Predictive performance of the Bayesian analysis: Effects of blood sampling time, population parameters, and pharmacostatistical model

Yano, Ikuko; Kawakatsu, Kazuo; Nishimura, Koichi; Yasuhara, Masato; Hori, Ryohei

doi:10.1007/bf02353410

Cited by 18 publications

(12 citation statements)

References 16 publications

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“…20) When a prediction method such as the Bayesian method is applied, it is important to know the predictability of the drug concentration and individual pharmacokinetic parameters because the predictability depends on the PPK parameters and also on the sampling time. [21][22][23] We have already evaluated the predictive performance of PPK parameters of VCM based on a two-compartment model in Japanese adult patients. 24) The pharmacokinetic variability of VCM in pediatric patients, especially neonates and premature neonates, is generally large because of the changes in body water volume and diŠerences in the extent of renal function maturation.…”

Section: Introductionmentioning

confidence: 99%

Evaluation of Bayesian Predictability of Vancomycin Concentration Using Population Pharmacokinetic Parameters in Pediatric Patients

Ohnishi

Yano

Ishibashi

et al. 2005

Drug Metabolism and Pharmacokinetics

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The objective of this study was to evaluate the Bayesian predictability of vancomycin (VCM) pharmacokinetics in Japanese pediatric patients using one-compartment population pharmacokinetic (PPK) parameters, which we reported previously. The validity of the PPK model was evaluated by bootstrap method and cross validation method, and the Bayesian predictive performance was examined. The predictive performance of the PPK model for premature patients was also examined. The cross validation method showed the predictability to be acceptable for practical use, especially for predicting trough concentration using other trough data. However, for the external premature patient data, this PPK model did not seem to be adequate. A theoretical approach using a simulation technique was also examined to evaluate the predictive performance. The results suggested that the predictability at the peak was not necessarily good at all sampling times and the predictability at the trough was better when a later time point was used. The optimal sampling time for prediction of VCM concentration in pediatric patients is discussed.

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Section: Introductionmentioning

confidence: 99%

Evaluation of Bayesian Predictability of Vancomycin Concentration Using Population Pharmacokinetic Parameters in Pediatric Patients

Ohnishi

Yano

Ishibashi

et al. 2005

Drug Metabolism and Pharmacokinetics

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“…3, 19) ( 3) where Var(Ĉ ) is a variance of prediction error, f is a function of a corresponding PK model (i.e. a two-compartment infusion model), P k is the kth pharmacokinetic parameter (population mean), and m is the number of parameters.…”

Section: Evaluation Of Predicted Performancementioning

confidence: 99%

“…Var(P k ) is the variance of the kth parameter estimate approximately given by Eq. 4 19) : (4) where w 2 and s 2 are the population variances for inter-and intra-individual variations, respectively, and n is the number of observed data items used for a Bayesian prediction. The square root of Eq.…”

Section: Evaluation Of Predicted Performancementioning

confidence: 99%

“…The predictability of a Bayesian method depends on the number of compartments 18) and also it depends on PPK parameters values and the sampling time. [19][20][21] As no precise evaluation of the PPK parameters of Japanese adult patients 15) from the viewpoint of its predictive performance has been performed, we evaluated the predictive performance of a Bayesian method using the PPK parameter setting for patients with various degrees of renal function. The effect of sampling time of the data used for a Bayesian method on the predictability of VCM concentration was also examined.…”

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confidence: 99%

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Evaluation of Bayesian Predictability of Vancomycin Concentration in Patients with Various Degrees of Renal Function.

Ohnishi

Yano

Shimamura

et al. 2001

Biological & Pharmaceutical Bulletin

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To assess the usefulness of the population pharmacokinetic parameters of vancomycin (VCM) based on a two-compartment model in Japanese adult patients, predictability by a Bayesian method was evaluated using a concentration time course after single dosing to 22 patients with various degrees of renal function. Using one or two points from the observed data for each patient, the concentrations predicted by a Bayesian method were compared with the observed data for each sampling time. The patients were separated into five groups based on their renal functions indicated by creatinine clearance, and the mean prediction error (MPE) and root mean squared error (RMSE) were calculated for each group as measures of accuracy and precision, respectively. In both one-and two-point methods, the absolute MPE values at each sampling time in the elimination phase were less than 2.5 m mg/ml, and the RMSE values were also small. No clear differences were found in MPE and RMSE among the groups. In the distribution phase, the MPE and RMSE were somewhat greater, and RMSE in some groups was around 15 m mg/ml when trough data was used to predict the peak concentration. Also, the theoretical RMSE using this population parameter setting could well explain the observed RMSE. These results confirmed this population parameter setting is useful for at least predicting concentration in the elimination phase after single dosing, and the predictability was independent of renal function.

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“…To obviate the need for multiple blood sampling, a population approach can be used. This method is particularly suited to modeling pharmacokinetic responses in a relatively large group of subjects in which there are only limited observations, essentially very sparse data obtained during routine therapeutic drug monitoring (TDM) (11)(12)(13) NONMEM allows the estimation of population average values of pharmacokinetic parameters, such as volume of distribution (V) and clearance (CL) together with estimates of the interindividual variability in the pharmacokinetic parameters, which can be related to the modifying influence of demographic and clinical factors (covariates).…”

Section: Introductionmentioning

confidence: 99%

Population Pharmacokinetics of Carbamazepine in Indian Epileptic Patients

Perumandla

Shesham

Devarakonda

2005

Clinical Research and Regulatory Affairs

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ⅪThe aim of this study was to describe the population pharmacokinetics of carbamazepine in Indian epileptic patient population. The covariates evaluated were total body weight, height, age, dose, and gender. A total of 307 steady state serum concentrations were collected from 84 patients and analyzed. Population pharmacokinetic parameters were calculated using NONMEM, with one compartment first order absorption and elimination. The absorption rate was set at a fixed value of 1.2 h -1 . Exponential interindividual error and additive residual error model were developed. The model that was found to best describe the data following FO method was: Apparent Clearance (CL/F) (L/h)= 0.785 + 1.16 * (TBW/41.2) ** 0.75 * EXP (0.0976); Apparent Volume (V/F) (L) = 24.8 + 21.4 *(TBW/41.2)* EXP (0.740). Similarly the model found to best describe the data following FOCE method was CL/F (L/h) = 0.632 + 1.63 * (TBW/41.2) ** 0.75 * EXP (2.35E-12); V/F (L) = 31.8 + 56.9 *(TBW/41.2)* EXP (0.180).The final model estimates of CL/F and V/F estimated by FO method were 0.05 L/h/kg and 1.7 L/kg respectively and by FOCE method are 0.043 L/h/kg 1.43L/kg respectively. The typical body weight used for this population was 40 kg.

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Predictive performance of the Bayesian analysis: Effects of blood sampling time, population parameters, and pharmacostatistical model

Cited by 18 publications

References 16 publications

Evaluation of Bayesian Predictability of Vancomycin Concentration Using Population Pharmacokinetic Parameters in Pediatric Patients

Evaluation of Bayesian Predictability of Vancomycin Concentration Using Population Pharmacokinetic Parameters in Pediatric Patients

Evaluation of Bayesian Predictability of Vancomycin Concentration in Patients with Various Degrees of Renal Function.

Population Pharmacokinetics of Carbamazepine in Indian Epileptic Patients

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