14^th World Congress on Toxicology and Pharmacology March 12-14, 2018 Singapore

Biography:

Soma Sri Harsha is currently pursuing his MBBS from Saveetha Medical College, SIMATS. His area of research is in the field of drug development, under the mentorship of Dr. V Krishnan, Department of Pharmacology, SIMATS in India.

Abstract:

Modafinil, a non-amphetamine psycho-stimulant, is indicated for narcolepsy, shift work sleep disorder and severe obstructive sleep apnoea syndrome. Modafinil is prescribed at the dose of 100 mg once in a day or as two doses, 12 h apart in a day. Unlike classical stimulant medications like methylphenidate, modafinil has been thought to produce its wake-promoting effects independent of dopaminergic actions it has also been found that it reduces cocaine dependence and withdrawal phenomenon. Modafinil is a very beneficial medication and this particular finding in and of itself should not affect the way it is prescribed for the treatment of narcolepsy or even for the treatment in some instances off-label for (attention-deficit/hyperactivity disorder) ADHD or for cognitive impairment in patients with schizophrenia, because under those conditions, the patient is being monitored properly. However, it is directly pertinent to the concept of the misuse of modafinil, which is increasingly being utilized by healthy individuals with the expectation of improved cognitive performance. Modafinil is claimed to have very low liability for abuse and dependence. Here we report a rare case of modafinil dependence.

Biography:

Krithika M is currently pursuing her MBBS from Saveetha Medical College, SIMATS. Her area of research is in the field of experimental pharmacology, under the mentorship of Dr. Sankaran P, Department of Anatomy, SIMATS in India.

Abstract:

Infertility is a major public health concern. In Siddha System of Medicine many herbs were used for treating male sexual disorders. The use of herbs remarkable increased over the past few years and researcher now focuses on herbs. The present study was taken to analyze the fertility effect of an herb Cycas circinalis on male albino rats. A total of 18 healthy adult male albino rats were taken and divided into 3 groups with 6 rats in each group. One group of animal was administered orally Cycas circinalis extract (200 mg/kg bodyweight) and compared to the normal control and positive control albino rats given testosterone 10 µg/kg body weight subcutaneously. Various parameters were compared among the groups and the drug’s efficacy was analyzed. The administration of the drug showed significant positive results in positive control followed by experimental group. Since the synthetic hormonal preparation have grave side effects it’s better to go with herbal aphrodisiacs for better results without any side effects.

Biography:

Ozair Hassan is currently pursuing his MBBS from Saveetha Medical College, SIMATS. His area of research is in the field of Neuroscience, under the mentorship of Dr. Sankaran P, Department of Anatomy, SIMATS in India.

Abstract:

Long-term elevation of glucocorticoids hinders immune function, increasing the susceptibility to disease and neuro-degeneration. This study evaluated the hypothesized neuroprotective effect of antioxidant and piracetam, in chronic restraint stress induced rats. Healthy Wistar rats were divided into 4 groups (n=6) each. Group I was kept control. Stress group received chronic restraint stress for 6 hours per day for 21 days. Group III was administered vitamin E (40 mg/kg) and group IV was administered piracetam (336 mg/kg). Evaluation parameters were measurement of serum brain derived neurotrophic factor (BDNF) and serum nerve growth factor (NGF). The oxidative stress markers, SOD, CAT, glutathione peroxidase, glutathione reductase and malondialdehyde were measured. Serum nitric oxide levels were also measured. Histological analysis of CA1 region of hippocampus was done to evaluate the structural changes of pyramidal neurons. Spontaneous alteration behavior was analyzed using Y maze. The results revealed that vitamin E caused statistically significant (p<0.001) increase in serum BDNF and NGF and caused statistically significant (p<0.05) increase in antioxidant enzymes (catalase, super oxide dismutase, glutathione peroxidase, glutathione reductase), with significant (P<0.001) decrease in malondialdehyde concentrations. Vitamin E caused increase in neuronal cell size and volume in CA1 pyramidal layer of hippocampus and showed statistically significant (p<0.001) increase in spontaneous alteration behavior in Y maze. The findings of study are suggestive of neuroprotection, offered by administration of vitamin E compared to piracetam against chronic restraint stress induced rats. To conclude naturally available dietary vitamin might serve as an adjuvant therapy in order to avoid progression of brain damage during stress.

Biography:

Rithu Baskaran is currently pursuing her MBBS from Saveetha Medical College, SIMATS. Her area of research is drug development, under the mentorship of Dr. V Krishnan, Department of Pharmacology, SIMATS in India.

Abstract:

Introduction & Scope: In a report of by World Health Organization in 2003, detailed description of morbidity and mortality prevention of diarrheal illness among children by effectiveness of zinc is provided. Role of zinc in diarrheal illness when used approximately is evident by other pharmaco-epidemiologic studies as well. However, zinc should be administered as per dosage recommendation given vide infra in discussion and should be curtailed in adding with other nutraceuticals which is neither effective nor safe as zinc has its own adverse effects. Hence this observational study was conducted to analyze the currently available rational and essential zinc formulation in our country.

Objective: To critically analyze the essentiality and irrational zinc preparations available in Indian markets.

Methods: This was conducted as cross-sectional analysis by department of pharmacology of our tertiary care hospital between June and December 2016. Data regarding various formulations of zinc were retrieved from current index of medical sciences and drug India database. Rationality assessment was done using prescribed guidelines and approved formulations of zinc by Central drug standard control organization. Essentiality was checked using national list of essential medicine India, 2013 and latest version of WHO list essential medicine bulletin. Dosage regulation was assessed using Indian pharmacopeia guidelines, National Institute of Nutrition, India recommendation and upper daily intake toxicity intake, United States of America (USA).

Results: Our study results showed wide variation in the number of zinc preparation. Total number of formulation available in the market is 335. Among zinc preparation, the preparation that contains 20 mg of zinc as recommended by various guidelines is 10 in number. About 325 preparations of zinc are added with one or more nutraceuticals. None of these fixed dose combinations of zinc containing preparation is recommended as essential fixed regimen.

Conclusion: Zinc has lot of relevance in treating recurrent diarrheal illness, especially in pediatric cases, however legal, regulatory and educational measures should be followed to curtail all the irrational zinc prescription development, promotion, marketing and prescription.

Biography:

Karthikeyan Swaminathan is currently pursuing MBBS from Saveetha Medical College, SIMATS. His area of research revolves around clinical trials, carried out under the mentorship of Dr. V Krishnan, Department of Pharmacology, SIMATS in India.

Abstract:

Introduction: India is fast emerging as one of global hubs for conducting clinical trials. Even then, it is estimated that out of 1,18,804 clinical trials in 178 countries, less than 2,000 (<2%) are being done in India compared to 9,352 (8%) in neighboring China (WHO). Number of deaths resulting from clinical trials has increased to an unendurable figure of 2,868 during the period 2005-2012. Till April 2013, only 12 clinical trials have been approved by the authority as compared to almost a three digit figure in last year. This was a rationale to analyze the current trends of trials in India.

 

Objective: To review number of clinical trials in India from 2011 to 2016 and study designs and to note the number of serious adverse events and deaths due to clinical trials.

 

Methods: Data was collected and categorized from the clinical trial registry India-forum. In order to review the recent statistics and trend, only active trials that open to recruitment were included. Negative impact of trials on Indian trial participants (death/adverse events), data was obtained from official web of health and family welfare department.

Results: Our observational study shows there is steady decline in number of global clinical trials in India, from 56 to merely 19 in 2016. Majority were active controlled trials (61) and multiple arm trials than placebo based trials (7). SAE related to the trials were confirmed in 2209 cases by Drug Controller General of India including 1335 deaths.

Conclusion: Because of time-consuming government approvals and rising allegations of unethical tests further hindering possibilities of gathering a large sample size of people. Dr. Singh, Drug Controller General of India (DCGI), gave relaxed norms will help India register its presence in the international market as it will give Indian scientists and doctors the much needed liberty. With relaxed norms we will give more research opportunities to scientists in India without compromising ethics.

Biography:

Abirami Raghunath is currently pursuing her MBBS from Saveetha Medical College and Hospital, SIMATS. Her area of research is pharmacovigilance under the mentorship of Dr. V. Krishnan, Department of Pharmacology, SIMATS in India.

Abstract:

Flunarizine is one of the cerebro-selective calcium channel blockers, commonly prescribed for migraine prophylaxis in neurology clinics. It is considered as non-inferior to Propranolol and Amytriptyline when used to reduce the frequency of migraine attacks. Here we report a case of Flunarizine induced extrapyramidal syndrome and depression. A 37 year old female on tablet Flunarizine 15 mg daily for the past month to treat migraine, shows signs of depression and restlessness, propensity to bend, slow reactions and mask face. Depression was rated using patient health questionnaire and extrapyramidal syndrome was diagnosed by modified Simpson Angus scale and Barnes Akathisia Rating scale. Considering nil organic lesion and improvement of all symptoms with the cessation of Flunarizine, the case was diagnosed as Flunarizine induced depression and extrapyramidal disorder. Our case is unique in the way that our patient developed depression apart from mixed symptoms of extrapyramidal disorder. Exact mechanism of Flunarizine induced depression is not understood. Commonly, the onset of these symptoms varies from three months to twenty months after initiating treatment with Flunarizine, whereas in this case, symptoms were seen within the first month of treatment. Depression was evident even when the patient was on other antidepressants prescribed by a psychiatrist, namely Escitalopram and Buspirone. Symptoms improved only after cessation of Flunarizine from the prescription.

Biography:

Joseph Swithin Fernando is currently pursuing his MBBS from Saveetha Medical College. His area of research is Applied Pharmacology.

Abstract:

Mucuna pruriens is a climbing legume used in the treatment of various ailments. It is commonly known as cowitch or velvet bean. Traditionally, it was used in treating male infertility. The main aim of this study was to identify the bioactive materials present in the methanol extract of Mucuna pruriens seeds by gas chromatography mass spectrometry (GC-MS) technique. The analysis by GC-MS reveals the presence of 5 major compounds namely, pentadecanoic acid, 14-methyl-, methyl ester, dodecanoic acid, 9,12-octadecadienoic acid (Z,Z)-, methyl ester, 9,12-octadecadienoic acid and 2-myristynoyl-glycinamide. By comparing with the references of earlier studies, it was clear that these major compounds played a major role in its neuro-protective, antioxidant, anti-inflammatory, anticancer, hepato-protective and antimicrobial effects. The presence of antioxidants has been linked with neurogenesis in the brain. The presence of these compounds may authenticate the scientific evidences of many of its proposed therapeutic potentiality of the seeds of Mucuna pruriens (MP).

Biography:

Akshath S U is currently pursuing his MBBS from Saveetha Medical College, SIMATS. His research is on the hepato-protective effect of Phyllanthus niruri against the Paracetamol induced liver toxicity in albino rats under the mentorship of Dr. Sankaran, Department of Anatomy, SIMATS in India.

Abstract:

To investigate the mode of action of phyllanthus niruri as a prophylactic hepato-protective agent against Paracetamol (PCM) induced liver toxicity in albino rats. Five groups of six animals in each group of Wistar rats with a weight of 180-210 gm were the experimental material. Group I was served as normal control, administered sodium CMC for all the eight days. Group II rats were treated only with PCM at a dose of 2.5 gm/kg on 8^th day. Group III animals were administered silymarin at a dose of 50 mg/kg for eight days and PCM at a dose of 2.5 gm/kg on 8^th day, while Group IV is the treated group which was given P. niruri aqueous extract at a dose of 200 mg/kg followed by PCM of 2.5 gm/kg on 8^th day. Group V rats were administered with P. niruri at a dose of 400 mg/kg for eight days and PCM at a dose of 2.5 gm/kg on 8^th day. Biochemical, histological and immune-histological (IHC) examinations were performed. Histo-pathological picture is in line with the biochemical parameters and IHC study revealed that P. niruri acts by preventing the increase in NKT cells subsequently blocking FASL, by anti-apoptotic and by increasing regeneration. Phyllanthus niruri aqueous extract at a dose of 400 mg/kg was more effective than at 200 mg and silymarin 100 mg.

Biography:

Kumaresh Pandian is currently pursuing his MBBS from Saveetha Medical College, SIMAT. His area or research is Drug development under the mentorship of Dr. V Krishnan, Department of Pharmacology, SIMATS in India.

Abstract:

Objective: To analyze the post-marketing status of molecules approved through the expedited review process in the last quintile.

Methods: The observational study was carried out between January 2016 and June 2016. The details of the time taken to approve drugs were collected from the official website on the United States Food and Drug Administration (FDA). The average time taken to review drugs and take a decision following the review was ascertained from the FDA’s annual release of novel drugs from 2011 to 2015. Information on adverse drug reaction noted after approval was gathered from FDA Drug Safety Communication and FDA Adverse Event Reporting System (FAERS).

Results: In the last five years, 166 products were approved by expedited review. Of these 45 (27.1%) did not meet the stringent criteria framed for expedited review. Reports of serious adverse event alerts were submitted for 79 (47.5%) of the 166 molecules. 14 (8.4%) drugs were associated with inducing severe autoimmune disorders. It can be observed that a lower average time of review is positively correlated with a greater number of adverse events (p<0.05) and 37 (45.7%) of the molecules failed to be of any treatment scenario.

Conclusion: Drug approval by accelerated review should be stringent. Beneficence and non-maleficence are applicable to the global population and should apply equally to subjects involved in trials. Approving drugs on the basis of trivial evidence is non-scientific and absolutely unethical, since it can lead to clinical failure and produce serious adverse events.

Biography:

Keith Potent is currently a PhD candidate in Translational Research at Monash University. After completing undergraduate degrees in Mathematics and Chemistry, Dr Potent has completed his medical degree. He is a practicing doctor in Queensland.

Abstract:

We present a first in human case of a 50 year-old patient with end-stage metastatic ovarian cancer infused with a novel, intravenously administered, synthetically engineered bacteriophage-based gene therapy (Metavec) for metastatic solid malignancies. Compared to mammalian virus-based delivery vehicles, bacteriophage-based vectors bring many preferable features for treatment in humans. Their genomes have been extensively sequenced and, with modern technologies, they are relatively malleable allowing them to be extensively modified. Unlike mammalian viruses, bacteriophages are not natural pathogens to humans yet their capsid can have equivocal cargo carrying capacity. To the authors’ best knowledge, no other bacteriophage-based applications have succeeded with intravenous administration. This advance in nanotechnology and novel approach could revolutionize medical care. The patient we discuss received a dose-escalating regime up to 1x1011 particles per dose, three times a week for three weeks. The infusions were very well tolerated. Symptoms include nausea, low-grade fever, and also discomfort in areas where larger tumors were present. Post-infusion investigations included serum biochemistry, serum tumor markers, and computed tomography. The paradigm shift, results, and discussion will be presented.