Bioavailability and Bioequivalence Study of Antiepileptic Drug in Healthy Human Volunteers

The study of a bioequivalence study is to demonstrate equivalence within the acceptance range regarded as clinically relevant. The primary concern in bioequivalence assessment is to limit the risk of erroneously accepting bioequivalence. Only statistical procedures, which do not exceed the nominal risk of 5%, can be approved, and among them the one with the smallest risk of erroneously rejecting bioequivalence should be selected. In case of a parametric approach the inclusion of the classical 90% confidence interval for the chosen measure of relative bioavailability within the acceptance range (bioequivalence range) is the procedure of choice. This procedure is equivalent to the rejection of two one sided hypotheses concerning bioinequivalence at the nominal 5%- level. According to present views concentrations and concentration-related characteristics (e.g. AUC, MRT) should preferably be tested after logarithmic transformation. If the assumption of a log normal (AUC, Cmax) distribution or normal (tmax) distribution in the parametric approach is doubtful, a corresponding non-parametric approach is recommended. This approach may also be chosen as the general statistical approach to evaluate all bioavailability characteristics throughout a given study. Assumptions on the design or statistical analysis should be discussed, the study procedures followed were in compliance with the protocol, the ICHGCP guidelines and Schedule Y. From the analyses of pharmacokinetic and statistical results it was inferred that, for the ln-transformed data, the 90 % confidence interval about the test to reference ratio of Cmax, AUC0-t and AUC0-∞ of drug Primidone were falling within the bioequivalence acceptance range of 85.00 % - 109.00 %, which demonstrates the bioequivalence of test formulation ‘T’ with reference formulation ‘R’ under fasting conditions. From the clinical data it can be concluded that the study objectives like the safety and efficacy of the test product has been achieved

Detection of Glaucoma and Microaneurysm in Retinal Fundus Images Based on Optic Disk and Optic Cup Segmentation

Diabetes cause’s metabolic and physiological abnormalities in the retina and the changes suggest a role for inflammation in the development of diabetic retinopathy. The occurrence of micro aneurysms, a small red dot in retinal layer in the eye, is one of the early signs of diabetic retinopathy. To serve this purpose, various automated systems have been designed which includespreprocessing methods and candidate extractors. The objectives of this paper are to classify different stages of diabetic retinopathy as mild, Moderate, and Severe. Glaucoma is an irreversible chronic eye disease that leads to vision loss. In this paper, we propose a method for cup to disc ratio (CDR) assessment using 2-D retinal fundus images. In the proposed method, the optic disc and optic cup is segmented using thresholding algorithm. The cup to disc ratio (CDR) is computed based on the measurement of the segmented optic disc and optic cup. The Cup to Disc Ratio (CDR) of the color retinal fundus camera image is the primary identifier to confirm Glaucoma for a given patient

A CASE REPORT ON WILSON’S DISEASE: A RARE CLINICAL CONDITION OF COPPER DEPOSITION IN LIVER

Wilson’s disease is a rare inherited disorder and is characterized by the accumulation of copper in various tissues and also in organs like the liver, brain, kidneys and cornea. Symptoms in paediatrics characteristically appear with hepatic involvement. In this case we have discussed about an eleven-year-old male child, who was presented to the Paediatric department in a tertiary care hospital with chief complaints of yellowish discoloration of eyes, dark coloured urine and high grade fever. Due to the accumulation of copper there were decreased levels of ceruloplasmin and there was an increased 24 hour urinary copper, which confirms the Wilson’s disease in this child. Child was treated with Cephalosporin antibiotics, vitamins, laxative, and bile acid sequestrants. Child showed gradual improvement in clinical symptoms and got discharged without any further event. Quality of evidence was assessed according to the GRADE system. Early diagnosis and management helped to prevent serious complications

A study on the clinical manifestations and the incidence of benign and malignant tumors in a solitary thyroid nodule

Tumors are either benign or malignant. The thyroid nodule, which is usually a clinical manifestation of most of the thyroid disorders, is one among them which has been the subject of controversies with divergent opinions and views. Clinical presentation of thyroid nodules varies widely ranging from solitary nodules to benign and malignant tumors. Thyroid nodules accounts up to 8% of the adult population having palpable nodules. However studies on its incidence in the population residing near seacoast are limited. Hence, the present study is carried in an aim to evaluate the clinico-pathological correlation of solitary thyroid nodule and the incidence of malignancy in the population residing at sea coast. The study is conducted in the Narayana Medical College & Hospital (NMCH), which is situated within 10-15 km radius of the seacoast in Nellore district of Andhra Pradesh, India. In this study, 73 subjects were selected who presented with thyroid swelling which was clinically confirmed as solitary thyroid nodule. Out of 73 cases, 12 cases (16.5%) were found to have malignant lesions with remaining 61 cases (83.5%) being benign lesions. The incidence of malignancy among solitary thyroid nodule subjects is up to 16.5% in the population residing near seacoast. Thus the present study warrants people to consult surgeons for early diagnosis and adequate treatment without being passive as most of these swellings are asymptomatic for long duration

MANAGEMENT OF STRESS RELATED PSORIASIS W. S. R. TO CHETAH SAMAVAYI

There is a wide range of importance for appearance in present era. Psoriasis is chronic disorder which is commonly encountered in day to days clinical practices. It is one of the burning issue having social importance. Increased stress and life style are main predisposing factor which is accounting for wide spared prevalence of this disease. Usually10-15% cases present before general practitioners are pertaining to skin diseases. Due to altered life style, lack of physical exercise, unhygienic, mental stress, over eating, skin diseases are commonly observed. We can observe many diseases popping up especially due to mental stress i.e., Manasa Vikriti. There is Samavaya Sambandha between Tvacha and Manas (Chetah Samavayi). Most of the Tvak Vikaras are psychologically agonising and have negative impact on quality of life. Here it is important to remember the citation of Acharya Charaka regarding the relationship between the Tvacha and Manas, Tvacha is considered as Chetah Samvayi i.e., the skin has an eternal relationship with Manas (psyche/mind). The knowledge of Nidana is helpful for the proper diagnosis, prevention of disease and treatment also. Thus to treat any Tvak Gata Vikara, Bhishak should consider the skin ailment as well as condition of Manas. This paper highlights a case study of stress related Kitibha Kusta (Psoriasis) treated with Shodhana Chikitsa.

Identification of Novel QTLs for BPH Tolerance in Rice Using Resistant Donor BM 71

Rice is the most widely grown crop in the world, feeding half of the world’s population. Brown plant hopper (BPH) is a considerable risk to rice fields carrying 20-90% yield losses. Hopper burn can be effectively managed by the recognition and use of BPH genes. Marker based genetic analysis of 136 RILcollected from a high yielding susceptible variety, MTU 3626 and BM 71, a BPH donor developed at RARS, identified 3 minor novel QTLs viz; qmbph2.1,qmbph4.1 and qmbph12.1 on chromosomes 2, 4 and 12 and two other QTLson chromosome 5 and 7, namelyqmbph5.1 and qmbph7.1. The phenotyping of RIL’s revealed that ten RIL’s (2711 – 31, 2711 – 37, 2711 – 50, 2711 – 69, 2711 – 84, 2711 – 88, 2711 – 94, 2711 – 100, 2711 – 168 and 2711 – 191) recorded yields comparable to checks, Swarna and Pushyami along with BPH score similar to donor. The BPH resistance lines recognised will be further evaluated, and the confirmed lines can be employed in rice breeding programs

Comparison of capillary based microflurometric assay for CD4+ T cell count estimation with dual platform Flow cytometry

The CD4+ T cell count estimation is an important monitoring tool for HIV disease progression and efficacy of anti-retroviral treatment (ART). Due to availability of ART at low cost in developing countries, quest for reliable cost effective alternative methods for CD4+ T cell count estimation has gained importance. A simple capillary-based microflurometric assay (EasyCD4 System, Guava Technology) was compared with the conventional flow cytometric assay for estimation of CD4+ T cell counts in 79 HIV infected individuals. CD4+ T cell count estimation by both the assays showed strong correlation (r = 0.938, p < 0.001, 95% CI 0.90 to 0.96). The Bland Altman plot analysis showed that the limits of variation were within agreeable limits of ± 2SD (-161 to 129 cells/mm(3)). The Easy CD4 assay showed 100% sensitivity for estimating the CD4+ T cell counts < 200 cells/mm(3 )and < 350 cells/mm(3 )and 97% sensitivity to estimate CD4+ T cell count < 500 cells/mm(3). The specificity ranged from 82 to 100%. The Kappa factor ranged from 0.735 for the CD4+ T cell counts < 350 cells/mm(3 )to 0.771 for < 500 cells/mm(3 )CD4+ T cell counts. The system works with a simple protocol, is easy to maintain and has low running cost. The system is compact and generates minimum amount of waste. Hence the EasyCD4 System could be applied for estimation of CD4+ T cell counts in resource poor settings

POTENTIAL OF BAJRA [PENNISETUM GLAUCUM (L.) R. BR.] IN HEALTH AND DISEASE

Bajra, also known as pearl millet, African millet or spiked millet, originated in Northern-Central Sahel of West Africa, was introduced 2500 years ago into Indian subcontinent. However, it is mentioned in Ayurvedic texts from 14th Century AD onwards as Nali under Truna dhanya or Kudhanya vargas. It is considered as a major source of Gluten free diet and is used in the management of Coeliac disease and other gluten allergy conditions worldwide. Indians are also including millet into their day to day diet in accordance with the global trend.  However the conditions of Gluten allergy and Coeliac disease are not common in Southern India. Hence, the necessity of Gluten free diet in South Indian Population is under question. It is hypothesized that excessive millet usage could be a reason behind thyroid dysfunction and goitre. Regular millet only diet may also lead to a nutrition deprived state in people who are not gluten sensitive. Ayurveda also emphasizes on avoidance of regular use of Kudhanyas. This review comprises different aspects of dietary inclusion of Bajra. The properties and usability of Bajra as a gluten free diet, utility of Bajra in populations which are not gluten allergic and the effects of Bajra on health and disease form the core of this review.