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   2013| October-December  | Volume 4 | Issue 4  
    Online since October 10, 2013

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How to calculate sample size in animal studies?
Jaykaran Charan, ND Kantharia
October-December 2013, 4(4):303-306
DOI:10.4103/0976-500X.119726  PMID:24250214
Calculation of sample size is one of the important component of design of any research including animal studies. If a researcher select less number of animals it may lead to missing of any significant difference even if it exist in population and if more number of animals selected then it may lead to unnecessary wastage of resources and may lead to ethical issues. In this article, on the basis of review of literature done by us we suggested few methods of sample size calculations for animal studies.
  31,021 8,564 145
Three-way, three-period, crossover bioequivalence study of single oral dose of three brands of 300 mg phenytoin sodium tablets marketed in India, on healthy Indian human volunteers
Maulik S Doshi, Anuja A Naik, Mohit R Mehta, Nithya J Gogtay, Urmila M Thatte, Mala D Menon
October-December 2013, 4(4):243-246
DOI:10.4103/0976-500X.119709  PMID:24250200
Objective: To compare the bioavailability of two brands of phenytoin sodium tablets available in the Indian market using Eptoin TM as the reference. Materials and Methods: A randomized, assessor-blind, three-way crossover design study was carried out over a period of 6 months after approval from the Institutional Review Board (IRB). Twenty-two healthy male participants received a single oral 300 mg oral tablet of either of the formulations with a 2-week washout. Blood samples were collected predose and at regular intervals postdose. Plasma phenytoin levels were estimated by high-performance liquid chromatography. Calculation of C max , AUC 0-t , and AUC 0-∞ was done by the linear trapezoidal rule and 90-110% margin (90% confidence interval (CI)) was used to assess bioequivalence. Results: Twenty volunteers completed the study. It was seen that the log-transformed values of C max , AUC 0-t , and AUC 0-∞ of the test formulations were not within the specified limits. Conclusion: Bioinequivalence of available phenytoin brands indicates that switching brands could lead to variations in blood concentrations and thus impact safety and efficacy. If a brand switch is done for any reason, stringent drug-level monitoring is advised.
  6,969 743 1
Cabazitaxel: A novel taxane for metastatic castration-resistant prostate cancer-current implications and future prospects
Afroz Abidi
October-December 2013, 4(4):230-237
DOI:10.4103/0976-500X.119704  PMID:24250198
Recent advances in the management of prostate cancer have shown considerable development with time and many novel therapeutic agents have been approved over the past years. For patients with metastatic castration-resistant prostate cancer (mCRPC), initially docetaxel was the standard chemotherapy but once they became refractory to docetaxel, no treatment improved survival. This scenario changed in June 2010 when the US Food and Drug Administration (FDA) approved Cabazitaxel as a new therapeutic option for patients with mCRPC resistant to docetaxel. Cabazitaxel, being a novel tubulin-binding taxane with poor affinity for P-glycoprotein, decreases the chances of resistance. It has shown antitumor activity in preclinical, phase I, II and III clinical studies in docetaxel-resistant tumors. This article summarises the background, pharmacodynamic, kinetics and clinical development of cabazitaxel for the treatment of castration-resistant prostate cancer. Future development and rational use of this drug in other tumors is under therapeutic investigation.
  4,201 785 19
Anti-inflammatory activity of calcium channel blocker lercanidipine hydrochloride
Prathap Vasigar, Mounissamy Batmanabane
October-December 2013, 4(4):238-242
DOI:10.4103/0976-500X.119707  PMID:24250199
Objective: To evaluate the anti-inflammatory effect of the third-generation CCB, lercanidipine. Materials and Methods: The ability of lercanidipine to reduce inflammation in carrageenan-induced paw edema in rats was evaluated, using different doses and its anti-inflammatory effect was compared with that of diclofenac sodium. Mast cell degranulation effect of lercanidipine was also carried out. Results: Lercanidipine produced a significant reduction in the inflammatory paw edema at all doses and at all intervals (P < 0.001). The percentage of reduction in edema was found to be proportionate to the doses of lercanidipine. Lercanidipine also significantly reduced the percentage of propranolol-induced mast cell degranulation. Conclusions: It was found that lercanidipine exerts a positive anti-inflammatory effect in a dose-dependent manner and was superior to diclofenac sodium.
  3,551 775 2
Idiopathic intracranial hypertension secondary to ingestion of Morinda coreia and Azadirachta indica leaves extract in infant
Thirunavukkarasu Arun Babu, Shanthi Ananthakrishnan
October-December 2013, 4(4):298-299
DOI:10.4103/0976-500X.119722  PMID:24250212
We report a case of idiopathic intracranial hypertension (IIH) secondary to ingestion of Morinda coreia (Nonan) and Azadirachta indica (Neem) leaves extract in a nine months old child. This herbal extract is believed to accelerate weight gain in infants and is commonly used in South India.
  3,205 339 4
Virtual screening studies reveal linarin as a potential natural inhibitor targeting CDK4 in retinoblastoma
Muthukumaran Sivashanmugam, Chandana Raghunath, Umashankar Vetrivel
October-December 2013, 4(4):256-264
DOI:10.4103/0976-500X.119711  PMID:24250202
Objective: To find out whether linarin can be used as a potential natural inhibitor to target CDK4 in retinoblastoma using virtual screening studies. Materials and Methods: In this study, molecular modeling and protein structure optimization was performed for crystal structure of CDK4 (PDB id: 3G33), and was subjected to Molecular Dynamics (MD) simulation for 10 nanoseconds, as a preparatory process for docking. Furthermore, the stable conformation obtained in the MD simulation was utilized for virtual screening against the library of natural compounds in Indian Plant Anticancer Compounds Database (InPACdb) using AutoDock Vina. Finally, best docked ligands were revalidated individually through semi-flexible docking by AutoDock 4.0. Results: The CDK4 structure was stereochemically optimized to fix clashes and bad angles, which placed 96.4% residues in the core region of Ramachandran plot. The final structure of CDK4 that emerged after MD simulation was proven to be highly stable as per different validation tools. Virtual screening and docking was carried out for CDK4 against optimized ligands from InPACdb through AutoDock Vina. This inferred Linarin (Inpacdb AC.NO. acd0073) as a potential therapeutic agent with binding energy of -8.9 kJ/mol. Furthermore, it was also found to be valid as per AutoDock 4.0 semi-flexible docking procedure, with the binding energy of -8.18 kJ/mol and Ki value of 1.01 μM. Conclusion: The docking results indicate linarin, a flavonoid plant compound, as a potential inhibitor of CDK4 compared to some of the currently practiced anticancer drugs for retinoblastoma. This finding can be extended to experimental validation to assess the in vivo efficacy of the identified compound.
  2,938 525 4
Expression of cFos and brain-derived neurotrophic factor in cortex and hippocampus of ethanol-withdrawn male and female rats
Paul E Alele, Leslie L Devaud
October-December 2013, 4(4):265-274
DOI:10.4103/0976-500X.119712  PMID:24250203
Objective: To map areas of brain activation (cFos) alongside changes in levels of brain-derived neurotrophic factor (BDNF) to provide insights into neuronal mechanisms contributing to previously observed sex differences in behavioral measures of ethanol withdrawal (EW). Materials and Methods: Immunohistochemical analysis of cFos and BDNF levels using protein-specific antibodies and visualization with nickel-enhanced DAB staining in 3 cortical and 4 hippocampal regions was used to assess EW-induced expression of these proteins. Results: EW male and female rats showed significantly higher levels of cFos expression compared to controls in the hippocampal regions whereas EW OVX rats showed higher levels compared to controls only at 1 day EW in the dentate gyrus. Males expressed higher basal levels of cFos in the CA1 subfield of the hippocampus and in the motor cortex than either intact or OVX female rats. BDNF immunoreactivity was also significantly higher in EW rats compared to that in controls, varying with sex and brain region at 1 and 3 days EW. Conclusions: Sex-and brain region-specific changes in expression of cFos and BDNF occurring during 1 and 3-day EW, suggest that differential activation and expression of neurotrophins may influence the observed sex differences and support the suggestion that EW is a chronic stressor, eliciting sequential neuronal activation and neurotrophin regulation.
  2,682 568 5
Evaluation of a new computerized psychometric test battery: Effects of zolpidem and caffeine
Raveendranadh Pilli, MUR Naidu, Usharani Pingali, JC Shobha
October-December 2013, 4(4):247-255
DOI:10.4103/0976-500X.119710  PMID:24250201
Objective: To evaluate the effects of centrally active drugs using a new indigenously developed automated psychometric test system and compare the results with that obtained using pencil- and paper-based techniques. Materials and Methods: The tests were standardized in 24 healthy participants. Reproducibility of the test procedure was evaluated by performing the tests by a single experimenter on two occasions (interday reproducibility). To evaluate the sensitivity of the tests, the effects of zolpidem (5 mg) and caffeine (500 mg) versus placebo were studied in 24 healthy participants in a randomized, double-blind three-way crossover design. Results: Psychometric tests were performed at baseline and at 1, 2, and 3 h after administration of study medication. The effects of zolpidem and caffeine on the psychomotor performance were most pronounced 1 h after administration. At this time, a significant impairment of performance in the simple reaction test (SRT), choice discrimination test (CDT), digit symbol substitution test (DSST), digit vigilance test (DVT), and card sorting test (CST) was observed with zolpidem. In contrast, caffeine showed a significant improvement in performance in CDT and DVT only. Conclusion: The results suggest that the tests of the computerized system are more sensitive and reliable then the pencil and paper tests in detecting the effects of central acting agents and are suitable for use in clinical areas to conduct studies with patients.
  2,822 381 2
Phenytoin induced Stevens-Johnson syndrome exacerbated by cefepime
Varsha A Prabhu, Sahiti Doddapaneni, Girish Thunga, Rajakannan Thiyagu, M Mukyaprana Prabhu, Kushal Naha
October-December 2013, 4(4):291-293
Steven Johnson syndrome (SJS) is a rare drug induced mucocutaneous reaction. Here, we present an elaborate report of a 28-year-old female patient who developed Phenytoin induced SJS, which was exacerbated by cefepime.
  2,758 391 1
Pioglitazone suspension and its aftermath: A wake up call for the Indian drug regulatory authorities
Arif Hashmi
October-December 2013, 4(4):227-229
DOI:10.4103/0976-500X.119705  PMID:24250197
  2,562 456 1
A rare case of ethambutol induced pulmonary eosinophilia
Kaushik Saha, Ankan Bandyopadhyay, Amitabha Sengupta, Debraj Jash
October-December 2013, 4(4):300-302
DOI:10.4103/0976-500X.119724  PMID:24250213
Antitubercular drug (ATD) induced eosinophilic lung disease is a rare phenomenon. It usually occurs due to isoniazid and para amino salicylic acid. A 34-year-male of sputum positive pulmonary tuberculosis, on antitubercular drugs (rifampicin, isoniazid, ethambutol, and pyrazinamide) for last 3 weeks, presented with generalized arthralgia and maculopapular rash for last 2 weeks and shortness of breath for last 1 week. Chest X-ray and High resolution computerized tomographic scan thorax showed bilateral peripheral airspace opacification. Bronchoalveolar lavage revealed 51% eosinophils of total cellularity (1200/cmm) confirming the diagnosis of pulmonary eosinophilia. ATD was stopped for 2 weeks and then reintroduced one by one. Patient again developed similar kind of symptoms with reintroduction of ethambutol. According to criteria for drug induced pulmonary eosinophilia, he was diagnosed as a case of ethambutol induced pulmonary eosinophilia.
  2,633 329 2
Apoptosis amelioration through hypothermic reperfusion in heart transplant
Fadhil G Al-Amran
October-December 2013, 4(4):275-280
DOI:10.4103/0976-500X.119713  PMID:24250204
Objective: To investigate the effects of two different sets of graft temperature during perfusion on myocardial protection in the immediate post transplantation period in rats. Materials and Methods: Rats grouped into: Sham and two study groups, which include two set groups of heterotopic heart transplant perfused at two different temperature set. The studied groups underwent cuff method cervical heterotopic heart transplant. Myocardial cell injury and stress were assessed by measuring: Cardiac troponin-I, score of tissue injury, reactive oxygen species (ROS) and nitrogen, caspase 3 enzyme, and degree of myocardial apoptosis. The low set temperature (18°C) significantly reduced myocardial cell injury compared to 37°C reperfusion temperature. This cytoprotective effect of low temperature reperfusion phase was addressed by significant reduction in ROS and nitrogen and inflammatory cytokines, caspase 3, and myocardial apoptosis. Conclusion : Hypothermic reperfusion phase exerts cytoprotection in heart transplant through down regulation of oxygen, nitrogen reactive species, and inhibition of apoptosis.
  2,546 246 -
Elevation of blood ciclosporin levels by voriconazole leading to leukoencephalopathy
Qu Caihong, Liu Weimin, Zhu Jieming
October-December 2013, 4(4):294-297
DOI:10.4103/0976-500X.119721  PMID:24250211
We report that one 18-year-old female patient with no epilepsia history developed severe epileptiform seizures while she was receiving "ciclosporin A (CsA)-mycophenolate-methylprednisolone" antirejection therapy after combining one week's voriconazole administration following allogeneic hematopoietic stem cell transplantation (allo-HSCT) for myelodysplastic syndromes (MDS). Her blood concentration of CsA was 378 ng/ml (elevated ↑64%, contrasted with the level before the addition of voriconazole) on the second day of admission, and the MRI of head showed leukoencephalopathy in bilateral occipital and left frontal lobe on the 4 th day of admission. The most likely mechanism is that because of voriconazole's enzyme inhibition and CsA as the substrate of hepatic enzymes, voriconazole elevated the blood concentration of CsA and enhanced its toxicity. This case highlights the importance of clinical pharmacists joining the medical team and optimizing the patients' treatment protocols by performing a systematic literature research, accumulating the knowledge of the potential drug interaction and examining prescriptions.
  2,422 361 2
Cardiovascular medications among the critically ill patients of a tertiary care hospital: A drug utilization study
Lisha Jenny John, Padmini Devi, Shoba Guido
October-December 2013, 4(4):285-287
DOI:10.4103/0976-500X.119717  PMID:24250208
  2,279 387 -
Inadequate pain relief for patients with trauma: A cause for concern?
Sadasivam Balakrishnan, Ratinder Jhaj, Vishnu Raj
October-December 2013, 4(4):281-282
DOI:10.4103/0976-500X.119714  PMID:24250205
  2,280 242 -
Paroxetine in the treatment of recurrent brief depressive disorder
Sathya Prakash, Piyali Mandal, Rajesh Sagar
October-December 2013, 4(4):288-290
DOI:10.4103/0976-500X.119718  PMID:24250209
Recurrent brief depressive disorder is now a well-recognized type of depressive disorder. However, there is still no clear evidence base for its treatment. The efficacy of several drugs including antidepressants and mood stabilizers in this disorder has been controversial. Methodological limitations need to be considered when interpreting the results of studies on efficacy of drugs in this disorder. We report a case of recurrent brief depressive disorder that responded dramatically to paroxetine. However, there is a need for larger, methodologically sound, double-blind, placebo-controlled studies.
  2,117 247 -
Does partially integrated learning program help students learn better: A quasi-experimental study in pharmacology
Tirthankar Deb, Abhik Chakrabarti, Ritesh Singh
October-December 2013, 4(4):282-283
DOI:10.4103/0976-500X.119716  PMID:24250206
  2,017 242 -
The pharmacovigilance toolkit
P Ravi Shankar
October-December 2013, 4(4):307-308
  1,798 264 -
Modulation of conditioned avoidance response and quetiapine-induced metabolic syndrome by rosuvastatin and CDP-choline in rats
Ahmad Shafique, KK Pillai, Abdi Sayed Aliul Hasan, AK Najmi
October-December 2013, 4(4):283-285
DOI:10.4103/0976-500X.119715  PMID:24250207
  1,633 333 -
Retraction Notice

October-December 2013, 4(4):308-308
  1,776 190 -