CR Articles

BRIEF REVIEW ON CLINICAL TRIALS

About Author:Ratnadeep V. Ghadage.
Department of Pharmaceutical Chemistry,
Appasaheb Birnale College of Pharmacy, Sangli,
Maharashtra, India

ABSTRACT:
Any investigation in human subjects intended to discover or verify the clinical, pharmacological and/or other pharmacodynamic effects of an investigational product(s), and/or to identify any adverse reactions to an investigational product(s), and/or to study absorption, distribution, metabolism, and excretion of an investigational product(s) with the object of ascertaining its safety and/or efficacy. The terms clinical trial and clinical study are synonymous. Clinical trials examine the safety and efficacy of interventions, or treatments, in human subjects. This manuscript focuses on pharmaceutical clinical trials. The word subject is used deliberately here, since all participants in clinical trials are subjects, even if they are under the care of a personal physician, and therefore patients in that context, at the time of the trial. The pharmaceutical industry is now a more significant investor in clinical trials, but in addition to these opportunities, it is being challenged by the financial impact of managed care and medicaid regulations on academic medical-center revenues. Besides that, there is growing public concern about our systems for protection of human subjects, along with some conflicts. There are public expectations that clinical research will yield substantial advances in the health of the public. Once clinical research studies are completed and a drug has been approved for marketing by a regulatory agency, reports of the drug’s safety and efficacy will be published in the clinical literature. This dissemination of the results provides clinicians and research scientists with evidence of the beneficial administration of the drug.

A Case Report on Comorbidities and Laboratory Abnormalities of Lamivudine in Hepatitis B Patients

About Authors:Dhaval Patel*[1], Pratham Rathore[1], Prerna Sharma[1], Dr. Pankaj Shah[2]
1 Department of Pharmacy Practice,
School of Pharmaceutical Sciences,
Jaipur National University,
Jaipur -302025, (Rajasthan), India
2 Institute of kidney disease and research center,
civil hospital, Ahmedabad, (Gujarat), India

Abstract
Inpresent study, comorbidities and laboratory abnormalities of lamivudine was analysed in hepatitis b patients. Clinical data were collected from hepatitis b patients that presented with laboratory abnormalities to lamivudine. We examined 100 patients of hepatitis b who treated with lamivudine in i.k.d.r.c, civil hospital, Ahmedabad from January 2009 to February 2011. The main laboratory abnormalities were elevation of creatine kinase, elevation of AST, elevation of serum lipase. Hypertension was the major comorbidities with the hepatitis b. The laboratory abnormalities were related to lamivudine, but the biological mechanism of the reaction is not clear.

Correlation of Serum Magnesium Level with Increase in Parity and Comparision Among Rural and Urban Pregnant Women

About Author: Main author: Amar Nagesh Kumar,
Lecturer, Department of Biochemistry,
SSR Medical College, Belle Rive, Mauritius
Co-author: Robby Kumar,
Lecturer, Department of Biochemistry,
SSR Medical College, Belle Rive, Mauritius

Abstract
Objective: To correlate serum magnesium levels among pregnant women with increasing parity and comparison of magnesium levels in rural and urban areas of Guntur district, Andhra Pradesh, India.

Materials and Methods: A total of 100 pregnant women with pregnancy duration of 24 weeks and more were enrolled for the study. Blood from the antecubital vein was drawn and serum magnesium levels were estimated by the colorimetric method.

Results: In all, 48% of the pregnant women had serum levels less than the normal level (1.80 mg/dl). There was a significant decrease in serum magnesium levels with the increase in parity. But no significant decrease of magnesium level in serum was found when compared among rural and urban pregnant women.

Memory Enhancing Activity of Methanolic Extract of Selaginella Bryopteris in Swiss Albino Mice

About Author: Neeraj Kumar Garg*1, Pankaj Khatri1, Sangeeta Gupta2, N. Ganesh2
1. School of pharmacy, Suresh Gyan Vihar University, Mahal, Jagatpura, Jaipur (Raj.)
2. Incharge, Department of research, jawahar lal Nehru cancer Hospital and Research centre, Idgah hills Bhopal 462001 (M.P.)

Abstract
Alzheimer disease (AD) is a neurodegenerative disorder currently without an effective treatment. Impairment of memory is the initial and most significant symptom of Alzheimer disease (AD). The present study was under taken to investigate the effect of Selaginella bryopteris (popularly known as sanjeevani, Family: Selaginellaceae) on learning and memory. Two doses (250 and 500 mg/kg p.o.) of methanolic extract of Selaginella bryopteris were administered for 7 successive days in separate group of animals. The dose of 500 mg/kg p.o. of the methanolic extract of Selaginella bryopteris significantly improved learning and memory of mice. Antioxidant property of Selaginella bryopteris may be contributing favourably to the memory enhancement effect. However, further studies are necessitated to identify the exact mechanism of action. In the present investigation of Selaginella bryopteris have shown promising memory enhancing agent in the entire laboratory models employed.

“The Unknown Mystery of Death - Risk Factor for Development of Cancer Cervix in Indian Women.”

About Author: Rinki Verma (Research fellow)
Institute of Medical science (CEMS)
Banaras Hindu University
Varanasi - 221005

Abstract
India, the disease accounts for an estimated 24 percent of India’s cancer cases among women and additionally 74,000 indian women die annually from the disease, which results from the abnormal growth of cells in the cervix (the narrow opening of the uterus or womb). Cervical cancer is the most common disorder among middle-aged women which increased the mortality rate  in  Indian rural women as compared urban due to lack of  their awareness and  don’t acquire appropriate education .  Uncontrolled growth (cancer) in the cervix is not a single type. It is not usually associated with hereditary genetic factor but also a number of other factors (Chemical, Physical , environmental and biological ) indirectly heighten the risk of cervical cancer by increasing the likelihood that a woman will contract an HPV infection. These factors include early age at first intercourse and multiple sex partners. National Cancer Control Program emphasizes the importance of early detection and treatment. But the country has no organized screening program, and many Indian women lack information about the disease and access to prevention and treatment facilities. Therefore, it is most of important to reduced rate of women mortality through proper management.

Prescription Monitoring of Antihypertensive Drug Utilization for Uncomplicated Hypertension Patients in a Tertiary Hospital: A Cross Sectional Study in the Inpatient Wards

About Authors: N. V. R. Praveen Kumar. T, Mohanta. G. P, Sudarshan. S# and Parimalakrishnan. S.
Department of Pharmacy, Annamalai University,
Annamalai Nagar – 608002.Tamil Nadu, India.
# Department of Medicine, Rajah Muhtiah Medical College and Hospital, Annamalai University,
Annamalai Nagar – 608002.Tamil Nadu, India.

Reference ID: PHARMATUTOR-ART-1079

Abstract
Objective
The study was conducted to identify and evaluate the Prescription Monitoring of Antihypertensive Drug Utilization for Uncomplicated Hypertension Patients.

Methodology
This was a prospective observational study and was approved by IRB.  The study was conducted in tertiary care teaching hospital, which is located at southern part of India having 1210 beds.  Totally 1262 prescriptions were studied.

Results
Total distribution of patients with respect to age group showed that highest number of patients was found in the age group of 60-69 years (31.3%) and least was found between 20-29 years age group (1.1%). Majority of males in the study population (43.29%) were found to have both the habits of smoking and alcohol. Among concomitant diseases that were related to hypertension Coronary artery disease was highest (67.78%) and giddiness was least (1.7%). In case of diseases unrelated to hypertension Type II diabetes mellitus was observed as highest (38.7%) and acute gastroenteritis was recorded least (5.68%). Overall 43.5% patients were treated with single antihypertensive drug and 53.8% were treated with antihypertensive drug combinations.

PHARMACOVIGILANCE AN OVERVIEW

About Authors: * Ryali. Jithendra, Dinesh Kumar. Pandurangan, Bandaru. Sowjanya1, Vijayaraj Kumar. Perumal2
1Department of Biotechnology, Acharya Nagarjuna University, Guntur – 522 510, India,
*1-Department of Pharmaceutics, Rahul Institute of Pharmaceutical Science & Research, Chirala-523157, Andhra Pradesh, India.
2-School of Pharmacy, University College Sadaya International,Kuala Lumpur, Malaysia.

ABSTRACT:
Pharmacovigilance is an important and integral part of clinical research. Pharmacovigilance is “defined as the pharmacological science relating to the detection, assessment, understanding and prevention of adverse effects, particularly long term and short term adverse effects of medicines. This addresses what exactly is pharmacovigilance?  What do we know of its benefits and risks, challenges and the future hold for pharmacovigilance in Indian medicine. Here the main focus on the aims and role of pharmacovigilance in medicines regulation and their Partners. This article describes and discusses the National programme of pharmacovigilance and centre in India. There role in collecting the reports ADRs of medicines. Further effectiveness and risk assessments of therapies are been discussed. The important role played by health care professional, pharmaceutical industries, media, and programmes carried by WHO. Finally the conclusion describes the major challenges and achievements for the future pharmacovigilance programme.

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