@article {121, title = {Design of Drug Dosage Regimen for Valproate: Exploring Modeling and Simulation Based Approach}, journal = {International Journal of Pharmacology and Clinical Sciences}, volume = {3}, year = {2014}, month = {June 2014}, pages = {22-27}, type = {Research Article}, chapter = {22}, abstract = {

Background: Population pharmacokinetic studies attempt to explain the variability in pharmacokinetics among study subjects and explore the role of covariates on the pharmacokinetics. The present study was planned to evaluate by simulation, the various dosage regimens of valproate and their predicted relevance to achieve desired therapeutic ranges and to see the effect of various covariates. Materials and Methods: This study utilized the previous database of therapeutic drug monitoring data of valproate available in the department and population pharmacokinetic models developed by a group in the department. From the database, 93 patients{\textquoteright} details have been used in this study. The simulation studies were carried out for various dosage regimens such as 400mgQ12Hr, 500mgQ12Hr, 800mgQ12Hr, 1000mgQ24Hr for 100 simulated patients using NON-MEM software package. Results: 500mg BID dosage regimen was found to be more advantageous as more number of simulated patients were having the Css within the therapeutic range and the effect of covariates like sex and concomitant phenytoin use were found to be insignificant but with 1000mg OD regimen in females, the number of individuals with Css within the therapeutic range were found to be less with which we could say that the induction effect of phenytoin on valproate metabolism in females could be more than that of males. Conclusion: The present study was able to predict steady state concentrations for various dosage regimen scenarios with possible pharmacokinetic and therapeutic outcomes. This study underscores the relevance of population pharma-cokinetic based simulations in dosage regimen design.

}, keywords = {Dosage regimen, NONMEM, Population pharmacokinetics, Simulations, Valproate}, author = {Shiv sagar K and Nithya Duggirala and Chintan Y Patel and Leelavathy D Acharya and Surulivelrajan Mallayasamy} } @article {182, title = {Management and Treatment Outcome of Complications of Chronic Kidney Disease Patients in a South Indian Tertiary Care Hospital}, journal = {International Journal of Pharmacology and Clinical Sciences}, volume = {2}, year = {2013}, month = {December 2013}, pages = {113-120}, type = {Research Article}, chapter = {113}, abstract = {

Background: Chronic diseases are emerging as one of the leading cause of death nowadays. Among them, the prev-alence of chronic kidney disease (CKD) is increasing because of the increased incidence of diabetes and hypertension which are the main cause of CKD. The rate of progression of CKD to end stage renal disease (ESRD) can be reduced by the early detection and management of risk factors and complications associated with it. The present study aims to study the complications, treatment pattern and associated outcome in hospitalized CKD patients. Materials and Methods: A prospective observational study was conducted from October 2012 to March 2013 in the nephrology unit of Kasturba hospital, Manipal. Adult patients (\> 18 years old) who were diagnosed with CKD were included. Patient demographics, clinical, pharmacological management and laboratory data were collected in a spe-cially designed form for this study purpose. Demography of the patients, complications and medications used for the management etc. were documented and evaluated using SPSS version 16.0. Results: 312 CKD patients were included in the study.. Maximum number of patients was in the age group of 46-60 years and study showed male predominance (77.6\%). Anemia was the most observed complication in the study popu-lation ( 81.7 \%). Monotherapy or combinations of drugs like nebulisation albuterol, insulin with glucose and sodium polystyrene sulfonate was used for the management of hyperkalemia. Anemia is managed by oral and parenteral iron products, erythropoietin and by blood transfusions. Average length of hospital stay was found to be 7.34 {\textpm} 4.89 days. Serum creatinine, creatinine clearance rate, serum urea, serum sodium and serum potassium had improved signifi-cantly (p \< 0.001) from the base line. Total serum calcium was also improved after treatment. Conclusion: Present study highlights the complications, treatment pattern and outcomes in CKD patients from a tertiary care hospital in South India which may help in targeting the major causes of CKD and treatment pattern for the renal failure population. Early identification of patients who are at risk and strategies to decrease the rate of progres-sion of CKD will help to reduce the prevalence and mortality associated with CKD in future.

}, keywords = {Chronic Kidney Disease, Complications, Mortality, Outcome, Treatment pattern}, author = {Sumy George and Leelavathi D Acharya and Ravindra Prabhu A and Surulivelrajan Mallayasamy} }