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Project_online.docx - Project Comparing Methods for...

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Project Comparing Methods for Dissolving Drug Tablets- Dissolution Method Equivalence Testing For: IEGR 351: Probability and Statistics for Engineers - II Dr. B. Kattel Department of Industrial and Systems Engineering Morgan State University Introduction
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The pharmaceutical industry has quality engineers are responsible for maintaining the quality of drug products produced in the manufacturing process. The key to quality is an assessment of product characteristics through repeated measurements of the variable of interest. When the variable is the concentration of a particular constituent in a mixture, the process is called an assay. Two statisticians Russel Reeve and Francis Giesbrecht explored the dissolution characteristics of a new immediate-release drug product manufactured by a well-known pharmaceutical company. An immediate-release product is designed to dissolve and enter the bloodstream as fast as possible. To test for dissolution of the solid-dosage drug, the company uses an apparatus with six vessels or tubes, each tube containing a dissolving solution. Drug tablets or capsules are dropped and analyzed using high performance liquid chromatography (HPLC). The HPLC device quantifies how much of the drug is in the solution; this value is expressed as percent of label strength (%LS). Objective The purpose of this analysis is to focus on a chemical assay to determine how fast a solid-dosage pharmaceutical product (e.g., an aspirin tablet or capsule) dissolves. Since variation in the dissolution of the drug can have harmful effects on the patient, quality inspectors require a test that accurately measures dissolution. Dissolution test data for an analgesic in Tablet form conducted at two manufacturing sites (New Jersey and Puerto Rico) are provided in the following Table. Note that the %LS values were obtained at four different points in time – after 20 minutes, after 40 minutes, after 60 minutes, and after 120 minutes – for each of the six vessels. Site Time (min.) Vessel 1 Vessel 2 Vessel 3 Vessel 4 Vessel 5 Vessel 6 New Jersey 20 5 10 2 7 6 0 40 72 79 81 70 72 73 60 96 99 93 95 96 99 120 99 99 96 100 98 100 Puerto Rico 20 10 12 7 3 5 14 40 65 66 71 70 74 69 60 95 99 98 94 90 92 120 100 102 98 99 97 100 Methods and Procedures
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Based on the sample data provided, to calculate the mean, median, maximum, minimum, standard deviation, variance, first quartile, and third quartile the use of Microsoft Excel and Mini tab makes it easier. The descriptive statistics helps us to know helps us to know the basic features of the values of the data (New Jersey and Puerto Rico sites). It helps to present quantitative descriptions in a manageable form .i.e. to know the wide spread between values in the data. To reach a confident conclusion if the two sites (New Jersey and Puerto Rico sites) will produce equivalent assay results, multiple tests have to be performed. The first test is the test of hypothesis for each time period, which is a method by which an analyst tests a statistical hypothesis. The method used by the analyst depends on the nature of the data used, and the objectives of the analysis. The objective of the analyst is to accept or reject the null hypothesis
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