A guide for reporting the results of population pharmacokinetic analyses: A Swedish perspective
Journal Title: The AAPS Journal - Year 2005, Vol 7, Issue 2
Abstract
Population pharmacokinetic analyses are frequently part of regulatory submissions and are mainly used to provide information on special populations (effects of age, renal impairment, etc) and drug-drug interactions. A varying standard of population analysis reports has been received at the Medical Products Agency in Sweden, some very good and some unassessable. In the latter case, it may be that it is a report of an inadequate analysis or may be a report of a perfectly acceptable analysis, but too little detail has been provided in the report for the conclusions reached to be properly assessed. A sufficient level of detail must be present in these reports in order for them to be assessable and to allow the conclusions reached to be incorporated into the summary of product characteristics. The report should specify the goal(s) of the analysis, describe in detail the origin and nature of the data, clearly describe the model-building process, include a range of goodness of fit (GOF) plots to support decisions made during the model-building process, and demonstrate that the final model is a good description of the data. The use of color in GOF plots is encouraged so that key features are easily visible. Covariate effects in the final model should be clearly presented and their clinical relevance discussed. In the case of many covariates in the final model, it may be useful to perform some simulations to illustrate the effect of various covariate combinations for a series of different “typical” subjects.
Authors and Affiliations
Janet R. Wade, Monica Edholm, Tomas Salmonson
Keywords
Related Articles
- EP ID EP681878
- DOI 10.1208/aapsj070245
- Views 67
- Downloads 0
Optimization of chlorphenesin emulgel formulation
This study was conducted to develop an emulgel formulation of chlorphenesin (CHL) using 2 types of gelling agents: hydroxypropylmethyl cellulose (HPMC) and Carbopol 934. The influence of the type of the gelling agent and...
Serotonin transporters: Implications for antidepressant drug development
Due to the complexity of the disease, several hypotheses exist to explain the etiology of depression. The monoamine theory of depression suggests that disruptions in the serotonergic and noradrenergic systems result in d...
Allometric scaling of xenobiotic clearance: Uncertainty versus universality
Statistical analysis and Monte Carlo simulation were used to characterize uncertainty in the allometric exponent (b) of xenobiotic clearance (CL). CL values for 115 xenobiotics were from published studies in which at lea...
Drug Repurposing: Far Beyond New Targets for Old Drugs
Repurposing drugs requires finding novel therapeutic indications compared to the ones for which they were already approved. This is an increasingly utilized strategy for finding novel medicines, one that capitalizes on p...
Does the Recent Growth of Aquaculture Create Antibiotic Resistance Threats Different from those Associated with Land Animal Production in Agriculture?
The online version of this article (doi:10.1208/s12248-015-9722-z) contains supplementary material, which is available to authorized users.