years prior to diagnosis) and lung cancer was investigated in a case-control study of 363 lung cancer cases and 1,089 control subjects conducted between April 1993 and March 2003. Control subjects were selected from mass-screening subjects with no abnormalities on chest radiography and routine laboratory tests. RESULTS: In men, an inverse association between BMI and lung cancer was observed after adjustment for age and smoking (BMI < 20.8; range of the referent group, > or = 22.9 to < 25.0; odds ratio, 1.9; p = 0.0025; 95% confidence interval, 1.3 to 2.9). In women, however, no association was found between BMI and lung cancer (BMI < 20.8, p = 0.3868; and BMI </= 25.0, p = 0.4603, respectively). In addition, a negative association between BMI at 4 to 5 years prior to diagnosis and lung cancer was not observed in either gender (men, p = 0.2937 to 0.5783; women, p = 0.2042 to 0.9326). CONCLUSIONS: Our present study indicated the possibility that the previously reported association between leanness and the risk of lung cancer in women was not correct, and this apparent association might be influenced by other factors such as smoking and smoking-related respiratory diseases. A larger-scale cohort study combined with mass-screening project will confirm our results.

Aged↗
PubMed2003

An integrated functional genomics screening program reveals a role for BMP-9 in glucose homeostasis.

A coordinated functional genomics program was implemented to identify secreted polypeptides with therapeutic applications in the treatment of diabetes. Secreted factors were predicted from a diverse expressed-sequence tags (EST) database, representing >1,000 cDNA libraries, using a combination of bioinformatic algorithms. Subsequently, approximately 8,000 human proteins were screened in high-throughput cell-based assays designed to monitor key physiological transitions known to be centrally involved in the physiology of type 2 diabetes. Bone morphogenetic protein-9 (BMP-9) gave a positive response in two independent assays: reducing phosphoenolpyruvate carboxykinase (PEPCK) expression in hepatocytes and activating Akt kinase in differentiated myotubes. Purified recombinant BMP-9 potently inhibited hepatic glucose production and activated expression of key enzymes of lipid metabolism. In freely fed diabetic mice, a single subcutaneous injection of BMP-9 reduced glycemia to near-normal levels, with maximal reduction observed 30 hours after treatment. BMP-9 represents the first hepatic factor shown to regulate blood glucose concentration. Using a combination of bioinformatic and high-throughput functional analyses, we have identified a factor that may be exploited for the treatment of diabetes.

Animals↗
PubMed1999

A screening program for trisomy 21 at 10-14 weeks using fetal nuchal translucency, maternal serum free beta-human chorionic gonadotropin and pregnancy-associated plasma protein-A.

OBJECTIVE: To examine the potential impact of combining maternal age with fetal nuchal translucency thickness and maternal serum free beta-human chorionic gonadotropin (beta-hCG) and pregnancy-associated plasma protein-A (PAPP-A) in screening for trisomy 21 at 10-14 weeks of gestation. METHODS: Maternal serum free beta-hCG and PAPP-A were measured by Kryptor, a random access immunoassay analyzer using time-resolved amplified cryptate emission, in 210 singleton pregnancies with trisomy 21 and 946 chromosomally normal controls, matched for maternal age, gestation and sample storage time. In all cases the fetal crown-rump length and nuchal translucency thickness had been measured by ultrasonography at 10-14 weeks of gestation and maternal blood had been obtained at the time of the scan. The distributions (in multiples of the median; MoM) of free beta-hCG and PAPP-A (corrected for maternal weight) and fetal nuchal translucency (NT) were determined in the trisomy 21 group and the controls. Likelihood ratios for the various marker combinations were calculated and these were used together with the age-related risk for trisomy 21 in the first trimester to calculate the expected detection rate of affected pregnancies, at a fixed false-positive rate, in a population with the maternal age distribution of pregnancies in England and Wales. RESULTS: In a population with the maternal age distribution of pregnancies in England and Wales, it was estimated that, using the combination of maternal age, fetal nuchal translucency thickness and maternal serum free beta-hCG and PAPP-A, the detection of trisomy 21 pregnancies would be 89% at a fixed false-positive rate of 5%. Alternatively, at a fixed detection rate of 70%, the false-positive rate would be 1%. The inclusion of biochemical parameters added an additional 16% to the detection rate obtained using NT and maternal age alone. CONCLUSIONS: Rapid diagnostic technology like Kryptor, which can provide automated reproducible biochemical measurements within 30 min of obtaining a blood sample, will allow the development of interdisciplinary one-stop clinics for early fetal assessment. Such clinics will be able to deliver improved screening sensitivity, rapidly and more efficiently, leading to reduced patient anxiety and stress.

Adolescent↗