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PubMed2003

A multicenter, randomized, open-label, comparative, two-period crossover trial of preference, efficacy, and safety profiles of a prefilled, disposable pen and conventional vial/syringe for insulin injection in patients with type 1 or 2 diabetes mellitus.

BACKGROUND: The accuracy and convenience of pen devices for insulin injection have improved quality of life for patients with insulin-treated diabetes mellitus (DM). Prefilled, disposable pens have the advantage of simplicity, with minimal training and attention required and no installation of new cartridges necessary. OBJECTIVE: The aim of this study was to assess patient preference, efficacy, and safety profiles of a prefilled, disposable pen (FlexPen) and conventional vial/syringe injection method for insulin injection therapy among patients with DM. METHODS: In a multicenter, randomized, open-label, crossover study, patients with type 1 or 2 DM were transferred from previous QD or BID conventional insulin therapy to a mixture of 70% insulin aspart protamine suspension and 30% insulin aspart injection (NovoLog Mix 7030) for 4 weeks of dose optimization using their usual type of syringe. Patients were then randomly assigned to use either vial/syringe or a prefilled, disposable pen to inject the biphasic insulin aspart 7030 mixture for the next 4 weeks, followed by 4 weeks of use of the other injection device. Efficacy, safety profiles, and patient preference for the delivery systems were compared. RESULTS: A total of 121 patients (mean [SD] age, 57.0 [12.4] years; age range, 28-81 years; mean [SD] body mass index, 31 [5.5] kg/m(2)) were enrolled. One hundred three patients completed the study. Seventy-four percent of patients (78105) indicated a preference for the pen over the vial/syringe method (95% CI, 71%-87%), compared with 20% (21105) who preferred the vial/syringe. Eighty-five percent (88104) considered the pen more discreet for use in public (compared with 9% [9104] for the vial/syringe), 74% (77104) considered it easier to use overall (compared with 21% [22104] for the vial/syringe), and 85% (89105) found the insulin dose scale on the pen easier to read (compared with 10% [10105] for the vial/syringe). Patients had statistically significant improvement in glycosylated hemoglobin values during the study (P < 0.05). No statistically significant differences in fasting plasma glucose, mean 4-point blood glucose profiles, or serum fructosamine values were found between groups. Overall, the safety profiles during treatment periods with the pen were comparable to those with the vial/syringe. CONCLUSIONS: In this trial, differences in efficacy and safety profiles between the vial/syringe and prefilled, disposable pen appeared negligible. However, more patients expressed a preference to continue use of the pen.

Adult↗
PubMed1998

The pre-morbid psychometric profile is stable over time in subjects at high familial risk for affective disorders.

BACKGROUND: The pre-morbid personality profile 'autonomic lability' (e.g. elevated neuroticism, frequent somatic complaints and increased interpersonal sensitivity) is suggested to be an antecedent of major depression. Recently, we reported that the psychometric profile of healthy first-degree relatives of patients with an affective disorder (so-called high-risk probands; HRPs) was characterized by the personality trait 'rigidity' in association with 'autonomic lability' and speculated that such a profile might be a potential candidate for a true vulnerability marker for affective disorders. Because one major prerequisite for any valid vulnerability marker is its stability over time, we re-examined our HRPs about four years after index assessment. METHODS: Sixteen HRPs from the initial sample (n=54) participated in the follow-up investigation which, on average, took place 47 months after index assessment. All these HRPs had remained mentally healthy during the follow-up period. RESULTS: The psychometric profile was remarkably stable over the four-year period when considering the total group of the 16 HRPs. On an individual level, similar findings were obtained. Allowing a fluctuation within a narrowly defined 'band width', a constancy of the self-ratings was found in 75% of the HRPs, within a broader 'band width' this was the case in 88% of the HRPs. LIMITATIONS: The power of the present observations appears to be somewhat limited due to the still small sample size of HRPs re-investigated and the fact that the control probands were not yet re-examined. CONCLUSIONS: The present follow-up findings in 16 probands at high risk for an affective disorder indicate a sufficient stability of the psychometric profile over time, so that this requirement for a true vulnerability marker is fulfilled.

Adult↗
PubMed1999

Nonparametric analysis of the absorption profile of octreotide in rabbits from long-acting release formulation OncoLAR.

Octreotide (octreotide-acetate, Sandostatin(R)) is a somatostatin analogue, used in long-term treatment of acromegaly. The present study describes the absorption profile in rabbits of octreotide after release from the long-acting formulation OncoLAR (denoted as octreotide-LAR). In a first experiment, the disposition kinetics of octreotide was studied for 24 h in six rabbits after intravenous (i. v.) injection of 0.025 mg of a solution of octreotide. In a second experiment, release kinetics was studied in eight rabbits for 49 days after an i.m. injection of 5 mg/kg of octreotide-LAR. Concentrations were determined by radioimmunoassay. After i.v. injection of octreotide, one- and two-compartment models were compared for each rabbit. A typical disposition profile was computed using the mean parameters. After i.m. injection of octreotide-LAR, deconvolution was performed using the point-area method. Individual absorption profiles were characterised using natural splines. The number of breakpoints was selected using the generalised cross-validation criterion. The two compartment model was selected based on the i.v. study. After i.m. administration, octreotide exhibited a triphasic absorption profile, with large interindividual variability. A transient peak followed the initial burst phase. The third phase covered 85% of total drug released. The approach allows a model-independent description of the in vivo absorption profile of octreotide-LAR.

Absorption↗
PubMed1994

Antimitochondrial antibody profiles in patients with primary biliary cirrhosis before orthotopic liver transplantation and titres of antimitochondrial antibody-subtypes after transplantation.

Four antimitochondrial antibody profiles (A-D) have been defined in primary biliary cirrhosis according to the presence of antibodies to M2, M4, M8, and M9 in ELISA and the complement fixation test: A: anti-M9 positive in ELISA and western blot, B: anti-M9 and/or anti-M2 positive in ELISA, C: anti-M2, -M4 and/or -M8 positive in ELISA, D: anti-M2, -M4, and/or -M8 positive in ELISA and complement fixation test. These profiles predict the outcome of primary biliary cirrhosis in the early stages and reflect differences in the natural course of the disease (benign versus progressive). In this study sera from 29 patients with advanced primary biliary cirrhosis who had received liver transplant were retested before and after orthotopic liver transplantation. Twenty-eight were antimitochondrial antibody/anti-M2 positive, and one patient had only antibodies to nuclear dots in the immunofluorescence test on cell cultures. When the antimitochondrial antibody-profiles in these 28 anti-M2 positive patients were analysed, it became evident that 26 of them belonged to subgroup C or D before orthotopic liver transplantation. Two patients had profile B; one had high titres of antinuclear and smooth muscle antibodies indicating an overlap syndrome between primary biliary cirrhosis and autoimmune chronic active hepatitis. The other patient had antibodies to nuclear dots in association with anti-M2. None of the patients had profile A. Antibody titres were studied after orthotopic liver transplantation in 23 of the 28 patients who survived for 1 to 13 years.(ABSTRACT TRUNCATED AT 250 WORDS)

Adult↗
PubMed2003

Stump/socket pressure profiles of the pressure cast prosthetic socket.

OBJECTIVE: The aim was to evaluate stump/socket interface pressure in amputees wearing a socket developed by a pressure casting system.Design. Five unilateral transtibial amputees wore a pressure cast socket and walked at a self-selected speed. BACKGROUND: The socket produces equally distributed pressure at the stump/socket interface, deviating from the conventional belief that pressure varies in proportion to the pain threshold of different tissues in the stump. METHODS: The socket was fabricated while the subject placed his stump in a pressure chamber. Pressure was applied while he adopted a normal standing position. A specially built strain gauged type pressure transducer was used for measuring pressure distribution. Pressure and gait parameters were measured simultaneously while the subjects were standing and walking. RESULTS AND CONCLUSION: The pressure cast technique was able to provide comfortable fitting sockets. A hydrostatic pressure profile was not evident during standing or gait. Results also showed that no standard pressure profile for the pressure cast socket was observed. This was expected as no rectifications were done on the pressure cast socket. Pressure profiles at 10%, 25% and 50% of gait cycle did not correlate with the pressure profiles previously proposed. RELEVANCE: The hydrostatic theory is an attractive concept in socket design as it produces a stump/socket pressure profile that is evenly distributed. Furthermore, it is a method that is easily implemented, independent of a prosthetist's skill and experience and reduces manufacturing time. However, there is still controversy surrounding the efficacy of this hydrostatic theory.

Adult↗
PubMed1991

Suppression of renal vein renin profiles by mannitol prophylaxis: implications in the evaluation of renovascular hypertension.

Renal arteriography with concomitant renal vein renin profiling remains the diagnostic standard for evaluating the anatomic and physiologic significance of stenotic renal artery lesions in hypertensive patients. False-negative renal vein renin profiles with failure of lateralization in patients with anatomically apparent high-grade stenosis complicate the diagnostic process. Mannitol is frequently administered prophylactically to minimize the risk of dye nephropathy in these patients. Yet, the potential effects of mannitol on renal vein renin profiling in man have not been previously reported. Seven patients with renovascular hypertension were studied prospectively to determine changes in renal vein renin profiles before and after mannitol prophylaxis. Despite captopril stimulation, all patients demonstrated significant renin suppression leading to the loss of renin lateralization in patients with unilateral renovascular hypertension. In 60% of the patients, renal vein renin ratios fell to below the standard 1.5 to 1 ratio after mannitol infusion. In patients with bilateral renovascular disease, the least stenotic side suppressed completely, while the more stenotic side suppressed partially. Percent suppression analysis showed a mean suppression of 56.8% on the stenotic side versus 8.2% on the noninvolved side (P less than 0.002). In every study, suppression equaled or exceeded 32% on the involved side and was less than this on the noninvolved side. Thus, the degree of renin suppression following mannitol infusion may prove to be an important tool in the diagnosis of clinically significant stenotic lesions. The mechanism of mannitol-induced suppression remains undefined, but appears independent of volume expansions or dilutional effects. The inhibitory effects of mannitol on renin profiles can obscure the diagnosis of underlying renovascular hypertension.

Adult↗
PubMed1990

The role of pharmacological profiling in safety assessment.

The profiling of new drug candidates for general pharmacological properties requires a systematic examination of the functional effects of agents in a variety of in vitro and in vivo assays. Both the behavioral and physiological consequences of drug treatment are monitored in models of central nervous system, cardiovascular, autonomic, gastrointestinal, and renal functions. Broad functional profiling provides valuable information to the preclinical pharmacologist with respect to the selectivity of new agents and may serve to identify new and useful therapeutic indications of investigational drugs. At the same time, knowledge of the effects on these physiological systems can also play an important role in safety assessment. Pharmacological activity of a new agent that is both unintended and undesirable can be referred to as "pharmacological toxicity." In general, the spectrum of toxicities disclosed in pharmacological profiling includes a variety of acute functional or physiological effects which are not life-threatening and are readily reversible. On rare occasions, unanticipated and life-threatening pharmacological effects (e.g., convulsions, arrhythmias) are detected which can seriously detract from the usefulness of a new agent and may therefore deter the drug development process. It should also be noted that repeated exposure to acute pharmacological effects may lead to less obvious chronic findings, such as target organ effects or tumor formation in animals. The interpretation of pharmacological toxicity with respect to the safety profile of a new drug candidate is dependent not only upon the types of reactions observed and the doses at which they occur but also upon the nature of the effects elicited as to whether they represent expected extensions of the primary mechanism of action of a compound or constitute reactions unrelated to the primary pharmacological activity. The ultimate impact of pharmacological toxicity, as with all adverse findings in preclinical assessment, is dependent upon the projected therapeutic margin of safety as well as the risk-to-benefit ratio for new drug entities. In addition to supplementing the existing armamentarium of preclinical safety studies, pharmacological profiling can also play an important role in (1) the selection of new drug candidates with reduced toxic potential, (2) the design and conduct of preclinical toxicology studies, (3) the investigation of preclinical and clinical safety issues, and (4) the identification of potential functional effects to be monitored most closely in clinical trials of new drug entities.

Animals↗
PubMed2000

Soft tissue profile changes after autogenous iliac crest onlay grafting for the extremely atrophic maxilla.

PURPOSE: The aim of this study was to evaluate profile changes in the hard and soft tissues after onlay grafting in the extremely atrophic maxilla. PATIENTS AND METHODS: Onlay grafting using autogenous iliac crest bone grafts was performed in 49 patients (42 females and 7 males) with extreme atrophy of the edentulous maxilla (vertical amount of bone: <6 mm, transverse amount of bone: <5 mm). For the assessment of the changes to the hard and soft tissues, the preoperative and postoperative cephalograms were traced and the cephalometric measuring points (44 skeletal and 25 soft tissue points) were digitalized with the aid of the Dentofacial Planner System. Evaluation of a relationship between soft tissue and hard tissue profile changes was performed by comparing the movement of the skeletal points Sub-ANS and A-point with the shift of the soft tissue point SLS. To determine significant hard tissue and soft tissue changes, the measured values were evaluated using the SPSS program system and examined for statistical significance by use of the Wilcoxon test. RESULTS: An advancement of the bony maxilla profile in the sagittal direction by an average of 2.4 mm (P < .01) was found. The soft tissue profile of the upper lip was moved forward on average by 2.3 mm (P = .0039) at the superior labial sulcus point and by 2.7 mm (P = .0018) at the labrale superius point. The ratio of the soft tissue change to hard tissue change was 0.7:1 (superior labial sulcus: skeletal point sub-ANS) or 0.9:1 (superior labial sulcus: A point). CONCLUSIONS: When planning onlay graft operations, consideration should be given to the functional and aesthetic effects of the profile changes on the upper lip.

Adult↗
PubMed1983

Comparison of two methods of profile prediction in surgical treatment of mandibular prognathism.

Two methods for prediction of the soft tissue profile subsequent to oblique subcondylar osteotomy for correction of mandibular protrusion were evaluated. The first one included distalization of the mandible into an Angle Class I relationship. The amount of distalization and any vertical changes were transferred to the tracing, and the anticipated new profile was drawn. The second method was based on the profile means of a group of "normal" persons and was aimed at correction of both sagittal and vertical discrepancies. Fifty patients were studied. A double set of prediction tracings was made according to both methods; and the results were compared with the actual postoperative results and with a "normal" control group. Both methods were usable, as the predictions were considered satisfactory if they were within one standard deviation from the mean of the control group. The sagittal changes were somewhat exaggerated by both analyses. The vertical changes were much better expressed by the profile prediction. Such changes are difficult to create by the vertical subcondylar osteotomy. Consequently, the model prediction seems most suitable for planning profile changes in surgical techniques that include mobilization of one main mandibular fragment.

Adult↗
PubMed2002

Receptor profile of P88-8991 and P95-12113, metabolites of the novel antipsychotic iloperidone.

Iloperidone is a novel atypical antipsychotic compound currently under clinical development for the treatment of psychotic disorders. In radioligand binding studies, iloperidone binds with high affinity to serotonin (5-HT) 5-HT2A and noradrenaline alpha1 and alpha2C receptors [Neuropsychopharmacology (2001) 25, 904-914]. The human metabolism of iloperidone generates two major metabolites, P88-8991 and P95-12113. The aim of this study was to compare the receptor affinity profile of P88-8991 and P95-12113 with that of the parent compound. The receptor affinity profile of P88-8991 is comparable to that of iloperidone. This metabolite binds to the following monoamine receptors (pKi values in nM): serotonin 5-HT2A receptors (9.56), adrenergic alpha1 (8.08) and alpha2C (7.79) receptors, and D2A receptors (7.80). Lower affinity is seen for other dopamine, serotonin, alpha2-adrenergic and histamine H1 receptors. In contrast, P95-12113 shows affinity for 5-HT2A receptors (pKi 8.15; which is 60-fold lower than that of iloperidone), adrenergic alpha1 (7.67), alpha2C (7.32) and alpha2B (7.08) receptors. Given this affinity profile, and the observation that P95-12113 does not readily cross the blood-brain barrier, it is unlikely that this metabolite contributes to the therapeutic effect of iloperidone in patients with schizophrenia. However, the comparable receptor binding profile of P88-8991 indicates that it is likely to contribute to the clinical profile of iloperidone.

3T3 Cells↗
PubMed2001

The effect of steroids on the biophysical profile and Doppler indices of umbilical and middle cerebral arteries in healthy preterm fetuses.

OBJECTIVE: To examine the effect of antenatal steroids on the biophysical profile and the Doppler parameters of umbilical and middle cerebral arteries of healthy fetuses. STUDY DESIGN: Thiry-five singleton pregnancies between the gestational ages of 28 and 34 weeks, who received two consecutive doses of betamethasone 24h apart to accelerate pulmonary maturation were prospectively studied. Fetal biophysical profile and Doppler assessment were performed at 0 (pre-steroid), 24, 48, 72, 96 and 120 h after the administration of first dose. We compared the percentage of the fetuses with biophysical parameters present for each of the five components of the biophysical profile and the Doppler indices, using Cochran's Q-test, Friedman's test and one way analysis of variance of repeated measures where appropriate. The statistical significance was defined as P<0.05. RESULTS: The mean delivery time was 36.9(+/-1.8) weeks. There was a statistically significant difference in the frequency of the following findings in the pre- compared to post-steroid measurements: absence of body movements (48 h, P<0.05), non-reassuring fetal heart rate tracings (24, 48 and 72 h, P<0.05) and absence of breathing movements (24, 48 and 72 h, p<0.05). Initially none of the biophysical profile score was <or=6, whereas at 24, 48 and 72 h, 13.3, 76.7, 16.7% of them, respectively, were <or=6 (P<0.05). None of the Doppler indices was found to be affected by the steroid administration. CONCLUSION: Maternal betamethasone administration can cause a significant but transient, reduction in biophysical profile scores, however the middle cerebral and umbilical artery Doppler indices were found to be unaffected suggesting the reliability of this modality for the evaluation of the fetuses previously exposed to the antenatal steroids.

Adult↗
PubMed2002

Contribution of solvent water to the solution X-ray scattering profile of proteins.

A theoretical framework is presented to analyze how solvent water contributes to the X-ray scattering profile of protein solution. Molecular dynamics simulations were carried out on pure water and an aqueous solution of myoglobin to determine the spatial distribution of water molecules in each of them. Their solution X-ray scattering (SXS) profiles were numerically evaluated with obtained atomic-coordinate data. It is shown that two kinds of contributions from solvent water must be considered to predict the SXS profile of a solution accurately. One is the excluded solvent scattering originating in exclusion of water molecules from the space occupied by solutes. The other is the hydration effect resulting from formation of a specific distribution of water around solutes. Explicit consideration of only two molecular layers of water is practically enough to incorporate the hydration effect. Care should be given to using an approximation in which an averaged electron density distribution is assumed for the structure factor because it may predict profiles considerably deviating from the correct profile at large K.

Animals↗
PubMedDate not supplied

Semiconductor dopant profiling by off-axis electron holography.

Silicon wafers with a complex but known dopant profile were used to explore possible methods for improving the reliability of off-axis electron holography for quantitative determination of electrostatic potential profiles in doped semiconductor devices. The variability of results from nominally identical structures was attributed to local charging and associated external fields, forcing the development of a more robust approach to hologram analysis that incorporated an additional phase correction factor rather than rely on vacuum for phase flattening. Consistent results in close agreement with simulated profiles based on measured dopant distributions could then be obtained. Carbon coating was shown to be effective in reducing accumulation of charge caused by emission of secondary electrons. Overall, this work demonstrates that reliable potential profiles from unbiased samples should be obtainable on a routine basis provided that regions suitable for flattening of the phase profile can be identified.

Journal Article↗
PubMed2002

C1 adrenergic neurons are contacted by presynaptic profiles containing DELTA-opioid receptor immunoreactivity.

Ligands of the delta-opioid receptor tonically influence sympathetic outflow. Some of the actions of delta-opioid receptor agonists may be mediated through C1 adrenergic neurons in the rostral ventrolateral medulla. The goal of this study was to determine whether C1 adrenergic neurons or their afferents contain delta-opioid receptors. Single sections through the rostral ventrolateral medulla were labeled for delta-opioid receptor using the immunoperoxidase method and the epinephrine synthesizing enzyme phenylethanolamine N-methyltransferase (PNMT) using the immunogold method, and examined at the light and electron microscopic level. Few ( approximately 5% of 903) profiles dually labeled for PNMT and delta-opioid receptor were detected; most of these were dendrites with diameters < 1.5 microm. delta-Opioid receptor immunoreactivity was affiliated with multivesicular bodies in dually labeled perikarya, whereas delta-opioid receptor immunoperoxidase labeling appeared as isolated clusters within both singly and dually labeled dendrites. The majority ( approximately 83% of 338) of delta-opioid receptor-immunoreactive profiles were axons and axon terminals. delta-Opioid receptor-immunoreactive terminals averaged 0.75 microm in diameter, contained numerous large dense-core vesicles and usually formed appositions or asymmetric (excitatory-type) synapses with their targets. The majority (>50% of 250) of delta-opioid receptor-immunoreactive axons and axon terminals contacted PNMT-immunoreactive profiles. Most of the contacts formed by delta-opioid receptor-immunoreactive profiles ( approximately 75% of 132) were on single-labeled PNMT-immunoreactive dendrites with diameters <1.5 microm. The prominent localization of delta-opioid receptors to dense-core vesicle-rich presynaptic profiles suggests that delta-opioid receptor activation by endogenous or exogenous agonists may modulate neuropeptide release. Furthermore, the presence of delta-opioid receptors on axon terminals that form excitatory-type synapses with PNMT-immunoreactive dendrites suggests that delta-opioid receptor ligands may modulate afferent activity to C1 adrenergic neurons. The observation that some PNMT-immunoreactive neurons contain delta-opioid receptor immunoreactivity associated with multivesicular bodies and other intracellular organelles suggests that some C1 adrenergic neurons may present, endocytose and/or recycle delta-opioid receptors.

Animals↗
PubMed1997

Flagellin, a major protein present in SDS-PAGE profiles of Sarkosyl-OMP-enriched fractions from Bordetella bronchiseptica Bvg- or modulated Bvg+ strains.

The bvg or vir locus positively regulates the expression of many Bordetella virulence-associated determinants (encoded by vag genes), including cell envelope proteins, in response to environmental stimuli. On the other hand, several genes named vrg genes are negatively controlled by the bvg regulon (Knapp and Mekalanos, 1988). Flagellin is encoded by a vrg gene, which is expressed when the principal virulence factors are eliminated during antigenic modulation or in phase variants (Akerley et al., 1992). We have previously analyzed SDS-PAGE profiles of Sarkosyl-outer membrane protein (OMP)-enriched fractions from B. bronchiseptica Bvg- and modulated Bvg+ strains and reported a major band associated with the avirulent phenotype (Passerini de Rossi et al., 1995). In order to characterize this band we have purified flagellar filaments from Bvg- and modulated Bvg+ strains, and analyzed them by SDS-PAGE. These profiles revealed a single major band of 40 or 45 kDa depending on the strain. The N-terminal amino acid sequence of the putative flagellin expressed by BB7200a was identical over the first 21 residues analyzed to that of the flagellin from the modulated strain BB7865 reported by Akerley et al. (1992). Comparison of the SDS-PAGE profile of flagellar filaments with that of the OMP-enriched fraction of the corresponding strain showed that the flagellum-associated polypeptide had the same electrophoretic mobility as that of the characteristic band of the avirulent phenotype. Furthermore, this band was absent in the OMP-enriched fraction profile from a Bvg- strain subjected to a treatment that removes flagella. Our results indicate that the major protein observed in SDS-PAGE profiles of Sarkosyl-OMP-enriched fractions from B. bronchiseptica Bvg- and modulated Bvg+ strains corresponds to flagellin.

Amino Acid Sequence↗
PubMed2002

Temporal changes in cytokine gene expression profiles induced in mice by trimellitic anhydride.

Prolonged (13 day) topical exposure of BALB/c strain mice to the chemical respiratory allergen trimellitic anhydride (TMA) induces a selective T helper (Th) 2 profile of cytokine secretion in cells isolated from the draining lymph node. The ability of chemical respiratory allergens to elicit preferential type 2 immune responses is a distinguishing characteristic and provides the theoretical basis for cytokine fingerprinting, a novel approach to hazard identification. This study aimed to further characterize the cytokine expression profile induced by TMA, and to investigate the kinetics of cytokine production at both the protein and mRNA level by comparison of acute (3 day) and chronic (13 day) exposure regimes. Acute exposure resulted in the expression of high levels of mRNA for both Th1- and Th2-type cytokines, including interleukins 4, 10, 15 (IL-4, IL-10, IL-15) and interferon gamma (IFN-gamma), and the inflammatory cytokine IL-6, as determined by ribonuclease protection assay (RPA). However, following chronic exposure marked down-regulation of message for IL-6 and IFN-gamma was observed along with concomitant up-regulation of IL-4 and IL-10 expression. These cytokine mRNA profiles were broadly paralleled at the protein level. There was also a marked increase with time of mRNA for the Th2 cytokine IL-9, a cytokine not associated previously with chemical allergy. These data show that as the immune response to TMA develops, the cytokine gene expression profile of allergen-activated lymph node cells evolves from a mixed Th1/Th2 phenotype to a more polarized Th2 profile.

Animals↗
PubMed2000

Comparison of in vitro dissolution profiles by ANOVA-based, model-dependent and -independent methods.

In this study, the aim was to apply different comparison methods to dissolution profiles of immediate release commercial film-coated tablets of naproxen sodium in order to (1) evaluate each method in terms of easy application and usefulness and (2) identify the advantages and disadvantages of each method. Dissolution testing was conducted using the USP monograph of naproxen sodium. The applied methods for the comparison of in vitro dissolution profiles are ANOVA-based methods, model-dependent methods, and model-independent methods including difference factor, f(1), and similarity factor, f(2). All the methods appear to be applicable and useful in comparing dissolution profiles. The results show that ANOVA-based methods and model-dependent methods are more discriminative than the f-factors. f-Factors seem to be easier to apply and interpret; only one value is obtained to describe the closeness of the two dissolution profiles. However, a last point for dissolution had to be determined, since the values of the f-factors depend on this point. The application and evaluation of model-dependent methods are more complicated; these methods present an acceptable model approach to the true relationship between percent dissolved and time variables, including statistical assumptions which could be checked. Dissolution profiles can be tested for differences in both level and shape by ANOVA-based methods and these methods provide detailed information about dissolution data which can be useful also in formulation development to match release to a reference product.

Algorithms↗
PubMed2002

Inversion profiles of adiabatic inversion pulses for flowing spins: the effects on labeling efficiency and labeling accuracy in perfusion imaging with pulsed arterial spin-labeling.

The inversion profile of adiabatic inversion pulses is essential to the accuracy of perfusion measurement with pulsed arterial spin-labeling (ASL). In this paper, the inversion profiles for flowing spins were investigated using a numerical solution of the modified Bloch equations including a term for moving spins. Inversion profiles for spins flowing at a constant or varying velocity were examined for hyperbolic secant (HS) and frequency-offset corrected inversion (FOCI) pulses. Distortions of the inversion profiles were found for both pulses with spins flowing within physiological velocity range. The effects of the distorted profiles on labeling efficiency and labeling accuracy in the application of pulsed ASL perfusion imaging were analyzed. These effects should be taken into account in ASL techniques, in order to obtain robust and accurate perfusion measurements.

Blood Flow Velocity↗