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Given this situation and the many potential sites for inter- action that exist within the body discount slimex 15 mg amex, it is not surprising that an interaction may occur between them slimex 15mg with visa, whereby either the pharmacokinetics or the pharmacodynamics of one drug is altered by another. More often than not, however, the interaction is of no clinical significance, because the response of most systems within the body is 1 2 Rowland graded, with the intensity of response varying continuously with the concen- tration of the compound producing it. Only when the magnitude of change in response is large enough will an interaction become of clinical significance, which in turn varies with the drug. For a drug with a narrow therapeutic window, only a small change in response may precipitate a clinically significant inter- action, whereas for a drug with a wide margin of safety, large changes in, say, its pharmacokinetics will have no clinical consequence. Also, it is well to keep in mind that some interactions are intentional, being designed for benefit, as often arises in combination therapy. Clearly, those of concern are the unintentional ones, which lead to either ineffective therapy through antagonism or lower concentrations of the affected drug or, more worryingly, excessive toxicity, which sometimes is so severe as to limit the use of the offending drug or, if it produces fatality, result in its removal from the market. This chapter lays down the conceptual framework for understanding the quantitative and temporal aspects of drug-drug interactions, hereafter called drug interactions for simplicity. Emphasis is placed primarily on the pharmacokinetic aspects, partly because pharmacokinetic interactions are the most common cause of undesirable and, to date, unpredictable interactions and also because most of this book is devoted almost exclusively to this aspect and indeed to one of its major components, drug metabolism. Some pharmacodynamic aspects are also covered, however, for there are many similarities between pharmacokinetic and pharmacodynamic interactions at the molecular level and because ultimately one has to place a pharmacokinetic interaction into a pharmacodynamic perspective to appreciate the likely therapeutic impact (1–5). Absorption, which applies to all sites of administration other than direct injection into the bloodstream, comprises all processes between drug administration and appearance in circu- lating blood. Disposition comprises both the distribution of a drug into tissues within the body and its elimination, itself divided into metabolism and excretion of unchanged drug. Disposition is characterized independently following intra- venous administration, when absorption is not involved. Increasingly, aspects of potential drug interactions are being studied in vitro not only with the aim of providing a mechanistic understanding but also with the hope that the findings can be used to predict quantitatively events in vivo, and thereby avoid or limit undesired clinical interactions. To achieve this aim, we need a holistic approach whereby individual processes are nested within a whole body frame—that is, constructs (models) that allow us to explore the impact, for example, of inhibition or induction of a particular metabolic pathway on, say, the concentration–time profile of a drug in the circulating plasma or blood, which delivers the drug to all parts of the Introducing Pharmacokinetic and Pharmacodynamic Concepts 3 Figure 1 Schematic representation of processes comprising the pharmacokinetics of a compound. Absorption comprises all events between drug administration and appearance at the site of measurement. Distribution is the reversible transfer of the drug from and to other parts of the body.

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Most studies standardize these buy slimex 15 mg without prescription, but do not consider their effects purchase 15 mg slimex amex, although when they are considered, confusion may result. Altman’s (1979) criticism of the design of the study by Serfontein and Jaroszewicz (1978) provoked the response that: “For the actual study it was felt that the fact assessments were made by two different observers (one doing only the Robinson technique and the other only the Dubowitz method) would result in greater objectivity” (Serfontein and Jaroszewicz, 1979). What we need is a design and analysis which provide estimates of both error and bias. We feel that a relatively simple pragmatic approach is preferable to more complex analyses, especially when the results must be explained to non-statisticians. It is difficult to produce a method that will be appropriate for all circumstances. What follows is a brief description of the basic strategy that we favour; clearly the various possible complexities which could arise might require a modified approach, involving additional or even alternative analyses. Properties of each method: repeatability The assessment of repeatability is an important aspect of studying alternative methods of measurement. Replicated measurements are, of course, essential for an assessment of repeatability, but to judge from the medical literature the collection of replicated data is rare. Repeatability is assessed for each measurement method separately from replicated measurements on a sample of subjects. We obtain a measure of repeatability from the within- subject standard deviation of the replicates. The British Standards Institution (1979) define a coefficient of repeatability as “the value below which the difference between two single test results... Provided that the differences can be assumed to follow a Normal distribution this coefficient is 2. For the purposes of the present analysis the standard deviation alone can be used as the measure of repeatability. It is important to ensure that the within-subject repeatability is not associated with the size of the measurements, in which case the results of subsequent analyses might be misleading.

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