Equivalent Limit Research Articles

An evaluation of the drug interaction potential of netupitant with digoxin.

e19530 Background: The new, highly selective neurokinin-1 receptor antagonist netupitant (NETU) has been developed to provide protection from nausea and vomiting in patients receiving emetogenic chemotherapy. There is evidence from in vitro studies that NETU is a substrate for and a weak inhibitor of the P-glycoprotein (Pgp). Pgp plays a major role in the pharmacokinetics of digoxin (DIG), a cardiac glycoside with a narrow therapeutic index. The possible interaction between NETU and Pgp has been assessed by analysing the effect of NETU on DIG pharmacokinetics. Safety parameters have also been assessed. Methods: This study was an open-label, fixed-sequence design to evaluate the effect of NETU on DIG at steady state in 16 healthy volunteers (8 male and 8 female). A loading dose of 3 x 0.5 mg DIG (0.5 mg every 6 hours) was given on day 1, followed by a daily oral dose of 0.25 mg DIG for 11 consecutive days (days 2-12); NETU was administered as single oral dose of 450mg on day 8. Serial blood and urine samples were collected for the determination of the pharmacokinetic parameters. Physical examination, vital signs, electrocardiogram (ECG), adverse events, clinical chemistry, hematology, urinalysis, and overall tolerability were reported. Results: Based on the AUC(0-24h) parameter at steady-state, the extent of DIG exposure was not influenced by NETU coadministration. The confidence interval of Cmin was within the 80-125% equivalence limits, while the observed Cmax was slightly over 125%, which was not considered clinically relevant. The excretion of DIG in urine was 57% after NETU coadministration compared to 55% of DIG alone. There were no gender-specific differences in the extent of absorption (AUC) for DIG, and no safety-related influence of DIG or NETU was observed on safety and laboratory assessments, vital signs, or ECG parameters. Based on historical data NETU pharmacokinetics was not affected by DIG coadministration. Conclusions: No clinically relevant interactions occurred between NETU and DIG. The results of this study suggest that the coadministration of NETU with Pgp substrates may not require dose adjustments. Study treatments were well tolerated.

Regulating exposure of the lens of the eye to ionising radiations

The International Commission on Radiological Protection (ICRP) has reviewed recentepidemiological evidence suggesting that, for the lens of the eye, the threshold in absorbeddose for the induction of deleterious health effects is about 0.5 Gy. On this basis, theCommission recommends that for occupational exposure in planned exposure situations,the equivalent dose limit for the lens of the eye should be 20 mSv in a year, averaged overdefined periods of 5 yr, with exposure not exceeding 50 mSv in any single year. This papersummarises the data that have been taken into account by the ICRP and criticallyexamines whether the proposed downward revision of the dose limit is justified. Overall, itis concluded that the accumulating radiobiological and epidemiological evidence makesit more appropriate to treat cataract induction as a stochastic rather than adeterministic effect. Within this framework, it is illogical to have the same dose limit forthe lens of the eye as for the whole body irradiated uniformly. This could beaddressed either by removing the special dose limit for the lens of the eye, assigning itan appropriate tissue weighting factor and including it in the computation ofthe effective dose, or through a composite approach involving the use of a tissueweighting factor for effective dose computations together with a special limiton the equivalent dose to the lens of the eye to ensure that no individual wassubject to an unacceptably high risk of induction of clinically significant cataracts.

Cavity-enhanced optical frequency comb spectroscopy in the mid-infrared application to trace detection of hydrogen peroxide

We demonstrate the first cavity-enhanced optical frequency comb spectroscopy in the mid-infrared wavelength region and report the sensitive real-time trace detection of hydrogen peroxide in the presence of a large amount of water. The experimental apparatus is based on a mid-infrared optical parametric oscillator synchronously pumped by a high power Yb:fiber laser, a high finesse broadband cavity, and a fast-scanning Fourier transform spectrometer with autobalancing detection. The comb spectrum with a bandwidth of 200 nm centered around 3.75 {\mu}m is simultaneously coupled to the cavity and both degrees of freedom of the comb, i.e., the repetition rate and carrier envelope offset frequency, are locked to the cavity to ensure stable transmission. The autobalancing detection scheme reduces the intensity noise by a factor of 300, and a sensitivity of 5.4 {\times} 10^-9 cm^-1 Hz^-1/2 with a resolution of 800 MHz is achieved (corresponding to 6.9 {\times} 10^-11 cm^-1 Hz^-1/2 per spectral element for 6000 resolved elements). This yields a noise equivalent detection limit for hydrogen peroxide of 8 parts-per-billion (ppb); in the presence of 2.8% of water the detection limit is 130 ppb. Spectra of acetylene, methane and nitrous oxide at atmospheric pressure are also presented, and a line shape model is developed to simulate the experimental data.

Evaluations of Parallelism Testing Methods Using ROC Analysis

Parallelism is often a prerequisite in relative potency determination using bioassays. It involves testing the similarity between a pair of dose–response curves of reference standard and the test sample. Parallelism testing methods currently in use include p-value-based significance tests and interval-based equivalence tests. Recently the conceptual and empirical properties of these tests have been assessed and compared by researchers. However, the evaluations are incomplete due to the lack of a common framework for comparing the two methods. Based on receiver operating characteristic (ROC) curve analysis, we propose that the area under the ROC curve (AUC) be used as an overall figure of merit for parallelism tests. A simulation study is conducted to compare the performance of significance and equivalence tests. We demonstrate that the equivalence test outperforms the significance test if the equivalence limits are properly selected. A method for determining the optimal equivalence limits is suggested. Such optimal equivalence limits potentially make the application of the equivalence test to parallelism testing both practical and feasible.

Tactile Sensibility of Single‐Tooth Implants and Natural Teeth Under Local Anesthesia of the Natural Antagonistic Teeth

The term osseoperception describes the capability of developing a subtle tactile sensibility over dental implants. The present clinical study aims at clarifying the question of how far tactile sensibility is to be attributed to the periodontium of the natural opposing tooth of the implant. Thirty-two subjects with single-tooth implants with natural opposing teeth were included in this clinical, single-blind, split-mouth study. The natural antagonistic tooth of the implant and the corresponding natural contralateral tooth were anesthetized with a locally infiltrated articaine anesthetic. In a computer-assisted and randomized way, copper foils of varying thickness (0-100 µm) were placed interocclusally between the single-tooth implant and the natural opposing tooth, and between the contralateral pair of natural opposing teeth in order to investigate the active tactile sensibility according to the psychophysical method of constant stimuli and evaluate it statistically by the Weibull distribution. The average tactile sensibility of the implants with anesthetized antagonists at the 50% value calculated by means of the Weibull distribution was 20 ± 11 µm with a support area (90%-10% value) of 77 ± 89 µm. For the pair of natural teeth, the tactile sensibility at the 50% value was 16 ± 9 µm with a support area of 48.4 ± 93 µm. This resulted in an average intraindividual difference of 3.5 ± 7 µm at the 50% value and 29 ± 93 µm in the support area. The statistical calculations demonstrated an equivalent tactile sensibility (50% value) of the single-tooth implant and the contralateral natural control tooth with the natural antagonists being anesthetized in each case (double t-test, equivalence limit ± 8 µm, P < 0.01, power >80%). Apparently, the active tactile sensibility of single-tooth implants with natural opposing teeth is not only to be attributed to the periodontium of the opposing tooth but also to a perception over the implant itself. This could support the hypothesis according to which the implant may have a tactile sensibility of its own.

The Impact of Endoscopic Retrograde Cholangiopancreatography Education on Radiation Exposure to Experienced Endoscopist: “Trainee Effect”

Endoscopic retrograde cholangiopancreatography(ERCP), as with other fluoroscopic procedures, carries the risk of exposure of staff to radiation. However, over the last two decades, only a few studies have investigated this risk. The aim of this work was to evaluate the dose of radiation exposure to staff participating in ERCP procedures in a busy teaching hospital that performs more than 1,850 procedures annually. The entire ERCP staff consisted of the experienced endoscopist, the assistant, and two nurses who were responsible for monitoring patients as well as keeping their heads in position during the procedure. RAD DOSE NEB.226 dosimeters, which were provided by the Turkish Atomic Energy Authority, were used for this study. Data on 110 consecutive therapeutic ERCP procedures was recorded. The mean fluoroscopy time was 5.65 ± 4.71 min. The mean fluoroscopy time of the 61 procedures performed by an experienced endoscopist alone was 5.41 ± 4.65 min, whereas the mean fluoroscopy time for the 49 procedures during which an assistant was involved was 5.94 ± 4.81 min (p = 0.56). In terms of median dose of ionizing radiation exposure to the eyes, the dose measurement per procedure in which the primary endoscopist participated alone was 72 microsievert (μSv), compared to 92 μSv when an assistant took part in theproceedings. Considering that the recommended annual equivalent dose limit to the lens of the eye is 150 mSv, by performing 1,850 procedures annually, the primary endoscopist exceeds this limit. Based on our results, taking into consideration the heavy workload in our hospital, it would seem that more experienced endoscopists are required to help provide training in ERCP, and that the use of lead acrylic goggles is required to decrease radiation exposure to the eyes.

Increasing Operational Stability in Low NOX GT Combustor Using Fuel Rich Concentric Pilot Combustor

Lean combustion is a method in which combustion takes place under low equivalence ratio and relatively low combustion temperatures. As such, it has the potential to lower the effect of the relatively high activation energy nitrogen-oxygen reactions which are responsible for substantial NOX formation during combustion processes. However, lowering temperature reduces the reaction rate and deteriorates combustion stability. The objective of the present study is to reduce the lower equivalence ratio limit of the stable combustion operational boundary in lean Gas Turbine (GT) combustors while still maintaining combustion stability.

Trace gas detection of molecular hydrogen H2 by photoacoustic stimulated Raman spectroscopy (PARS)

Photoacoustic stimulated Raman spectroscopy (PARS) has been used for sensitive and selective trace gas detection of molecular hydrogen under ambient conditions. In one experiment, 532 nm output of a seeded pulsed Nd:YAG laser is employed as Raman pump source and a Raman shifter filled with gaseous H(2) to obtain Stokes shifted radiation at 683 nm, suitable to stimulate H(2) Raman detection in a photoacoustic cell. A noise equivalent detection limit of 40 ppm by volume H(2) in 1 atm N(2) is obtained (14 mJ at 532 nm, 18 mJ at 683 nm, 10 Hz repetition rate, 58 s measurement time). Another experiment employs a dye laser for stimulating Raman radiation between 681-684 nm, allowing tuneable PARS. A Gaussian spectral fitting procedure has been applied giving a noise equivalent detection limit of 4.6 ppm by volume H(2) in 1 atm N(2) (35 mJ pulse energy at 532 nm, 45 mJ at 681-684 nm, 10 Hz repetition rate, 256 s measurement time). Spectroscopic detection offers the advantage of high selectivity along with the ability to obtain temperature and dynamic information from the rotational population and a line shape analysis, and also allows the discrimination between ortho- and para-H(2).

Cavity-enhanced Raman spectroscopy with optical feedback cw diode lasers for gas phase analysis and spectroscopy

A variant of cavity-enhanced Raman spectroscopy (CERS) is introduced, in which diode laser radiation at 635 nm is coupled into an external linear optical cavity composed of two highly reflective mirrors. Using optical feedback stabilisation, build-up of circulating laser power by 3 orders of magnitude occurs. Strong Raman signals are collected in forward scattering geometry. Gas phase CERS spectra of H(2), air, CH(4) and benzene are recorded to demonstrate the potential for analytical applications and fundamental molecular studies. Noise equivalent limits of detection in the ppm by volume range (1 bar sample) can be achieved with excellent linearity with a 10 mW excitation laser, with sensitivity increasing with laser power and integration time. The apparatus can be operated with battery powered components and can thus be very compact and portable. Possible applications include safety monitoring of hydrogen gas levels, isotope tracer studies (e.g., (14)N/(15)N ratios), observing isotopomers of hydrogen (e.g., radioactive tritium), and simultaneous multi-component gas analysis. CERS has the potential to become a standard method for sensitive gas phase Raman spectroscopy.

Bioequivalence Study of 1,500 mg Glucosamine Sulfate in Thai Healthy Volunteers

Glucosamine sulfate is widely used to relieve symptoms from osteoarthritis. This study was conducted in order to determine pharmacokinetic and assessed the in-vivo bioequivalence of two different hard capsule formulations of glucosamine sulfate when administered as equal dose of 1,500 mg. The two formulations contain different salt form where reference product is NaCl and test product is KCl. A randomized, single dose, two-treatment, two- period, two-sequence crossover study was conducted. Twenty-six healthy volunteers were recruited at Siriraj Clinical Research Unit. Each subject received a dose of 1,500 mg glucosamine sulfate of both formulations with at least a week washout period. Blood samples were collected over 24 hrs after the oral administration. The plasma fractions were analyzed for glucosamine using LC-MS/MS. Twenty-six volunteers enrolled in the present study. Pharmacokinetic parameters were determined using the non-compartment model. The 90% confidence intervals of the mean ratios (test/reference) of Cmax (111.19%; ranged from 93.01%-132.92%) and AUC0-t (107.24; ranged from 87.16%-131.93%) was not contained within the equivalence criteria of 80.00-125.00% (USFDA, 2003). However, this study showed the high intra-individual CV calculated from ANOVA for Cmax and AUC0-24 (≥ 30%). Thus, based on equivalence limits of USFDA (2003), the test product is not bioequivalent to the reference product in terms of rate and extent of absorption. However, concerning the wider equivalence criteria for highly variable drug (EMEA, 2008), the test product is bioequivalent to the reference formulation in terms of rate and extent of absorption.

Les limites de l’équivalence dans la traduction juridique

The limits of equivalence in legal translation &#x0D; It is obvious that the main specificity of legal texts is to refer to legal systems and forms of thought rooted in a culture specific to a particular country. The texts of law are the result of reflections of an ethical, philosophical, psychological, cultural and religious order and for this each concept has its own legal system which is based on founding texts such as the constitution for French and American law and the Koran. and the Sunna for the law of Muslim countries. Consequently, the translator will have to translate into the target language concepts and notions that often only exist in the source language. The present paper aims at shedding light on the processes adopted by translators when dealing with the translation of legal texts with its different domains. The translator presents the synthesis of the linguistic expression, of the law, that is to say a "jurilinguistics" at the confluence of the law and the language, because it is difficult to translate a legal document without knowing the law of the two languages as it is difficult for a lawyer to translate their text well without a perfect mastery and general knowledge of both languages.

RADIOLOGICAL IMPACT OF USING NIGERIAN DOLERITE (DIABASE) AS A CON- STRUCTION MATERIAL

The radiological impact of using natural dolerite as a construction material in Nigeria has been investigated by determining the natural radioactivity in dolerite samples collected from South West Nigeria. Gamma spectrometric measurements were carried out using a well -calibrated highly effi- cient Sodium doped with Iodide detector NaI (TL). Results show that the mean specific activities of 226Ra, 228Ra and 40K contained in this mineral varied from 50.5 – 52.0, 51.9 – 52.3 and 463.1 – 467.0 Bqkg-1 respectively. An external hazard index of 0.4 and a mean annual effective dose equivalent of 0.1 mSvy-1 were obtained. Since the hazard index is less than unity and the deter- mined dose equivalent below the internationally recommended dose equivalent limit of 1mSvy-1 for members of the public, it is concluded that Nigerian dolerite is a radiological friendly construc- tion (engineering) material.

Activity measurements of radon from construction materials

This work presents the results of radon concentration measurements of construction materials used in the Brazilian industry, such as clay (red) bricks and concrete blocks. The measurements focused on the detection of indoor radon activity during different construction stages and the analysis of radionuclides present in the construction materials. For this purpose, sealed chambers with internal dimensions of approximately 60×60×60cm3 were built within a protected and isolated laboratory environment, and stable air humidity and temperature levels were maintained. These chambers were also used for radon emanation reduction tests. The chambers were built in four major stages: (1) assembly of the walls using clay (red) bricks, concrete blocks, and mortar; (2) installation of plaster; (3) finishing of wall surface using lime; and (4) insulation of wall surface and finishing using paint. Radon measurements were performed using polycarbonate etched track detectors. By comparing the three layers applied to the masonry walls, it was concluded that only the last step (wall painting using acrylic varnish) reduced the radon emanation, by a factor of approximately 2. Samples of the construction materials (clay bricks and concrete blocks) were ground, homogenized, and subjected to gamma-ray spectrometry analysis to evaluate the activity concentrations of 226Ra, 232Th and 40K. The values for the index of the activity concentration (I), radium equivalent activity (Raeq), and external hazard index (Hext) showed that these construction materials could be used without restrictions or concern about the equivalent dose limit (1mSv/year).

Guidelines to establish relative potency are not in touch with reality

Garcia-Arieta [1] interprets our data [2] purely from a regulatory perspective with regard to demonstrating equivalence. In this regard, we demonstrated a significant overall dose–response relation from regression analysis of the common slope for shift in methacholine PC20, indicating assay sensitivity for this outcome. However, when one inspects the difference in PC20 shift between the 200 and 800 µg doses, while there was significant dose separation it has to be taken in the context of the biological variability which is of the order of ±1 doubling dilution (i.e. ±2-fold shift). Thus, one needs to distinguish between a statistically significant difference from what may be clinically irrelevant. Pointedly, our patients were selected a priori for being methacholine responsive, with a mean PC20 of 0.66 mg/ml−1, i.e. they had plenty of room for improvement in response to inhaled corticosteroid. When comparing the formulations at each dose level, the confidence limits for the mean difference in PC20 was contained within accepted limits of variability of ±1 doubling dilution, indicating therapeutic equivalence. Our study shows that even using n = 89 patients, while the point estimate for relative potency was close to unity, the 95% confidence interval was well outside of accepted pharmacodynamic equivalence limits. Given that this was performed within a single centre with considerable experience of challenge studies, we are of the firm opinion that it is not feasible to assess relative potency using Finney, and as such this should no longer be recommended in current guidelines for establishing equivalence. Although we also showed significant dose separation for suppression of exhaled nitric oxide, the mean difference between 200 and 800 µg was rather small, amounting to 14% with HFA and 11% with CFC, in comparison to 29 and 20% differences, respectively, for methacholine PC20 shift. We evaluated pharmacokinetic outcomes at steady state to mirror what happens in real-life clinical practice, where patients take their inhaled steroid twice daily and not as single doses, i.e. also to reflect the chronic dosing protocol for our challenge study. In fact, our data for area under the curve showed that the two formulations were equivalent within conventional limits of ±20%, in keeping with the challenge data when comparing the methacholine PC20 shift at each dose. Finally, subtle differences in pharmacokinetic and pharmacodynamic outcomes pointed out by Garcia-Arieta [1] need to be put in their true perspective, because variations in real-life inhaler technique will result in at least 50% differences in dose delivered to the lungs, even within the same individual from day to day. Thus, from a clinical perspective, a 10% difference in delivered dose is rather meaningless for the patient. In the light of our study, we believe that the guidelines are no longer in touch with the reality of performing clinical trials using surrogate inflammatory end-points with inhaled steroids and especially the need to calculate relative potency ratios using Finney.

Calculation of D-Section Classical V-Belt Power Rating in Different Reliability

The deficiencies of the Classical V-belt power rating calculation method in GB / T 11355 and GB / T 13575 is pointed. A new formula modifying the power rating with reliability factor is introduced. The data resulting from the step stress accelerated life testing of D-section Classical V-belt is transformed into equivalent limit stress data which is normal distribution, and then the limit stress of D-section Classical V-belt in different reliability and the corresponding reliability factor are determined, a calculating example by the new method is provided.

Assessing unintended effects of GM plants on biological species

A model for assessing the unintended environmental risks of GM plants to other biological species is outlined. The model starts by allowing the local values and concerns in a country to frame the identification of endpoint entities and endpoints. It classifies biological diversity into ecological functional groups that are directly associated with the values and concerns. Multi-criteria decision analysis is used to identify the highest priority endpoint entities for further evaluation. For each of these entities, risk hypotheses are identified and prioritized to specify assessment endpoints. This is illustrated with Bt cotton in Vietnam, with particular reference to potential harms if Bt cotton adversely affected a natural enemy species. The possible harm can be evaluated using an equivalence test. A method for establishing equivalence limits for generalist natural enemies is described using pest management theory. These limits are likely to be large, which implies that large changes in natural enemy populations are necessary to cause significant harm, and that sample sizes may be quite manageable to evaluate equivalence statistically. The model emphasizes clear, expert-driven, ecologically based decision-making and provides formal methods for conducting an environmental risk assessment.

O-vacancies in transition metal (TM) oxides: Coordination and local site symmetry of transition and negative ion states in TM 2O 3 and TMO 2 oxides

Removal of neutral O-atoms from a transition metal (TM) oxide results in two electrons residing within the vacated site. Two-electron multiplet theory has been used to develop a d 2 equivalent model. When applied to tetragonal HfO 2, the two electrons of neutral vacancy in the d 2 equivalent limit reside on two Hf d-state orbitals in a high-spin configuration. Transition energies and negative ion state features are detected in transition metal (TM) oxides by X-ray absorption spectroscopy (XAS) in the O K pre-edge/sub-band gap energy regime, and are compared with the model. These transitions are from the O 1s 2 doubly occupied core level approximately 543 eV below vacuum, and terminate in empty virtual bound states. In addition these strong spin-allowed transitions, spectra include weaker features corresponding to either spin-forbidden transitions in the d 2 model, or alternatively to a near-degeneracy with a singlet ground state with weak Hf-atom pair bonds. The analysis of O K edge XAS spectra identify a significant distinction between multiplet (i) triplet transition energies for neutral O-vacancies that are not active as electron or hole traps, (ii) O-vacancy negative ion states that are active as electron traps in Poole–Frenkel conduction or trap-assisted tunneling (TAT), and (iii) O-vacancy occupied ground states that can trap holes.

Micro-mobile Foot Compression Device Compared with Pneumatic Compression Device

A combination mechanical-pharmacologic regimen is an accepted prophylactic treatment against symptomatic venous thromboembolism for patients undergoing total hip and knee arthroplasties. Foot pumps have been recognized as effective mechanical devices. Research suggests pharmacologic prophylaxis for venous thromboembolism is associated with complications and foot pumps offer an adjunct or alternative approach. Presumably the effectiveness of foot pumps relate to enhancement of venous flow. We compared an established foot pump system with a new mobile foot pump for their ability to influence mean peak venous velocity in the common femoral, popliteal, and posterior tibial veins. We evaluated 60 healthy subjects with the established and the novel foot-pump systems. Ultrasonography was used to measure baseline and peak venous velocity with mechanical compression. We constructed 95% confidence intervals (CI) on the mean differences between the two devices to establish equivalence limits. We compared ratios of peak velocity to resting velocity. Subjects subjectively rated the two foot pumps with respect to size, fit, and comfort. The 95% CI test for equivalence of the mean differences between the two devices was inconclusive. The novel device augmented the venous velocity 11 times greater than the resting velocity in the posterior tibial vein and three times greater than the resting velocity in the popliteal vein. The established foot pump augmented the venous velocity 15 times greater than the resting velocity in the posterior tibial vein and four times greater than the resting velocity in the popliteal vein. The novel device rated better for size, fit, and comfort when compared with the established device. The established foot pump tended to be associated with greater peak velocities; the novel device produced more consistent mean peak venous velocities and may be more acceptable to patients and caregivers.

Evaluation of four commercial biuret reagent kits of serum total protein by the American Association for Clinical Chemistry reference measurement procedure

In China, the traceability of clinical chemistry methods is still immature. Therefore, it is necessary to establish a reference measurement procedure and evaluate commercial reagent kits using such established procedures. We reproduced the reference measurement procedure for serum total protein, as recommended by the American Association for Clinical Chemistry (AACC). We evaluated the performance by Clinical Laboratory Standard Institute (CLSI) guidelines EP15-A and EP6-A. Subsequently, four commercial reagent kits were evaluated by the reproduced reference procedure following CLSI guideline EP9-A2. The performance of the reproduced reference procedure was as follows: CVs ranged from 0.47% to 0.85% at medical decision levels (X(c)) of 45 g/L, 60 g/L and 80 g/L. Linearity was Y=1.0022X-0.2121 (r=0.9999), and recovery ranged from 100.2% to 102.4%. The External Quality Assessment Scheme for Reference Laboratories in Laboratory Medicine (RELA) was applied, and the result was within the limit of equivalence. The linear relationships of four commercial reagent kits, Merit Choice, KHB, Leadman, and Olympus, were, respectively: Y=0.9922X+0.5776 (r=0.9961); Y=0.9936X+0.4316 (r=0.9992); Y=0.9949X+0.9129 (r=0.9987) and Y=0.9923X+0.8876 (r=0.9989). KHB showed slight negative bias, and the mean±SD was -0.03±0.60 g/L. Merit Choice, Leadman, and Olympus all showed positive bias, and the mean±SDs were 0.02±0.63 g/L, 0.55±0.77 g/L and 0.34±0.71 g/L, respectively. The correlation and bias of four commercial reagent kits for serum total protein were found to be acceptable. Thus, these reagent kits can be used reliably in China.

Options for Controlling Localized Skin Dose

In this study, issue on the skin dose averaging area was reviewed with the results of calculated dose distribution from various beta emitters. In case of dot-like contamination such as a hot particle, according to calculated results, over 99 % of the dose was deposited within 1 mm radius. This result showed that the use of 10 cm 2 as the dose averaging area, recommended by the National Council on Radiation Protection and Measurement (NCRP), compromises the concept of dosimetry by intentionally including unexposed tissue volume to reduce the dose. Beside the approach recommended by NCRP, two other options were suggested and discussed. One option addressing a graded enforcement of the skin dose limit, considering the low probability of hot particle exposure, was proposed to avoid compromising the dosimetry concept. Though this option can give flexibility in the regulation of skin exposure, this option compromises the unified meaning of the dose limits. The other option addressed increase of the skin equivalent dose limit specifically for prevention of deterministic effects while applying a smaller averaging area for controlling stochastic effects. The first two options involve decision of the national or regional regulatory authority and the third involves actions at the International Commission on Radiological Protection (ICRP) level.