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Perspectives in Clinical Research

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https://www.readbyqxmd.com/read/30319951/from-glivec-%C3%A2-to-prevnar-13-%C3%A2-how-strong-is-the-indian-drug-patenting-system
#1
Gerard Marshall Raj
No abstract text is available yet for this article.
October 2018: Perspectives in Clinical Research
https://www.readbyqxmd.com/read/30319950/study-designs-part-1-an-overview-and-classification
#2
Priya Ranganathan, Rakesh Aggarwal
There are several types of research study designs, each with its inherent strengths and flaws. The study design used to answer a particular research question depends on the nature of the question and the availability of resources. In this article, which is the first part of a series on "study designs," we provide an overview of research study designs and their classification. The subsequent articles will focus on individual designs.
October 2018: Perspectives in Clinical Research
https://www.readbyqxmd.com/read/30319949/investigator-initiated-studies-challenges-and-solutions
#3
Mahanjit Konwar, Debdipta Bose, Nithya J Gogtay, Urmila M Thatte
Investigator-initiated studies (IISs) help by generating data on effectiveness and safety of a drug in the real-world setting and attempt to answer questions that clinicians face in their day-to-day practice. These are studies that are initiated and managed by a nonpharmaceutical company researcher/s who could be an individual investigator, an institution or a group of institutions, and a collaborative study group or a cooperative group. They are largely driven by questions that arise beyond the completion of Phase III studies that have not been studied during Phases I-III of drug development...
October 2018: Perspectives in Clinical Research
https://www.readbyqxmd.com/read/30319948/materiovigilance-an-indian-perspective
#4
REVIEW
Bikash Ranjan Meher
Materiovigilance is the coordinated system of identification, collection, reporting, and analysis of any untoward occurrences associated with the use of medical devices and protection of patient's health by preventing its recurrences. Postmarketing surveillance of medical devices has been initiated in many countries, but it is still not as developed and robust as that of medicines. Materiovigilance program of India was launched on July 6, 2015, at Indian Pharmacopeia Commission with objectives to track the adverse events associated with the use of medical devices, to generate safety data, create awareness among the different stakeholders, and recommend the best practices and interventions to improve the patient's safety...
October 2018: Perspectives in Clinical Research
https://www.readbyqxmd.com/read/30319947/comparative-evaluation-of-pharmacovigilance-regulation-of-the-united-states-united-kingdom-canada-india-and-the-need-for-global-harmonized-practices
#5
REVIEW
Mohit Hans, Suresh Kumar Gupta
The primary focus of the pharmacovigilance (PV) practice has been on the collection, assessment, and reporting of the adverse drug reactions to medicinal products. Globalization of the pharmaceutical industry has prompted efforts to toward harmonization of PV practices worldwide to enable improved knowledge of medicine's benefit-risk profile and risk communication. Even as PV has evolved over the past decade, there still exist few areas of discordance across global PV practices. This article compares the PV legislation in the United States, United Kingdom, Canada, and India with a view to understand areas of harmony in the current legislation across regions and further compare health authorities' requirements with recommendations made by international organizations...
October 2018: Perspectives in Clinical Research
https://www.readbyqxmd.com/read/30319946/evaluation-of-treatment-outcome-and-adverse-drug-reaction-of-directly-observed-treatment-dot-plus-regimen-in-multidrug-resistant-tuberculosis-mdr-tb-patients-at-district-tuberculosis-centre-rajkot
#6
Kiran Gordhanbhai Piparva, Gaurav Jansari, Anil P Singh
Background: The emergence of drug-resistant mycobacteria becomes a significant public health problem globally creating an obstacle to effective tuberculosis (TB) control. Gujarat, Maharashtra, and Andhra Pradesh DRS survey estimated that the proportion of multidrug-resistant TB (MDR-TB) is 2.1% (in new TB cases) and 15% (in previously treated cases). Programmatic management of MDR-TB implemented under Revised National Tuberculosis Control Programme in India in 2007. Objectives: The objective of this study is to evaluate treatment outcome and adverse drug reactions (ADRs) of category IV...
October 2018: Perspectives in Clinical Research
https://www.readbyqxmd.com/read/30319945/comparison-of-efficacy-and-safety-of-topical-1-nadifloxacin-and-tretinoin-0-025-combination-therapy-with-1-clindamycin-and-tretinoin-0-025-combination-therapy-in-patients-of-mild-to-moderate-acne
#7
Swapnil Narayan Deshmukh, Vandana Avinash Badar, Manali Mangesh Mahajan, D Sujata Dudhgaonkar, Dharmendra Mishra
Background: Topical retinoids in combination with antimicrobials have been proven to reduce acne lesions faster and to a greater degree than antimicrobial therapy alone . Aims and Objectives: To compare the efficacy and safety of topical combination of 1% Nadifloxacin [NAD] and 0.025% Tretinoin [Tr] with 1% Clindamycin [CLN] and 0.025% Tr in patients of mild to moderate acne vulgaris of the face. Material and Methods: There were two groups (40 patients in each group): Group A received (NAD+Tr) combination therapy and group B received (CLN+Tr) combination therapy...
October 2018: Perspectives in Clinical Research
https://www.readbyqxmd.com/read/30319944/effect-of-telmisartan-on-blood-pressure-in-patients-of-type-2-diabetes-with-or-without-complications
#8
Pradeep Gadge, Roshani Gadge, Nikita Paralkar, Preeti Jain, Vrunda Tanna
Introduction: Telmisartan is one of the preferred choices of antihypertensive in patients of diabetes with hypertension (HTN) and lowers blood pressure (BP) effectively. Objective: The objective of the study was to determine BP-lowering efficacy of telmisartan monotherapy in patients of Stage I HTN with or without complications of type 2 diabetes mellitus (T2DM). Materials and Methods: In this retrospective study, patients of T2DM without (Group A) or with (Group B) complications who had Stage I HTN and were prescribed telmisartan (20-80 mg/day) treatment were identified from database...
October 2018: Perspectives in Clinical Research
https://www.readbyqxmd.com/read/30319943/drug-resistant-tuberculosis-a-ticking-time-bomb
#9
EDITORIAL
Srikanth Krishnamurthy
No abstract text is available yet for this article.
October 2018: Perspectives in Clinical Research
https://www.readbyqxmd.com/read/30090716/plagiarism-either-intentional-or-unintentional-it-is-still-plagiarism
#10
Beuy Joob, Viroj Wiwanitkit
No abstract text is available yet for this article.
July 2018: Perspectives in Clinical Research
https://www.readbyqxmd.com/read/30090715/indian-regulatory-update-january-march-2018
#11
Amita Bhave
No abstract text is available yet for this article.
July 2018: Perspectives in Clinical Research
https://www.readbyqxmd.com/read/30090714/understanding-diagnostic-tests-part-3-receiver-operating-characteristic-curves
#12
Rakesh Aggarwal, Priya Ranganathan
In the previous two articles in this series on biostatistics, we examined the properties of diagnostic tests and various measures of their performance in clinical practice. These performance measures vary according to the cutoff used to distinguish the diseased and the healthy. We conclude the series on diagnostic tests by looking at receiver operating characteristic curves, a technique to assess the performance of a test across several different cutoffs, and discuss how to determine an optimum cutoff.
July 2018: Perspectives in Clinical Research
https://www.readbyqxmd.com/read/30090713/polypharmacy-and-comorbidity-status-in-the-treatment-of-type-2-diabetic-patients-attending-a-tertiary-care-hospital-an-observational-and-questionnaire-based-study
#13
Rania Indu, Anjan Adhikari, Indira Maisnam, Piyali Basak, Tapas Kumar Sur, Anup Kumar Das
Purpose/Aim: Diabetes mellitus is associated with several comorbid conditions. Thus, often, diabetic patients are prescribed multiple drugs. Although multiple drugs help to combat various diseases, they also increase the propensity of drug interactions and adverse drug reactions. The present study thus tried to evaluate the comorbid conditions and concurrent medications associated with type 2 diabetic patients. It also aimed to address patient compliance for the medications provided to them...
July 2018: Perspectives in Clinical Research
https://www.readbyqxmd.com/read/30090712/drug-prescription-pattern-of-outpatients-in-a-tertiary-care-teaching-hospital-in-tamil-nadu
#14
S Shanmugapriya, T Saravanan, S Saranya Rajee, R Venkatrajan, Pinky Mariam Thomas
Purpose: Drug use prescribing indicators advocated by the World Health Organization (WHO) are important tools for assessing the degree of polypharmacy, use of generic medicines, and to evaluate if there is inappropriate use of antibiotics or parenteral medications besides estimating the adherence to the essential drugs list. This study aimed to assess the WHO prescribing indicators in prescriptions given at the medical outpatient department (OPD) in a private medical college hospital in South India...
July 2018: Perspectives in Clinical Research
https://www.readbyqxmd.com/read/30090711/knowledge-and-attitudes-of-indian-surgeons-regarding-professional-medical-writing-support
#15
Natasha Das, Saurendra Das
Aim: The number of scientific papers published from India each year is low. We tried to determine how often Indian surgeons publish in biomedical journals, challenges preventing them from publishing more often, their awareness of the international guidelines that acknowledge professional medical writing as an ethical service, and their willingness to hire medical writers for their publications. Materials and Methods: A convenience sample of 100 of the surgeons attending a national conference were explained about the survey and asked to complete a survey questionnaire...
July 2018: Perspectives in Clinical Research
https://www.readbyqxmd.com/read/30090710/an-analysis-of-completeness-and-quality-of-adverse-drug-reaction-reports-at-an-adverse-drug-reaction-monitoring-centre-in-western-india
#16
Manali Mangesh Mahajan, Urmila Mukund Thatte, Nithya Jaideep Gogtay, Siddharth Deshpande
Purpose/Aim: The Adverse Drug Reaction [ADR] form is the source document for the Pharmacovigilance Programme of India [PvPI] and captures information first hand from the patient. The raw data from it then gets converted into an individual case safety report [ICSR] after entry into Vigiflow. The National Coordinating Centre [NCC] uses an instrument to assess quality of these ICSRs. We carried out the present study to assess whether the same instrument with minor modifications could be used to check the quality of ADR forms at our centre...
July 2018: Perspectives in Clinical Research
https://www.readbyqxmd.com/read/30090709/my-40-year-journey-in-diabetes-research-the-power-of-collaboration
#17
Viswanathan Mohan
This article describes a 40 year journey in diabetes research of an Indian diabetologist, starting as an undergraduate medical student. The article describes how collaborations with multiple stake-holders is necessary if one is to advance one's research from the simple studies that one starts with and take it to higher and higher levels. It is also essential that the seeds for doing research are planted early in a medico's life even during undergraduate days, as only then will more doctors take up medical research as a career...
July 2018: Perspectives in Clinical Research
https://www.readbyqxmd.com/read/30090708/professional-medical-writing-support-the-need-of-the-day
#18
EDITORIAL
Suhasini Sharma
No abstract text is available yet for this article.
July 2018: Perspectives in Clinical Research
https://www.readbyqxmd.com/read/29862207/author-s-reply
#19
Chetna Desai
No abstract text is available yet for this article.
April 2018: Perspectives in Clinical Research
https://www.readbyqxmd.com/read/29862206/antidiabetic-medication-and-quality-of-life-a-comment-on-chaturvedi-et-al-2018
#20
Saurav Basu
No abstract text is available yet for this article.
April 2018: Perspectives in Clinical Research
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