![]() ![]() Refer below calculation formula for more details. During ‘crush method’ technique, analyst have to use average weight during assay calculation. In case of ‘crush method’, analyst have to take suitable number of tablets, crush them to fine powder and then weigh equivalent amount of crushed powder to prepare test solution. Note: All available digits of the analytical determination of LOD/Water content must be preserved when calculating the assay result.Īverage weight: The test preparation for assay of finished product such as tablets is either done by ‘crush method’ or by ‘drop method’. (anhydrous basis) Standard response Test Conc. Below formula is used for the calculation. The LOD or water content is used to convert ‘as such assay’ to dried or anhydrous basis. ![]() LOD/Water content value: The %assay of drug substance is more often reported on either dried basis or anhydrous basis. The calculation formula used for % assay calculation in case of external standard method is as below If the reference standard is used and if container label does not specify potency value- then use 100% as the potency. The potency on ‘dried basis’ must be used in case if standard is dried before use. ![]() The potency of standard ‘on as such’ or ‘as is basis’ must be considered in case if standard is not dried before use. The potency of the standard needs to be considered during calculation. Standard potency: The standard solution is used for calculation of assay, residual solvents and impurities. In today’s article I am going to walk you through few familiar equations used in laboratory along with precautions to be taken while selecting values of few common factors. Managers must clear doubts about calculations and shall teach analyst how to think logically about different factors used during calculation. Under the guidance of manager, analyst takes utmost care during each and every step but more often lose focus during calculation. While working in a laboratory, analysts come across various activities ranging from analysis, reporting and calculation. To calculate the post-hoc statistical power of an existing trial, please visit the post-hoc power analysis calculator.Being a manager, you must be vigilant. Most medical literature uses a beta cut-off of 20% (0.2) - indicating a 20% chance that a significant difference is missed. Beta is directly related to study power (Power = 1 - β). Beta: The probability of a type-II error - not detecting a difference when one actually exists.Most medical literature uses an alpha cut-off of 5% (0.05) - indicating a 5% chance that a significant difference is actually due to chance and is not a true difference. Alpha: The probability of a type-I error - finding a difference when a difference does not exist.Treatment Effect Size: If the difference between two treatments is small, more patients will be required to detect a difference.Population Variance: The higher the variance (standard deviation), the more patients are needed to demonstrate a difference.Baseline Incidence: If an outcome occurs infrequently, many more patients are needed in order to detect a difference.Generally speaking, statistical power is determined by the following variables: Enrolling too many patients can be unnecessarily costly or time-consuming. ![]() By enrolling too few subjects, a study may not have enough statistical power to detect a difference (type II error). 1īefore a study is conducted, investigators need to determine how many subjects should be included. This calculator uses a number of different equations to determine the minimum number of subjects that need to be enrolled in a study in order to have sufficient statistical power to detect a treatment effect. ![]()
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