Closed-Loop Reflex Responses of the Lateral Ankle Musculature From Various Thresholds During a Lateral Ankle Sprain Perturbation.

CONTEXT: Latency is a reliable temporal metric used to evaluate sensorimotor integration of the fibularis longus (FL) and fibularis brevis (FB) during lateral ankle sprain perturbations. Currently, no clinical recommendations exist to select appropriate thresholds to evaluate the closed-loop reflex response of the lateral ankle musculature. The purpose of this study was to assess threshold value on latency of the FL and FB during an unanticipated inversion perturbation that simulates the mechanism of a lateral ankle sprain. DESIGN: Descriptive laboratory study. METHODS: Twenty healthy adults with no history of lateral ankle sprain injury completed an unanticipated single-leg drop landing onto a 25° laterally inclined force platform from a height of 30 cm. Surface electromyography recorded muscle activity data from the FL and FB during the inversion perturbation. Latency was identified at points where muscle activity exceeded 2, 5, and 10 SD above the average muscle activity 200 milliseconds prior to foot contact, and compared across threshold value using a 1-way analysis of variance (P < .05). RESULTS: The 2 SD threshold was significantly shorter than both 5 SD and 10 SD thresholds for the FL (P < .01) and FB (P < .01). Likewise, the 5 SD threshold was significantly shorter than the 10 SD thresholds for FL (P = .004) and FB (P = .003). CONCLUSIONS: More sensitive thresholds results in a shorter closed-loop reflexive response compared to the more rigorous thresholds. We recommend that selection of the appropriate threshold to identify latency of the lateral ankle musculature should be based on the device used to simulate a lateral ankle sprain and the ankle inversion velocity produced during the ankle inversion perturbation.

Report on the seventh meeting of national control laboratories for vaccines and biologicals of the WHO Western Pacific and South-East Asia member states.

The Biregional Network of National Control Laboratories (NCLs) of the WHO Western Pacific and South-East Asia Regions has been meeting annually since 2018 to enhance NCLs' voluntary participation capacity. Its seventh meeting was hosted by the Korea National Institute of Food and Drug Safety Evaluation (NIFDS) of the Ministry of Food and Drug Safety (MFDS), in conjunction with the Global Bio Conference, in Seoul on September 6, 2022. Over 60 participants from seven countries, (India, Indonesia, Japan, Korea, Malaysia, the Philippines, and Vietnam) attended the meeting on-site and online. The theme of this meeting was 'Quality Control Issues and International Trends for Biologicals including Vaccines and Plasma-Derived Medicinal Products.' Three special speeches were presented on sharing the quality control system for biologicals, including NCLs' considerations in preparing the WHO Listed Authorities and sharing MFDS experiences. Furthermore, the participating NCLs shared country-specific issues related to national lot releases during the COVID-19 pandemic and acknowledged the meeting's crucial role in response preparedness for pandemic emergencies and enhancing regulatory capacity through coalitions and information exchange among NCLs. The NIFDS will cooperate closely with other Asian NCLs to enhance biological product quality control, aiming to establish regional standards and standardize test methods through collaboration.

Wild-type p53 suppresses formin-binding protein-17 (FBP17) to reduce invasion.

Invading tumor cells develop membrane protruding structures called invadopodia to invade and metastasize. Previously, we have reported the role of formin-binding protein-17 (FBP17) in extracellular matrix degradation and invadopodia formation in breast cancer cells. Here, we report a novel axis between tumor-suppressor p53 and FBP17. We observed that cell lines with mutant p53 express FBP17 to a higher level. The expression of FBP17 was reduced upon stabilizing wild-type p53. Furthermore, the immunohistochemistry analysis of breast cancer tissue microarrays demonstrated the correlation between the accumulation of p53 and enhanced FBP17 staining in invasive ductal carcinomas. The double knockdown of p53 and FBP17 showed the contribution of FBP17 in the invasion of cancer cells where p53 lost the regulatory control over FBP17. Taken together, these studies indicate that FBP17 may be a marker to understand the invasion propensity of breast cancer.

Prognostic significance of CHAC1 expression in breast cancer.

BACKGROUND: An emerging component of Unfolded Protein Response (UPR) pathway, cation transport regulator homolog 1 (CHAC1) has been conferred with the ability to degrade intracellular glutathione and induce apoptosis, however, many reports have suggested a role of CHAC1 in cancer progression. Our study aimed to investigate CHAC1 mRNA levels in large breast cancer datasets using online tools and both mRNA and protein levels in different breast cancer cell lines. METHODS AND RESULTS: Analysis of clinical information from various online tools (UALCAN, GEPIA2, TIMER2, GENT2, UCSCXena, bcGenExMiner 4.8, Km Plotter, and Enrichr) was done to elucidate the CHAC1 mRNA expression in large breast cancer patient dataset and its correlation with disease progression. Later, in vitro techniques were employed to explore the mRNA and protein expression of CHAC1 in breast cancer cell lines. Evidence from bioinformatics analysis as well as in vitro studies indicated a high overall expression of CHAC1 in breast tumor samples and had a significant impact on the prognosis and survival of patients. Enhanced CHAC1 levels in the aggressive breast tumor subtypes such as Human Epidermal growth factor receptor 2 (HER2) and Triple Negative Breast Cancer (TNBC) were evident. Our findings hint toward the possible role of CHAC1 in facilitating the aggressiveness of breast cancer and the disease outcome. CONCLUSION: In summary, CHAC1 is constantly up-regulated in breast cancer leading to a poor prognosis. CHAC1, therefore, could be a promising candidate in the analysis of breast cancer diagnosis and prognosis.

Biomedical applications of L-alanine produced by Pediococcus acidilactici BD16 (alaD+).

L-alanine possesses extensive physiological functionality and tremendous pharmacological significance, therefore could be considered as potential ingredient for food, pharmaceutical, and personal care products. However, therapeutic properties of L-alanine still need to be addressed in detail to further strengthen its utilization as a viable ingredient for developing natural therapeutics with minimum side effects. Thus, the present study was aimed to explore the anticipated therapeutic potential of L-alanine, produced microbially using a lactic acid bacterial strain Pediococcus acidilactici BD16 (alaD+) expressing L-alanine dehydrogenase enzyme. The anticipated therapeutic potential of L-alanine was assessed in terms of anti-proliferative, anti-bacterial, and anti-urolithiatic properties. Anti-bacterial assays revealed that L-alanine successfully inhibited growth and in vitro proliferation of important human pathogens including Enterococcus faecalis, Escherichia coli, Klebsiella pneumonia, Staphylococcus aureus, Streptococcus mutans, and Vibrio cholerae in a concentration-dependent manner. Current investigation has also revealed its significant anti-proliferative potential against human lung adenocarcinoma (A549; IC50 7.32 µM) and mammary gland adenocarcinoma (MCF-7; IC50 8.81 µM) cells. The anti-urolithiatic potential of L-alanine was augmented over three different phases, viz., nucleation inhibition, aggregation inhibition, and oxalate depletion. Further, an in vitro cell culture-based kidney stone dissolution model using HEK293-T cells was also established to further strengthen its anti-urolithiatic potential. This is probably the first in vitro cell culture-based model which experimentally validates the immense therapeutic efficacy of L-alanine in treating urolithiasis disease. KEY POINTS: • Assessment of therapeutic potential of L-alanine produced by LAB. • L-alanine exhibited significant anti-proliferative and anti-bacterial activities. • L-alanine as potential anti-urolithiatic agent.

Comparison of the Capacitance of a Cyclically Fatigued Stretch Sensor to a Non-Fatigued Stretch Sensor When Performing Static and Dynamic Foot-Ankle Motions.

Motion capture is the current gold standard for assessing movement of the human body, but laboratory settings do not always mimic the natural terrains and movements encountered by humans. To overcome such limitations, a smart sock that is equipped with stretch sensors is being developed to record movement data outside of the laboratory. For the smart sock stretch sensors to provide valuable feedback, the sensors should have durability of both materials and signal. To test the durability of the stretch sensors, the sensors were exposed to high-cycle fatigue testing with simultaneous capture of the capacitance. Following randomization, either the fatigued sensor or an unfatigued sensor was placed in the plantarflexion position on the smart sock, and participants were asked to complete the following static movements: dorsiflexion, inversion, eversion, and plantarflexion. Participants were then asked to complete gait trials. The sensor was then exchanged for either an unfatigued or fatigued plantarflexion sensor, depending upon which sensor the trials began with, and each trial was repeated by the participant using the opposite sensor. Results of the tests show that for both the static and dynamic movements, the capacitive output of the fatigued sensor was consistently higher than that of the unfatigued sensor suggesting that an upwards drift of the capacitance was occurring in the fatigued sensors. More research is needed to determine whether stretch sensors should be pre-stretched prior to data collection, and to also determine whether the drift stabilizes once the cyclic softening of the materials comprising the sensor has stabilized.

Mechanisms of Anti-Tumor Activity of Withania somnifera (Ashwagandha).

Increasing herbal formulations have been used to treat several diseases including cancer. W. somnifera (Ashwagandha) is one such plant the extracts of which have been tested against a number of ailments including cancer, which remains as one of the most dreadful diseases on the globe. The ever-increasing number of cancer related mortality demands the development of novel chemopreventive agents with minimum side effects. Different compounds isolated from various parts of the plant like root, stem, and leaves have been reported to display significant anti-cancerous and immunomodulating properties and thus can be used alone or in combination with other chemotherapeutic drugs for cancer treatment. Through this review, we highlight the importance of W. somnifera in countering the potential oncogenic signaling mediators that are modulated by active constituents of W. somnifera in a variety of cancer types. Further, we hope that active constituents of W. somnifera will be tested in clinical trials so that they can be used as an important adjuvant in the near future for the effective treatment of cancer.

External Load and Muscle Activation Monitoring of NCAA Division I Basketball Team Using Smart Compression Shorts.

There is scarce research into the use of Strive Sense3 smart compression shorts to measure external load with accelerometry and muscle load (i.e., muscle activations) with surface electromyography in basketball. Sixteen external load and muscle load variables were measured from 15 National Collegiate Athletic Association Division I men's basketball players with 1137 session records. The data were analyzed for player positions of Centers (n = 4), Forwards (n = 4), and Guards (n = 7). Nonparametric bootstrapping was used to find significant differences between training and game sessions. Significant differences were found in all variables except Number of Jumps and all muscle load variables for Guards, and all variables except Muscle Load for Forwards. For Centers, the Average Speed, Average Max Speed, and Total Hamstring, Glute, Left, and Right Muscle variables were significantly different (p < 0.05). Principal component analysis was conducted on the external load variables. Most of the variance was explained within two principal components (70.4% in the worst case). Variable loadings of principal components for each position were similar during training but differed during games, especially for the Forward position. Measuring muscle activation provides additional information in which the demands of each playing position can be differentiated during training and competition.

Impact of Fat Grip Attachments on Muscular Strength and Neuromuscular Activation During Resistance Exercise.

ABSTRACT: Krings, BM, Shepherd, BD, Swain, JC, Turner, AJ, Chander, H, Waldman, HS, McAllister, MJ, Knight, AC, and Smith, JW. Impact of fat grip attachments on muscular strength and neuromuscular activation during resistance exercise. J Strength Cond Res 35(2S): S152-S157, 2021-The purpose of this study was to examine the acute effects of Fat Gripz (FG) on muscular activation and strength. Resistance trained men (n = 15; age = 22.4 ± 2.3 years; mass = 83.2 ± 11.1 kg) performed 2 experimental trials in a randomized order. Subjects completed 1 repetition maximum (1RM) testing with an Olympic barbell (OB) and with FG attached to an OB during the exercises of deadlift, bent-over row, upright row, concentration curl, and completed maximum repetitions of pull-ups until failure. Surface electromyography (EMG) was used to measure muscle activity from 8 upper extremity muscles (trapezius, medial deltoid, biceps brachii, triceps brachii, flexor carpi radialis, flexor carpi ulnaris, extensor carpi radialis, and extensor carpi ulnaris), while performing maximal voluntary isometric contractions during 1RM trials and while performing maximum number of pull-ups. When using the FG, 1RM strength was significantly decreased for each exercise, and the maximal number of pull-ups completed was significantly lower. Electromyography muscle activity was significantly increased in the forearm and shoulder muscles, but significantly decreased in the upper arm muscles with the use of FG during deadlift, bent-over row, and pull-ups. However, there were no differences for EMG activity for upright row and concentration curl. Differences in maximal strength, pull-up performance, and EMG activity with FG use may be due to the different muscle length positions. Although FG training may increase neuromuscular activation, decrements in muscular strength may result in prescribing low training loads that may not be ideal for building muscular strength.

Closing the Wearable Gap-Part V: Development of a Pressure-Sensitive Sock Utilizing Soft Sensors.

The purpose of this study was to evaluate the use of compressible soft robotic sensors (C-SRS) in determining plantar pressure to infer vertical and shear forces in wearable technology: A ground reaction pressure sock (GRPS). To assess pressure relationships between C-SRS, pressure cells on a BodiTrakTM Vector Plate, and KistlerTM Force Plates, thirteen volunteers performed three repetitions of three different movements: squats, shifting center-of-pressure right to left foot, and shifting toes to heels with C-SRS in both anterior-posterior (A/P) and medial-lateral (M/L) sensor orientations. Pearson correlation coefficient of C-SRS to BodiTrakTM Vector Plate resulted in an average R-value greater than 0.70 in 618/780 (79%) of sensor to cell comparisons. An average R-value greater than 0.90 was seen in C-SRS comparison to KistlerTM Force Plates during shifting right to left. An autoregressive integrated moving average (ARIMA) was conducted to identify and estimate future C-SRS data. No significant differences were seen in sensor orientation. Sensors in the A/P orientation reported a mean R2 value of 0.952 and 0.945 in the M/L sensor orientation, reducing the effectiveness to infer shear forces. Given the high R values, the use of C-SRSs to infer normal pressures appears to make the development of the GRPS feasible.

Closing the Wearable Gap-Part II: Sensor Orientation and Placement for Foot and Ankle Joint Kinematic Measurements.

The linearity of soft robotic sensors (SRS) was recently validated for movement angle assessment using a rigid body structure that accurately depicted critical movements of the foot-ankle complex. The purpose of this study was to continue the validation of SRS for joint angle movement capture on 10 participants (five male and five female) performing ankle movements in a non-weight bearing, high-seated, sitting position. The four basic ankle movements-plantar flexion (PF), dorsiflexion (DF), inversion (INV), and eversion (EVR)-were assessed individually in order to select good placement and orientation configurations (POCs) for four SRS positioned to capture each movement type. PF, INV, and EVR each had three POCs identified based on bony landmarks of the foot and ankle while the DF location was only tested for one POC. Each participant wore a specialized compression sock where the SRS could be consistently tested from all POCs for each participant. The movement data collected from each sensor was then compared against 3D motion capture data. R-squared and root-mean-squared error averages were used to assess relative and absolute measures of fit to motion capture output. Participant robustness, opposing movements, and gender were also used to identify good SRS POC placement for foot-ankle movement capture.

Impact of military type footwear and load carrying workload on postural stability.

Postural stability has been shown to be impacted by footwear and task performed. This study analysed the impact of two military footwear, standard boot (STB) and minimalist boot (MTB) on postural stability, before (PRE) and after (POST) a load carriage task. Sixteen participants were tested for postural stability using sensory organisation and motor control tests on Neurocom Equitest™. Postural sway, equilibrium scores and postural latencies were analysed using a two-factor repeated measures ANOVA: boot type (STB-MTB) × time (PRE-POST) load carriage task. Significantly greater postural sway variables, lower balance scores and slower postural latencies were seen in STB and POST load carriage conditions (p < .05). The results suggest that MTB exhibited greater balance compared to STB in balance conditions that rely on somatosensory feedback and that balance is lowered after a load carriage task. Decrements in postural stability could be attributed to boot design characteristics and muscular exertion due to the load carriage task. Practitioner Summary: Maintaining optimal postural stability is crucial in military. Impact of military footwear types and load carriage task on postural stability are addressed. Findings provide footwear design and physical exertion implications on postural stability leading to potential interventions that reduce postural stability decrements; thereby, reducing potential falls and fall related injuries.

Lower-Extremity Kinematics During Ankle Inversion Perturbations: A Novel Experimental Protocol That Simulates an Unexpected Lateral Ankle Sprain Mechanism.

CONTEXT: Lateral ankle sprains are a common injury in which the mechanics of injury have been extensively studied. However, the anticipatory mechanisms to ankle inversion perturbations are not well understood. OBJECTIVE: To examine lower-extremity kinematics, including spatial and temporal variables of maximum inversion displacement and maximum inversion velocity, during landings on a tilted surface using a new experimental protocol to replicate a lateral ankle sprain. SETTING: Three-dimensional motion analysis laboratory. PARTICIPANTS: A total of 23 healthy adults. INTERVENTIONS: Participants completed unexpected (UE) and expected (EXP) unilateral landings onto a tilted surface rotated 25° in the frontal plane from a height of 30 cm. MAIN OUTCOME MEASURES: Ankle, knee, and hip kinematics at each discrete time point from 150 ms pre-initial contact (IC) to 150 ms post-IC, in addition to maximum ankle inversion and maximum inversion velocity, were compared between UE and EXP landings. RESULTS: The UE landing produced significantly greater maximum inversion displacement (P < .01) and maximum inversion velocity (P = .02) than the EXP landing. Significantly less ankle inversion and internal rotation were found during pre-IC, whereas during post-IC, significantly greater ankle inversion, ankle internal rotation, knee flexion, and knee abduction were observed for the UE landing (P < .05). In addition, significantly less hip flexion and hip adduction were observed for the UE landing during pre-IC and post-IC (P < .05). CONCLUSIONS: Differences in the UE and EXP landings indicate the experimental protocol presented a UE inversion perturbation that approximates the mechanism of a lateral ankle sprain. Furthermore, knowledge of the inversion perturbation elicited a hip-dominant strategy, which may be utilized to assist with ankle joint stabilization during landing to further protect the lateral ankle from injury.

Toca-1 is suppressed by p53 to limit breast cancer cell invasion and tumor metastasis.

INTRODUCTION: Transducer of Cdc42-dependent actin assembly-1 (Toca-1) recruits actin regulatory proteins to invadopodia, and promotes breast tumor metastasis. Since metastatic breast tumors frequently harbor mutations in the tumor suppressor p53, we tested whether p53 regulates Toca-1 expression. METHODS: Normal mammary epithelial cells (HBL-100, MCF10A) and breast cancer cell lines expressing wild-type (WT) p53 (DU4475, MTLn3) were treated with camptothecin or Nutlin-3 to stabilize p53 to test effects on Toca-1 mRNA and protein levels. Chromatin immunoprecipitation (ChIP) assays were performed to identify p53 binding site in Toca-1 gene. Stable silencing of p53 and Toca-1 were performed in MTLn3 cells to test effects on invadopodia and cell invasion in vitro, and tumor metastasis in vivo. RESULTS: We observed that breast cancer cell lines with mutant p53 have high levels of Toca-1 compared to those with WT p53. Stabilization of WT p53 led to further reduction in Toca-1 mRNA and protein levels in normal breast epithelial cells and breast cancer cells. ChIP assays revealed p53 binding within intron 2 of toca1, and reduced histone acetylation within its promoter region upon p53 upregulation or activation. Stable silencing of WT p53 in MTLn3 cells led to increased extracellular matrix degradation and cell invasion compared to control cells. Interestingly, the combined silencing of p53 and Toca-1 led to a partial rescue of these effects of p53 silencing in vitro and reduced lung metastases in mice. In human breast tumors, Toca-1 levels were high in subtypes with frequent p53 mutations, and high Toca-1 transcript levels correlated with increased risk of relapse. CONCLUSIONS: Based on these findings, we conclude that loss of p53 tumor suppressor function in breast cancers leads to upregulation of Toca-1, and results in enhanced risk of developing metastatic disease.

Effects of an Auditory Versus Visual Stimulus on Reaction and Response Time During Countermovement Jumps.

Reacting and responding to an external stimulus is an important component of human performance, and they inform us about a participant's neurophysiological capabilities. Our purpose in this study was to determine whether reaction times (REACT), response times (RT), and countermovement jump (CMJ) performance differ when responding to an auditory (AUD) versus visual (VIS) stimulus. Participants were 17 college-aged volunteers (6 females and 11 males; M age = 23.0, SD = 3.4 years; M height = 174.57, SD = 10.37 cm; M body mass = 73.37, SD = 13.48 kg). Participants performed CMJs on force plates immediately upon receiving an AUD or a VIS stimulus. The AUD stimulus was a beep noise, while the VIS stimulus was a light on a screen in front of the participants. We determined REACT for the tibialis anterior (TA), medial gastrocnemius (GM), vastus lateralis (VL), and biceps femoris (BF) muscles to be the amount of time between stimulus onset and the initiation of the muscle's electromyographic (EMG) signal. We determined RT to be the amount of time between stimulus onset and the beginning of the participant's force production. We assessed CMJ performance via ground reaction forces during the unweighting, braking, and propulsive phases of the jump. We quantified EMG amplitude and frequency during each CMJ phase. We found RT to be faster to the AUD versus the VIS stimulus (p = .007). VL and BF muscles had faster REACT than TA and GM muscles (p ≤ .007). The AUD stimulus was associated with faster CMJ unweighting phase metrics (p ≤ .005). Thus, individuals may react and respond faster to an AUD versus VIS stimulus, with limited improvements in their subsequent physical performance.

SARS-CoV-2 spike protein expression as an identification in quality control testing for Adenovector based COVID-19 vaccine.

AIM: Quality control testing of the vaccine for lot release is of paramount importance in public health. A recent pandemic caused by the SARS-CoV-2 virus brought together all spheres of vaccine to combat the virus. The scientific advancement in the development of vaccines facilitated the scientists to develop the vaccine against SARS-CoV-2 in a record time. Thus, these vaccines should be stringently monitored for their safety and efficacy as per the latest WHO and national regulatory guidelines, and quality control evaluation of the product should be done at national control laboratories before releasing the product into the market as it assures the quality and safety of the vaccine. METHODS: The SARS-CoV-2 exploited the ACE2 (Angiotensin Converting Enzyme 2) receptor, a surface protein on mammalian cells to gain entry into the host cells. The viral surface protein that interacted with the ACE2 receptor is the Spike protein of SARS-CoV-2. Thus, in the development of the vaccine and assessing its quality, the Spike protein of SARS-CoV-2 became an attractive immunodominant antigen. In National Institute of Biologicals, an apex body in the testing of biologicals in India, received the Adenovector (Adenovirus + vector) based COVID-19 vaccine, a finished product for quality evaluation. Due to the lack of a pharmacopeial monograph, the testing of the vaccine was done as per the manufacturer's specifications and methods. The routine assays of identification employed by the manufacturer do not reflect the expression of Spike protein which is required for the immune system to get activated. In this report, we showed the determination of Spike protein expression by immunoblotting and immunofluorescence for identification parameters in the quality testing of the COVID-19 vaccine. We determined the translation of the SARS-CoV-2 Spike gene cloned into an Adenovector. RESULTS: The results from these experiments indicated the expression of Spike protein upon infection of mammalian cells with viral particles suggested that the expression of immunodominant Spike protein of SARS-CoV-2 may be employed by quality control laboratories as a parameter for identification. CONCLUSION: The study suggested that the determination of the expression of Spike protein is pertinent to identifying the Adenovector based vaccines against COVID-19.

The Distribution Patterns of Rhesus (Rh) Antigens.

INTRODUCTION: The determination of one's blood group is dictated by the inheritance-based diversity in the presence or absence of RBC antigens on the surface. Extended Rhesus (Rh) antigens are the most clinically relevant antigens of blood group systems after the ABO blood group system in transfusion medicine. The aim of this study was to serologically assess the prevalence of extended Rh antigens across diverse blood group systems. METHODS: A total of 2043 samples were tested for the ABO blood group and Rh typing with monoclonal antisera. The Rh phenotyping (C, c, E, e ) was performed on all the samples. RESULTS: The most frequently observed ABO blood group was O (36.5%), while AB (13.6%) was identified as the least prevalent. Positive Rh D antigen was found in 91.6% of tested samples, while 8.4% were Rh D-negative. The most frequently encountered antigen was e, followed by D, while the least prevalent was E. DISCUSSION: Establishing a Rh phenotype repository for blood donors and conducting Rh phenotype assessments as part of pretransfusion testing before initiating the initial blood transfusion for each patient could significantly lower the patients' incidence of alloimmunization.

Less is more: Validating a single method for comprehensive rh-insulin analysis.

The objective of this current study is to establish a single method for potency and related proteins analysis of human insulin formulations using reverse-phase high performance liquid (RP-HPLC) chromatography technique which was validated and verified for the potency analysis in insulin formulations. Chromatographic separation was achieved using an octadecylsilane (C-18) stationary phase and a mobile phase composed of 55% (v/v) buffer (0.2 M sodium sulfate in water, {pH 2.3}) and 45% (v/v) acetonitrile. Detection was performed by UV detector at 214 nm with a flow rate of 1 ml/min and an injection volume of 20 µL, at 40°C. Currently there are separate methods available in Indian Pharmacopoeia for analysis of Potency and Related proteins in human insulin. We have validated a single method where quantitation of potency and related proteins can be performed in the same run. The method validation exhibited linearity over the concentration range of 0.08-4.5 mg/ml (r2=0.999) with limit of detection of 0.094 mg/ml The accuracy of the method was 99-102.8%. Thus, it is proposed that both potency and related proteins in insulin formulations can be precisely evaluated using a single run thus saving the time and cost for quality analysis of insulin preparations both at manufacturing and regulatory laboratories which in turn will increase the market availability of such standard quality insulin preparations for public health use.

An initial set of reference values for the Balance Tracking System (BTrackS) Limits of Stability protocol.

BACKGROUND: The Balance Tracking System (BTrackS) Limits of Stability (LOS) protocol is a relatively new means of evaluating unconstrained dynamic postural control ability. While the reliability of this protocol has previously been established, reference data is currently unavailable to assist in the interpretation of results. RESEARCH QUESTION: What are typical reference values for the BTrackS LOS protocol with respect to sex, height, and BMI? METHODS: A cross= -section of 800 healthy, young adults (aged 18-29 years; 368 men, 432 women) were administered the BTrackS LOS protocol. Sex, height and weight variables were also captured for the participants. RESULTS: Results of a stepwise linear regression showed that the outcome measure for BTrackS LOS testing (i.e. LOS Area) was larger in taller individuals and in men. Based on these findings, four percentile ranking categories were established and associated look-up tables created. SIGNIFICANCE: The reference values provided by this study offer much needed guidance to clinicians and researchers for the determination of dynamic balance abnormalities based on BTrackS LOS testing.