EVALUATION OF COVARIATES INFLUENCE ON EUPRESSYL PHARMACOKINETICS USING LINEAR REGRESSION MODEL
Journal Title: International Research Journal of Pharmacy (IRJP) - Year 2014, Vol 5, Issue 9
Abstract
The identification and quantification of covariates, particularly using population pharmacokinetics is now seen as an integral part of drug development. This present study was aimed to assess the influence of subject specific parameters (covariates) on pharmacokinetics of Eupressyl (Urapidil) from typical pharmacokinetics studies. The influence of covariates (age, height, body weight, body mass index) on the pharmacokinetics of Urapidil was evaluated analyzing the data pooled from three different pharmacokinetic studies. The influence of covariates on Urapidil pharmacokinetics was evaluated using linear mixed effect model. Covariate analysis was carried out following a two-stage approach. Results from the first stage analyses showed that there is no significant effect (P > 0.05) on Urapidil pharmacokinetic parameters against evaluated covariates. However, at second stage following linear mixed effect models, subject specific parameters were correlated with obtained pharmacokinetic parameters. The results evidencing that the reasonable influence of covariates on Urapidil pharmacokinetics parameters were observed for different lot of innovator products. Thus, characterizing effect of few of the covariates on pharmacokinetics outcome will definitely reduce the number of pharmacokinetic studies using healthy human subjects and also development time and cost in generic drug developments. However, further pharmacokinetic models for Urapidil to be developed and validated using non-linear mixed effectmodels, as it is considered one of the standard method for evaluating drug variability.
Authors and Affiliations
M. Sundara Nainar, K. Ravisekhar, D. Prabakaran, V. Saji, T. Vijay, R. Sikandar Khan, S. Ashish, Praveen Kumar
Keywords
Related Articles
- EP ID EP99943
- DOI 10.7897/2230-8407.0509149
- Views 110
- Downloads 0
GASTRO PROTECTIVE EFFECTS OF FICUS DALHOUSIAE MIQ ROOTS ETHANOLIC EXTRACT IN INDOMETHACIN AND COLD RESTRAINT STRESS INDUCED ULCERS
The aim of the present study was to evaluate the gastro protective effects of FDREE in Indomethacin and cold restraint stress induced ulcer models. Wistar albino rats were employed in the study. The preliminary phytochem...
ANTIOXIDANT ACTIVITY OF POLYGALA ROSMARINIFOLIA WIGHT& ARN WHOLE PLANT IN ALLOXAN INDUCED DIABETIC RATS
Administration of ethanol extract of Polygala rosmarinifolia whole plant (100 mg/kg and 200 mg/kg body weight) to alloxan induced diabetic rats for 14 days reduced the elevated level of lipid peroxidation (LPO). The trea...
SEASONAL VARIANCE ON GROUNDNUT SEED PRODUCTION: ROUND THE YEAR EXPERIENCES
The peanut, or groundnut (Arachis hypogaea), is a species in the legume or "bean" family (Fabaceae). The peanut was probably first domesticated and cultivated in the valleys of Paraguay. The specific name, hypogaea means...
XIMELAGATRAN: A NEW DIRECT THROMBIN INHIBITOR
Venous thromboembolism is a serious illness that affects patient morbidity and mortality and presents a significant management challenge to healthcare providers world-wide. Despite major achievements in the significant r...
DEVELOPMENT AND VALIDATION OF SIMULTANEOUS EQUATION METHOD FOR SIMULTANEOUS ESTIMATION OF TELMISARTAN AND NIFEDIPINE IN SYNTHETIC MIXTURE
This method deals with the simultaneous determination of the Telmisartan and Nifedipine in the synthetic mixture. This method is simple, precise, accurate and economical. The work was carried out on Shimadzu model 1800 (...