Dose Reconstruction: The Use of Dose Reconstruction in the Determination of Human Exposure

Abstract

Abstract Dose reconstruction is a scientifically acceptable means to perform a retrograde or retrospective analysis of the preceding dose or for numerous exposures of an individual. It is used in a wide range of scientific applications, especially when contemporaneous or near contemporaneous exposure measurements from the time of interest or consideration are undefined. Dose reconstruction is used to attempt to consider numerous individual exposures. It accommodates for fluctuations in the intensity of the exposures and totaling the exposures into an estimated dose over a definitive time period or duration. This paper reviews a method to perform dose reconstruction when limited information is provided concerning the relevant exposure parameters. This methodology is not intended to replace the use of other dose reconstruction models that are available when definitive exposure parameter values are available. We show through the scientific literature and several examples using maximal or near maximal parameter values in calculating the dose that “dose reconstruction” is a valid method to determine retrospective exposure assessments. These retrospective exposure assessments may be used for the purposes of determining the maximal risk or a safety assessment, risk comparison, or toxicological relatedness or risk. The application of such a methodology is at times challenging in the authors’ work due to the limitations in the facts that are provided to them which describe the exposure parameters of an individual. These methods to perform the dose reconstructions are based on sound scientific foundation and are extremely versatile models which can be used in a variety of situations.