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PubMed1975

Anomeric configuration of the dolichyl D-mannosyl phosphate formed in calf pancreas microsomes.

Dolichyl D-[14C]mannosyl phosphate formed in calf pancreas microsomes was compared to dolichyl alpha-D-[14C]mannopyranosyl phosphate, a chemical synthesis of which is described. Jack bean alpha-mannosidase, which converted citronellyl alpha-D-mannopyranosyl phosphate, but not its beta anomer, to citronellyl phosphate and D-mannose, was effective in releasing D-[14C]mannose from dolichyl alpha-D-[14C]manopyranosyl phosphate in the presence of detergent. In contrast, alpha-mannosidase did not cause any significant release from the pancreatic dolichyl D-[14C]mannosyl phosphate. Alkali treatment (0.1 M NaOH in propanol at 65 and 90 degrees) degraded both dolichyl D-[14C]mannosyl phosphates with the formation of water-soluble 14C-labeled products. The pattern of 14C-labeled breakdown products formed from the synthetic dolichyl alpha-D-[14C]mannopyranosyl phosphate differed from that obtained from the pancreatic dolichyl D-[14C]mannosyl phosphate. Dolichyl alpha-D-[14C]mannopyranosyl phosphate yielded several 14C-labeled products, including a trace of D-[14C]mannosyl phosphate, and an acidic fraction which appeared to result from degradation of D-[14C]mannose. The pancreatic dolichyl D-[14C]mannosyl phosphate gave various products, depending on the temperature of the reaction: at 90 degrees, 20 to 30% of the radioactivity was found in D-[14C]mannosyl phosphate and the rest in acidic breakdown products; at 65 degrees, about two-thirds of the radioactivity was recovered in a compound which behaved as D-MANNOSE 2-PHOSPHATE, A Product characteristic of a beta-linked D-mannosyl residue. It is concluded that the pancreatic compound is dolichyl beta-D-[14C]mannosyl phosphate.

Animals↗
PubMed1985

Nitrogen Metabolism in Senescent Flag Leaves of Wheat (Triticum aestivum L.) in the Light.

Nitrogen metabolism was examined in senescent flag leaves of 90- to 93-day-old wheat (Triticum aestivum L. cv Yecora 70) plants. CO(2) assimilation and the levels of protein, chlorophyll, and nitrogen in the leaves decreased with age. Glutamine synthetase activity decreased to one-eighth of the level in young flag leaves. Detached leaves were incubated (with the cut base) in (15)N-labeled NH(3), glutamate, or glycine in the light (1.8 millieinstein per square meter per second) at 25 degrees C in an open gas exchange system under normal atmospheric conditions for up to 135 minutes. The (15)N-enrichment of various amino acids derived from these (15)N-substrates were examined. The amido-N of glutamine was the first (15)N-labeled product in leaves incubated with (15)NH(4)Cl whereas serine, closely followed by the amido- and amino-N of glutamine, were the most highly (15)N-labeled products during incubation with [(15)N]glycine. In contrast, aspartate and alanine were the first (15)N-labeled products when [(15)N] glutamate was used. These results indicate that NH(3) was assimilated via glutamine synthetase and glutamate synthase activities and the photorespiratory nitrogen cycle remained functional in these senescent wheat flag leaves. In contrast, an involvement of glutamate dehydrogenase in the assimilation of ammonia could not be detected in these tissues.

Journal Article↗
PubMed1987

Labeling and functional language in a case of psychological mutism.

Talking was increased in an 11-year-old girl who recently had stopped talking to anyone in any setting, despite the absence of biological factors, mental retardation, and autism. Productive labeling (correctly naming picture cards) and functional language (talking about picture cards in the absence of such pictures) were interspersed with a series of treatment packages (including verbal instructions, imitation, tokens, and praise). Interventions for productive labeling were programmed in a changing-criterion design. Interventions for functional language were programmed in an ABC design. Higher levels of productive labeling and functional language were noted with the introduction of the particular package, in comparison to baseline. The results also showed the generalization of the procedures to the shaping of functional language in the absence of picture cards.

Behavior Therapy↗
PubMed1981

[Production of labelled gamma globulin for the detection of Chlamydia].

A method was worked out for the production of an antichlamydial fluorescent serum to be used in the direct immunofluorescence test. Used were the methods of culturing Chlamydia in chick embryos and cell cultures, light and electron microscopy, differential centrifugation and supercentrifugation, gel chromatography in Sepharose, ultracentrifugation in saccharose, hyperimmunization of guinea pigs, conjugation of gammaglobulin with fluorescein isothiocyanate, complement fixation, and the direct immunofluorescence itself. Applied was a new immunologic scheme for the production of fluorescent sera. The guinea pigs were hyperimmunized twice and three times at 30-day intervals with highly purified, highly concentrated and adjuvant-treated chlamydial suspensions. It was concluded that the main condition for the production of high titer labelled gammaglobulins was to obtain purified and concentrated chlamydial antigens and use these with an adjuvant. To indicate Chlamydia in testing the conjugates it is essential to prepare standard test lamellas infected at high multiplicity of purified and concentrated Chlamydia.

Animals↗
PubMed2006

Analysis of 18F-labelled synthesis products on TLC plates: comparison of radioactivity scanning, film autoradiography, and a phosphoimaging technique.

We compared radioactivity scanning, film autoradiography, and digital photostimulated luminescence (PSL) autoradiography (phosphoimaging technique) in detection of radioactivity on thin-layer chromatography (TLC) plates. TLC combined with radioactivity detection is rapid, simple, and relatively flexible. Here, (18)F-labelled synthesis products were analyzed by TLC and the radioactivity distribution on the plates determined using the three techniques. Radioactivity scanning is appropriate only with good chromatographic resolution and previously validated scanning parameters. Film autoradiography exhibits poor linearity if radioactivity varies greatly. PSL provides high sensitivity and resolution and superior linearity compared with the other methods.

Aminopyridines↗
PubMed2005

Assessment of geriatric information on the drug label for commonly prescribed drugs in older people.

Older people contribute to a significant portion of all prescription drug use and expenditures in the United States. Despite this, older people are often excluded from clinical trials examining the safety and efficacy of drugs. It is unclear to what extent drugs commonly used in older people contain information about prescribing in older people on their product labeling. The objective of this study was to determine the availability of pharmacokinetic, safety, and dosing information with reference to older people on product labels or package inserts (PIs) for commonly prescribed drugs in patients aged 65 and older. The top 50 oral drugs prescribed at the University of Pittsburgh Medical Center were identified through a computerized search of pharmacy records. PIs for these drugs were evaluated for information on elderly patients. Information on drug use in older people was found in 41 (82%) of the PIs. Drugs marketed after 1990 were more likely to contain information on geriatric use, with pharmacokinetic information being the most common type. Approximately 50% of the PIs contained precautionary statements for older people, but most did not provide any specific problems that might be encountered in this population. Only 28 (56%) PIs had dosing information available, and of these, just eight provided specific milligram recommendations for elderly patients. This analysis provides evidence that more should be done to improve the availability of prescribing information, particularly dosing and safety, on drug labels for older people. Additional regulatory action requiring this information to be included on drug product labels may be warranted.

Aged↗
PubMedDate not supplied

Generation and initial characterization of Pseudomonas stutzeri KC mutants with impaired ability to degrade carbon tetrachloride.

Under iron-limiting conditions, Pseudomonas stutzeri KC secretes a small but as yet unidentified factor that transforms carbon tetrachloride (CT) to CO2 and nonvolatile products when activated by reduction at cell membranes. Pseudomonas fluorescens and other cell types activate the factor. Triparental mating was used to generate kanamycin-resistant lux::Tn5 recombinants of strain KC. Recombinants were streaked onto the surface of agar medium plugs in microtiter plates and were then screened for carbon tetrachloride degradation by exposing the plates to gaseous 14C-carbon tetrachloride. CT+ recombinants generated nonvolatile 14C-labeled products, but four CT- recombinants did not generate significant nonvolatile 14C-labeled products and had lost the ability to degrade carbon tetrachloride. When colonies of P. fluorescens were grown next to colonies of CT+ recombinants and were exposed to gaseous 14C-carbon tetrachloride, 14C-labeled products accumulated around the P. fluorescens colonies, indicating that the factor secreted by CT+ colonies had diffused through the agar and become activated. When P. fluorescens was grown next to CT- colonies, little carbon tetrachloride transformation was observed, indicating a lack of active factor. Expression of lux reporter genes in three of the CT- mutants was regulated by added iron and was induced under the same iron-limiting conditions that induce carbon tetrachloride transformation in the wild-type.

Biotransformation↗
PubMed2005

Evaluation of five probiotic products for label claims by DNA extraction and polymerase chain reaction analysis.

Label claims were evaluated for five probiotic products. Specific oligonucleotide primers were designed for 11 species from the Bifidobacterium, Lactobacillus, and Streptococcus genera. Polymerase chain reaction, gel electrophoresis, and amplicon excision with DNA sequencing were performed: Sequence analysis and DNA homology comparisons followed. Bifidobacterium bifidum was not detected in two of the five samples by PCR analysis. Also, Lactobacillus species were found in two of the five product samples for which the species was not listed as an ingredient. We conclude that (1) lack of B. bifidum in two probiotic products may be attributed to different preparation standards among probiotic manufacturers, and (2) identificaition of additional Lactobacillus species may represent contamination of the samples related to the fact that manufacturers utilize shared equipment to produce all probiotics and PCR is a highly sensitive technique.

Bifidobacterium↗
PubMed1982

Biosynthesis in vitro of a blood group B-active fucose-containing hexaglycosylceramide from neolactopentaosylceramide in bovine spleen.

A solubilized alpha-fucosyltransferase activity has been isolated from a bovine spleen Golgi-rich membrane fraction. The enzyme transfers fucose from GDP-beta-L-fucose to a blood group B-active pentaglycosylceramide acceptor (Gal(alpha 1-3)Gal(beta 1-4)GlcNAc(beta 1-3)Gal(beta 1-4)Glc-ceramide) isolated from rabbit erythrocytes. Treatment of the membranes with 0.2% (final concentration) sodium taurodeoxycholate detergent produced maximal recovery (90%) of activity. A cationic detergent, G-3634-A, is required for optimal activity and the enzyme does not require addition of exogenous metal ion for activation. The purified 14C-labeled product of the reaction migrated with human blood group B-active hexaglycosylceramide on Silica Gel G thin layer plates. After treatment with fig alpha-galactosidase, the radioactive pentaglycosylceramide migrated with human H-active glycosphingolipid. The 14C-labeled product inhibited the hemagglutination reaction of B-type erythrocytes with Bandeiraea simplicifolia lectin and anti-B serum and formed a precipitin line with Euonymus europeus lectin. Treatment of the 14C-labeled product with alpha-fucosidase (Venus mercenaria) or weak acid at 100 degrees C for 2 h released 80-90% of the bound radioactive fucose.

ABO Blood-Group System↗
PubMed1980

Hydralazine-pyrimidine interactions may explain hydralazine-induced lupus erythematosus.

Hydralazine, the prototypic drug that induces systemic lupus erythematosus, reacts with thymidine and deoxycytidine. Analysis of a reaction mixture of therapeutic concentrations of hydralazine with labeled thymidine reveals at least four labeled products. At higher concentrations, hydralazine reacts with labeled deoxycytidine to form at least three labeled products. Formation of these products is markedly enhanced by exposure to ultraviolet light. The reaction of hydralazine with thymidine and deoxycytidine may be in part responsible for initiating drug-induced systemic lupus erythematosus.

DNA↗
PubMed2005

Use of 13C labeling and NMR spectroscopy for the investigation of degradation pathways of Amadori compounds.

The degradation pathways of Amadori compounds in vivo have not been fully understood because of the lack of suitable techniques although the compounds are considered to be key intermediates in glycation, which contributes to the development of pathologies associated with various chronic and age-related diseases. A new approach using 13C labeling and NMR spectroscopy has thus been described to obtain more insight into the degradation pathways. A 13C-labeled model Amadori compound, [1-13C]Nepsilon-(1-deoxy-D-fructos-1-yl)hippuryl-lysine, was synthesized to investigate the degradation pathways of the sugar moiety. The labeled compound was then incubated under aerobic and physiologic conditions, followed by analysis using 13C-NMR spectroscopy to obtain the degradation profile. Consequently, after 28-d incubation at least nine 13C signals due to 13C-labeled products were observed with those due to unlabeled hippuryl-lysine. These labeled products included not only carboxymethylated hippuryl-lysine as the major product and alpha- and beta-glucose but also acetate and formate. These experiments demonstrate the potential of using a 13C label and NMR spectroscopy in that the technique provides the comprehensive profiling of the degradation products containing the labeled position in spite of their chemical structures.

Carbon Isotopes↗
PubMed1989

Degradation of 2-carboxyarabinitol 1-phosphate by a specific chloroplast phosphatase.

The catalytic degradation of 2-carboxyarabinitol 1-phosphate (CA 1-P), a naturally occurring inhibitor of ribulose-1,5-bisphosphate carboxylase/oxygenase (Rubisco), was investigated by chromatographic and spectroscopic analyses of the reaction products. Carboxy-labeled [(14)C]CA 1-P was incubated with a partially purified tobacco (Nicotiana rustica) chloroplast protein that has been shown previously to catalyze metabolism of CA 1-P to a form incapable of inhibiting Rubisco (ME Salvucci, GP Holbrook, JC Anderson, and G Bowes [1988] FEBS Lett 231: 197-201). In the presence and absence of NADPH, ion-exchange chromatography showed a progressive conversion of [2'-(14)C]CA 1-P to a labeled compound which coeluted with authentic carboxyarabinitol. Parallel assays with unlabeled CA 1-P showed a concomitant decrease in the ability of reaction samples to inhibit Rubisco activity. In separate experiments, a 1:1 stoichiometry was found between the release of inorganic phosphate from [2'-(14)C]CA 1-P and accumulation of the (14)C-labeled product. Liberation of inorganic phosphate was not observed when the tobacco enzyme was incubated with ribulose-1,5-bisphosphate, fructose-1,6-bisphosphate, glucose-1-phosphate, glucose-6-phosphate, or 6-phosphogluconate. Proton nuclear magnetic resonance spectroscopy of the labeled CA 1-P reaction product established its identity as carboxyarabinitol. We therefore propose that light-stimulated degradation of CA 1-P is catalyzed in vivo by a specific phosphatase, 2-carboxyarabinitol 1-phosphatase. Carboxyarabinitol 1-phosphatase activity was detected in the absence of NADPH, but increased threefold when 2 millimolar NADPH was present. Thus, while not required for the reaction, NADPH may play an important role in the regulation of CA 1-P degradation.

Journal Article↗
PubMed1992

Carbon dioxide fixation in neuronal and astroglial cells in culture.

The concentration of potassium in the extracellular fluid has been found to stimulate the rate of CO2 fixation by astroglial cells grown in primary culture. Raising the concentration of extracellular potassium increased both the initial rate of formation of the 14C-labeled products of 14CO2 fixation and the final steady-state level of these products within the cells. In contrast, neither veratridine nor L-glutamate affected the rate of CO2 fixation in astroglial cells. The very low rate of CO2 fixation found in primarily neuronal cultures was unaffected by increased extracellular potassium as was CO2 fixation in fibroblasts. When cultured alone, astroglial cells release a large fraction of the 14C-labeled products of CO2 fixation into the surrounding medium. Mixed cultures of astroglia and neurons also fix CO2 but, in contrast to astroglia cultured alone, release only a small fraction of the 14C-labeled products into the culture medium.

Animals↗
PubMed2000

In vitro biosynthesis of 1,4-beta-galactan attached to rhamnogalacturonan I.

The biosynthesis of galactan was investigated using microsomal membranes isolated from suspension-cultured cells of potato (Solanum tuberosum L. var. AZY). Incubation of the microsomal membranes in the presence of UDP-[14C]galactose resulted in a radioactive product insoluble in 70% methanol. The product released only [14C]galactose upon acid hydrolysis. Treatment of the product with Aspergillus niger endo-1,4-beta-galactanase released 65-70% of the radioactivity to a 70%-methanol-soluble fraction. To a minor extent, [14C]galactose was also incorporated into proteins, however these galactoproteins were not a substrate for Aspergillus niger endo-1,4-beta-galactanase. Thus, the majority of the 14C-labelled product was 1,4-beta-galactan. Compounds released by the endo-1,4-beta-galactanase treatment were mainly [14C]galactose and [14C]galactobiose, indicating that the synthesized 1,4-beta-galactan was longer than a trimer. In vitro synthesis of 1,4-beta-galactan was most active with 6-d-old cells, which are in the middle of the linear growth phase. The optimal synthesis occurred at pH 6.0 in the presence of 7.5 mM Mn2+. Aspergillus aculeatus rhamnogalacturonase A digested at least 50% of the labelled product to smaller fragments of approx. 14 kDa, suggesting that the synthesized [14C]galactan was attached to the endogenous rhamnogalacturonan I. When rhamnogalacturonase A digests of the labelled product were subsequently treated with endo-1,4-beta-galactanase, radioactivity was not only found as [14C]galactose or [14C]galactobiose but also as larger fragments. The larger fragments were likely the [14C]galactose or [14C]galactobiose still attached to the rhamnogalacturonan backbone since treatment with beta-galactosidase together with endo-1,4-beta-galactanase digested all radioactivity to the fraction eluting as [14C]galactose. The data indicate that the majority of the [14C]galactan was attached directly to the rhamnose residues in rhamnogalacturonan I. Thus, isolated microsomal membranes contain enzyme activities to both initiate and elongate 1,4-beta-galactan sidechains in the endogenous pectic rhamnogalacturonan I.

Cells, Cultured↗
PubMed2003

Simplified method to substantiate SPF labeling for sunscreen products.

BACKGROUND/PURPOSE: Worldwide, sunscreen sun protection factor (SPF) testing is based on 30-year-old technology. At the time the SPF test came into being, the highest SPFs available were in the 6-8 range. The SPF test is reasonably accurate for SPFs up to 15, but is much less reliable for measuring SPFs of 30 and higher. The method we propose addresses two primary reasons for this unreliability: 1) difficulties in applying products uniformly and 2) the subjectivity and variability of perception in evaluating and grading responses to UV doses. METHODS: Our proposed SPF substantiation method differs from the current SPF test in that sunscreen-protected test sites receive the same UV dose in four uniformly spaced sub-sites, which are graded as passing if no response is seen or failing if any response is seen. The response may be tanning, erythema, or a combination of both. To demonstrate the method, two commercial products with labeled SPFs of 30 and 45 and the P2 sunscreen standard were tested at two different laboratories. RESULTS: The SPF 30 product and SPF 15 standard were shown to be correctly labeled. However, it is questionable as to whether the SPF 45 product provides protection against 45 minimal erythema doses. CONCLUSIONS: Our proposed SPF substantiation method is not dependent on subjective evaluation of responses, accounts for non-uniform product application, and provides a conservative estimate of sunscreen protection. The method consists of a systematic repetition of identical tests that are considerably more rigorous than the current methods that are based on single data points per test subject. While the current SPF test remains necessary and valuable as a dose ranging tool, we propose that this SPF substantiation method supersede the old method for final SPF label determination.

Administration, Cutaneous↗
PubMed2004

Application of an empiric Bayesian data mining algorithm to reports of pancreatitis associated with atypical antipsychotics.

STUDY OBJECTIVE: To compare the results from one frequently cited data mining algorithm with those from a study, which was published in a peer-reviewed journal, that examined the association of pancreatitis with selected atypical antipsychotics observed by traditional rule-based methods of signal detection. DESIGN: Retrospective pharmacovigilance study. INTERVENTION: The widely studied data mining algorithm known as the Multi-item Gamma Poisson Shrinker (MGPS) was applied to adverse-event reports from the United States Food and Drug Administration's Adverse Event Reporting System database through the first quarter of 2003 for clozapine, olanzapine, and risperidone to determine if a significant signal of pancreatitis would have been generated by this method in advance of their review or the addition of these events to the respective product labels. MEASUREMENTS AND MAIN RESULTS: Data mining was performed by using nine preferred terms relevant to drug-induced pancreatitis from the Medical Dictionary for Regulatory Activities (MedDRA). Results from a previous study on the antipsychotics were reviewed and analyzed. Physicians' Desk References (PDRs) starting from 1994 were manually reviewed to determine the first year that pancreatitis was listed as an adverse event in the product label for each antipsychotic. This information was used as a surrogate marker of the timing of initial signal detection by traditional criteria. Pancreatitis was listed as an adverse event in a PDR for all three atypical antipsychotics. Despite the presence of up to 88 reports/drug-event combination in the Food and Drug Administration's Adverse Event Reporting System database, the MGPS failed to generate a signal of disproportional reporting of pancreatitis associated with the three antipsychotics despite the signaling of these drug-event combinations by traditional rule-based methods, as reflected in product labeling and/or the literature. These discordant findings illustrate key principles in the application of data mining algorithms to drug safety surveillance. CONCLUSION: The optimal place of data mining algorithms in the pharmacovigilance tool kit remains to be determined, requires consideration of numerous factors that may affect their performance, and is highly situation dependent.

Adverse Drug Reaction Reporting Systems↗
PubMed2002

Variations in parthenolide content and daily dose of feverfew products.

Variations in the parthenolide content of feverfew products available to consumers were studied. Feverfew products were analyzed for the content of parthenolide, the purported active component. The actual weight of feverfew was determined only in those products containing dried feverfew leaf. The total daily doses of feverfew leaf and parthenolide were calculated by using the instructions on each product label. Parthenolide content was determined by high-performance liquid chromatography. The quantity of feverfew leaf in each capsule was similar to that stated on the label and ranged from 25 to 500 mg. Parthenolide content per dosage form varied 150-fold (from 0.02 to 3.0 mg), while percent parthenolide varied 5.3-fold (from 0.14% to 0.74%). If a person consumed the daily dose recommended on the label, intake of dried feverfew leaf would range from 225 to 2246 mg/day, a 10-fold variation, while intake of parthenolide would range from 0.06 to 9.7 mg/day, a 160-fold variation. Large variations were observed in the parthenolide contents and daily intake as recommended by the labeling in commercial feverfew products.

Capsules↗
PubMed2001

Participation of racial/ethnic groups in clinical trials and race-related labeling: a review of new molecular entities approved 1995-1999.

Few recent data are available from formal evaluations of approved new drug applications to address perceptions that racial and ethnic groups are under-represented in clinical trials of new drugs. This study reviews racial and ethnic group participation in clinical trials and race-related labeling for new molecular entities approved during a five-year period by the Food and Drug Administration's (FDA) Center for Drug Evaluation and Research (CDER). This was a retrospective review of FDA medical officers' reviews of clinical trial protocols and product labeling for 185 new molecular entities (NME's) approved by CDER between January 1,1995, and December 31, 1999. Enrollment data were obtained from the reviews and tabulated according to race/ethnicity. The approved product labeling was searched for statements related to product testing in various racial/ethnic groups. All data were compiled and analyzed using Microsoft Access. This study quantifies the participation of racial/ethnic groups in clinical trials by year and therapeutic category. Additionally, the study categorizes labeling based on the types of effects described as related to race/ethnicity. Racial and ethnic groups appear to participate in clinical trials to varying degrees. African Americans participated in trials to the greatest extent; however, their participation steadily declined from 12% in 1995 to 6% in 1999. Among trials known to be conducted only in the U.S., African-American participation is comparable to their representation in the U.S. population. In all cases, participants designated as Hispanic appear to be far below their representation in the population. Some differences in participation for all racial and ethnic groups are seen when comparisons from year-to-year or among drug classes are made. Labeling for 45% (84/185) of the products contained some statement about race, although in only 8% (15/185) were differences related to race described. Fifty percent (50%) of the effects were pharmacokinetic, 39% were efficacy, and 11% were safety. One product label recommended a change in dosage based on racial differences.

Clinical Trials as Topic↗