
Nithya J GogtayKEM Hospital · Department of Clinical Pharmacology
Nithya J Gogtay
MD, DNB, DNB (Clinical Pharmacology), PhD, FRCP
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Publications (281)
AZD1222 (ChAdOx1 nCoV-19) is a replication-deficient adenoviral vectored coronavirus disease-19 (COVID-19) vaccine that is manufactured as SII-ChAdOx1 nCoV-19 by the Serum Institute of India Pvt Ltd following technology transfer from Oxford University/AstraZeneca. The non-inferiority of SII-ChAdOx1 nCoV-19 with AZD1222 was previously demonstrated i...
AZD1222 (ChAdOx1 nCoV-19) is a replication-deficient adenoviral vectored coronavirus disease-19 (COVID�19) vaccine that is manufactured as SII-ChAdOx1 nCoV-19 by the Serum Institute of India Pvt Ltd following
technology transfer from Oxford University/AstraZeneca. The non-inferiority of SII-ChAdOx1 nCoV-19 with
AZD1222 was previously demonstrated...
Background
NVX-CoV2373, a Covid-19 vaccine was developed in the USA with ∼90% efficacy. The same vaccine is manufactured in India after technology transfer (called as SII-NVX-CoV2373), was evaluated in this phase 2/3 immuno-bridging study.
Methods
This was an observer-blind, randomised, phase 2/3 study in 1600 adults. In phase 2, 200 participants...
Background: This phase2/3immunobridgingstudyevaluatedthesafetyandimmunogenicityoftheChAdOx1
nCoV-19 CoronavirusVaccine(Recombinant)(SII-ChAdOx1nCoV-19),manufacturedinIndiaattheSerum
Institute ofIndiaPvtLtd(SIIPL),followingtechnologytransferfromtheAstraZeneca.
Methods: This participant-blind,observer-blindstudyrandomisedparticipants3:1toSII-ChAdOx1n...
The present audit was carried out with the objective of evaluating warning letters (WLs) issued to trial sponsors, clinical investigators and institutional review boards (IRBs) by the United States Food and Drug Administration during a six-year period and compare it with two similar earlier audits. WLs were reviewed and classified as per stakeholde...
Background: This phase 2/3 immunobridging study evaluated the safety and immunogenicity of the ChAdOx1
nCoV-19 Coronavirus Vaccine (Recombinant) (SII-ChAdOx1 nCoV-19), manufactured in India at the Serum
Institute of India Pvt Ltd (SIIPL), following technology transfer from the AstraZeneca.
Methods: This participant-blind, observer-blind study rando...
Introduction
Hydroxychloroquine (HCQ) has recently become the focus of attention in the current COVID-19 pandemic. With an increase in the off-label use of HCQ, concern for the safety of HCQ has been raised. We, therefore, performed this systematic review to analyze the safety data of HCQ against placebo and active treatment in various disease cond...
Background
An interim analysis is an integral component of clinical research and drug development in particular and helps reduce ‘time to market’ for intervention or stop further development of unsafe and ineffective interventions. In this audit, we evaluated the extent of the use of interim analyses in published RCTs in three leading journals and...
Urinary tract infections (UTI) are among the most frequent medical conditions requiring outpatient treatment. Single dose oral fosfomycin (300 mg) and the older nitrofurantoin (100 mg for 5 days) have been found to be more effective than other first-line drugs in multiple studies. This systematic review and meta-analysis were carried out with the o...
Abstract
Objectives: We evaluated the extent of consent declines and consent withdrawals during the COVID-19 pandemic as seen in published randomized controlled trials (RCTs) and compared it with non-COVID-19 RCTs published at the same time and two historical controls.
Methods: PubMed/Medline only was searched using key-word "COVID-19" and "RCTs"...
Bisphosphonates (BPs) have been in the market for the past 40 years and proven beneficial especially for patients with osteoporosis and prevention of hypercalcemic in malignancy. However, their long-term use raises safety concerns like Atypical femoral fracture and Osteonecrosis of the Jaw whose pathophysiology still remains unclear. Atypical femor...
Background and Objectives
An innovative intranasal aqua-triggered in-situ (ATIS) gel is a polymer-free in-situ gelling microemulsion which gels instantaneously on contact with minute quantities of water to form a mucoadhesive gel. The objective of the study was to develop ATIS diazepam (ATIS-diazepam) as an alternative to the injection for epilepti...
Drug development is a tedious and expensive procedure and it takes roughly 10 to 15 years to take a
potential treatment from bench to bedside and costs the pharmaceutical companies as much as USD ~2
billion for the process. Delay in investigator-initiated studies can cause financial loss to grant providers
(either public or private) and investigato...
Principles and Practice presents the latest scientific advances in molecular and cellular biology, including the development of new and effective drug and biological therapies and diagnostic methods. The book provides medical and biomedical students and researchers with a clear and clinically relevant understanding on the molecular basis of human d...
Rationale:
Vancomycin remains the standard of care for gram-positive bacterial infections, though there are significant developments in newer antibacterial agents. Efficacy can be improved by linking pharmacokinetic with pharmacodynamic principles, thus leading to optimum antibiotic exposure. There is scarcity of pharmacokinetic data in Indian int...
Aims and objectives:
Vancomycin is a drug of choice for various gram-positive bacterial (GPB) infections and is largely prescribed to pediatric intensive care unit (PICU) patients. Despite the different pathophysiology of these patients, limited data are available on pharmacokinetics of vancomycin. There are lack of data for critically ill Indian...
BACKGROUND: Tacrolimus has narrow therapeutic index, and its dosing is associated with polymorphisms of liver enzyme CYP3A5.
AIM OF THE STUDY: Association of CYP3A5 genotype with renal graft outcome and tacrolimus trough levels; assess prevalence of CYP3A5 polymorphisms.
METHODS: Informed consent was obtained from renal-transplant recipients (4–8...
Aims:
The primary objective of this study was to evaluate the economic burden of slow learners (students with "borderline intellectual functioning") by estimating its direct, indirect, and intangible costs. The secondary objective was to assess the impact of variables on the economic burden.
Settings and design:
Cross-sectional, single-arm descr...
Aims:
The primary objective of the present study was to evaluate the economic burden of specific learning disability (SpLD) by estimating its direct, indirect, and intangible costs. A secondary objective was to assess the impact of variables on the economic burden.
Settings and design:
Cross-sectional single-arm descriptive study.
Setting:
Lea...
Unlike developed nationsmost of whom put into place systems of pharmacovigilance in the early 1960s following the thalidomide disaster, India's Pharmacovigilance Program formally began only in the mid-1980s. After several unsuccessful attempts, a robust program was put in place by the Central Drugs Standard Control Organization in 2010 called the P...
Background:
A newly developed bovine-human reassortant pentavalent vaccine (BRV-PV, ROTASIIL®) was tested for its potential effect on the immunogenicity of concomitantly administered EPI vaccines in infants in a randomized controlled study in India.
Methods:
In this Phase III, multicenter, open label, randomized, controlled study, three doses of...
Aim:
Anxiety disorders usually remain undiagnosed in school students owing to the internalized nature of their symptoms. The present study was conducted with the primary objective of evaluating the prevalence of anxiety symptoms in school students in Mumbai. A secondary objective was to assess the impact of variables (age, gender, presence of sibl...
Aim: Anxiety disorders usually remain undiagnosed in school students owing to the internalized nature of their symptoms. The present study was conducted with the primary objective of evaluating the prevalence of anxiety symptoms in school students in Mumbai. A secondary objective was to assess the impact of variables (age, gender, presence of sibli...
Objective
Genetic polymorphisms of CYP2C9 and VKORC1 play major role in pharmacokinetics and pharmacodynamics of warfarin, respectively. Purpose of our study was to assess the utility of pretesting patients for the above mutations in predicting tendency for bleeding and achieving target INR.
Methods
This was an audit of data collected between July...
Lymphatic filariasis (LF) affects 73 countries, causes morbidity and impedes socioeconomic development. We had found no difference in safety and micro (Mf) and macro filarial action of single-dose diethylcarbamazine (DEC) and DEC + albendazole (ABZ) in an F01 study done in India (year 2000). There was a programmatic need to evaluate safety and effi...
Multivariate analysis refers to statistical techniques that simultaneously look at three or more variables in relation to the subjects under investigation with the aim of identifying or clarifying the relationships between them. These techniques have been broadly classified as dependence techniques, which explore the relationship between one or mor...
Survival analysis is concerned with "time to event" data. Conventionally, it dealt with cancer death as the event in question, but it can handle any event occurring over a time frame, and this need not be always adverse in nature. When the outcome of a study is the time to an event, it is often not possible to wait until the event in question has h...
In observational studies, as well as in interventional ones, it is frequently necessary to estimate risk that is the association between an observed outcome or event and exposure to one or more factors that may be contributing to the event. Understanding incidence and prevalence are the starting point in any discussion of risk assessment. Incidence...
Background: Genetic polymorphisms in drug metabolizing enzymes (DMEs) impart distinct drug metabolizing capacity and a unique phenotype to an individual. Phenytoin has large inter-individual variability in metabolism due to polymorphisms in CYP2C9 and CYP2C19. As per Ayurveda, Prakriti imparts a unique phenotype to an individual.
Objective: To asse...
Crucial therapeutic decisions are based on diagnostic tests. Therefore, it is important to evaluate such tests before adopting them for routine use. Although things such as blood tests, cultures, biopsies, and radiological imaging are obvious diagnostic tests, it is not to be forgotten that specific clinical examination procedures, scoring systems...
Correlation and linear regression are the most commonly used techniques for quantifying the association between two numeric variables. Correlation quantifies the strength of the linear relationship between paired variables, expressing this as a correlation coefficient. If both variables x and y are normally distributed, we calculate Pearson′s corre...
Determining the appropriate sample size for a study, whatever be its type, is a fundamental aspect of biomedical research. An adequate sample ensures that the study will yield reliable information, regardless of whether the data ultimately suggests a clinically important difference between the interventions or elements being studied. The probabilit...
Background:
Rabies is a 100% fatal disease but preventable with vaccines and immunoglobulins. We have developed a new purified vero cell rabies vaccine (Rabivax-S) and evaluated its safety and immunogenicity in post-exposure prophylaxis by intramuscular (IM) and intradermal (ID) routes.
Methods:
This was a randomized active-controlled non-inferi...
Introduction: CYP2C19 and P2Y12 polymorphisms have been claimed to alter the pharmacodynamic response to clopidogrel. ABCB1 polymorphism has been associated with the efflux of clopidogrel resulting in decreased bioavailability. Due to paucity of data from Indian population, the present study was undertaken to evaluate the association of genetic pol...
Categorical variables are commonly represented as counts or frequencies. For analysis, such data are conveniently arranged in contingency tables. Conventionally, such tables are designated as r × c tables, with r denoting number of rows and c denoting number of columns. The Chi-square (χ2 ) probability distribution is particularly useful in analyzi...
Objectives: Cytochrome P450 2C9 (CYP2C9) is a member of cytochrome P450 (CYP) family that accounts for nearly 18% of the total CYP protein content in the human liver microsomes and catalyzes almost 15–20% of the drugs. Considering the paucity of data on the polymorphisms of CYP2C9 in Western Indian population, the present study was conducted to eva...
Numerical data that are normally distributed can be analyzed with parametric tests, that is, tests which are based on the parameters that define a normal distribution curve. If the distribution is uncertain, the data can be plotted as a normal probability plot and visually inspected, or tested for normality using one of a number of goodness of fit...
In Plasmodium vivax malaria, mechanisms that trigger transition from uncomplicated to fatal severe infections are obscure. In this multi-disciplinary study we have performed a comprehensive analysis of clinicopathological parameters and serum proteome profiles of vivax malaria patients with different severity levels of infection to investigate path...
Deoxyribonucleic acid [DNA] and ribonucleic acid [RNA] are simple linear polymers that have been the subject of considerable research in the last two decades and have now moved into the realm of being stand-alone therapeutic agents. Much of this has stemmed from the appreciation that they carry out myriad functions that go beyond mere storage of ge...
Hypothesis testing (or statistical inference) is one of the major applications of biostatistics. Much of medical research begins with a research question that can be framed as a hypothesis. Inferential statistics begins with a null hypothesis that reflects the conservative position of no change or no difference in comparison to baseline or between...
Introduction: Various factors have been shown to increase the risk of bleeding with warfarin. This study aimed to assess the association of CYP2C9 and VKORC1 with the development of bleeding following warfarin. Study Methods: A case control study was initiated after obtaining institutional ethics committee clearance and written informed consent fro...
Note: This editorial is being published simultaneously in the Indian Heart Journal, Indian Journal of Anaesthesia, Indian Journal of Gastroenterology, Indian Journal of Medical Ethics, Indian Journal of Medical Microbiology, Indian Journal of Occupational and Environmental Medicine, Indian Journal of Pathology and Microbiology, Indian Journal of Ph...
Background
Chloroquine has been the treatment
of choice for acute vivax malaria for more than 60 years. Malaria caused by Plasmodium vivax has recently shown resistance to chloroquine in some places. This study compared the efficacy and safety of fixed dose combination (FDC) of arterolane maleate and piperaquine phosphate (PQP) with chloroquine in...
Objectives: Cytochrome P4502E1 (CYP2E1) is involved in the metabolism of isoniazid and the mediation of its hepatotoxicity. It exhibits genetic polymorphism in humans. This study evaluated the polymorphism of CYP2E1 in adult healthy Western Indians and patients on antituberculous drugs by phenotyping and genotyping.
Methods: A 500 mg single dose of...
Although application of statistical methods to biomedical research began only some 150 years ago, statistics is now an integral part of medical research. A knowledge of statistics is also becoming mandatory to understand most medical literature. Data constitute the raw material for statistical work. They are records of measurement or observations o...
Introduction: Various factors have been shown to increase the risk of bleeding with warfarin. This study aimed to assess the association of CYP2C9 and VKORC1 with the development of bleeding following warfarin. Study Methods: A case control study was initiated after obtaining institutional ethics committee clearance and written informed consent fro...
We are grateful to Dr Green and colleagues for their comments.1 2 We understand the dangers of malaria.3 It is gratifying that no operational British service personnel have died from malaria for two decades, although this may indicate better treatment, not effective prophylaxis.
Mefloquine was adopted by the …
Abstract is a vital part of a research paper. Besides the title, it is the most widely read section of an article. The first impressions created by the abstract on editors and reviewers can have a great influence on the fate of the article. After its publication, a reader might decide to give the article a miss, if he finds the information provided...
Not the first choice
The British Army adopted mefloquine (Lariam) as its preferred drug for chemoprophylaxis against malaria in 1993. Treatment doses of mefloquine had already been reported to cause an acute brain syndrome.1 In 1996, army doctors reported a private soldier who, after six doses of mefloquine prophylaxis, saw the Grim Reaper standin...
Background and objectives:
School students with specific learning disabilities (SpLDs) experience chronic academic underachievement and resultant stress. The present study aimed to determine if school students with newly diagnosed SpLD were more likely to have anxiety than their regular peers.
Materials and methods:
The study cases (aged 8-15 ye...
Background and rationale:
Ensuring research participants' autonomy is one of the core ethical obligations of researchers. This fundamental principle confers on every participant the right to refuse to take part in clinical research, and the measure of the number of consent refusals could be an important metric to evaluate the quality of the inform...
Liver biopsy is the gold standard for detecting fibrosis in patients with nonalcoholic fatty liver disease (NAFLD). Due to limitations of biopsy, various combinations of serum markers have been studied to predict liver fibrosis; many of these are patented and expensive, thereby restricting their evaluation. We prospectively evaluated the correlatio...
Background. Primaquine is used to eradicate latent Plasmodium vivax parasite from liver, with administration of standard dose daily up to 14 days. We studied efficacy, safety, and tolerability of sustained release (SR) formulation of primaquine in comparison with conventional primaquine in preventing relapse of P. vivax malaria. Methods. Microscopi...
This phase 3, multi-center, open-label study evaluated the immunogenicity and safety of a quadrivalent meningococcal conjugate vaccine (MenACWY-CRM, Menveo(®), Novartis Vaccines and Diagnostics Srl, Siena, Italy) in healthy Indian subjects aged 2-75 years to provide data for licensure in India.
A total of 180 subjects were enrolled (60 subjects 2-1...
India significantly contributes to the global malaria burden and has the largest population in the world at risk of malaria. This study aims to analyze alterations in the human serum proteome as a consequence of non-severe and severe infections by the malaria parasite Plasmodium falciparum to identify markers related to disease severity and to obta...
Plasmodium vivax is the most dominating species in the Indian subcontinent among the five Plasmodium species causing malarial infection in humans.
This species is generally believed to be benign and classically thought to cause uncomplicated clinical infection that rarely leads to death or other complication. However, recent studies have shown inci...