Test 1 2021 Flashcards
test
list 10 steps needed to construct the uncerainity budeget
1 - Define the the measureand
2 - Describe the model equation
3 - Identify all possible sources of uncertainity
4 - Evaluate all input quantities
5 - Evaluate the standart uncerainity of each input quantities
6 - Calculate the equation of the measurand using the equation model
7 - Calculate the combine standard uncertainity of the result
8 - Calculate the expanded with as select k
9 - Analyse the uncertainity contribtuon index
10- Document all steps in the report
The delivery of a reliable values to the uncertainty of measurement is key to the
understanding all areas of natural sciences.
In the ‘old system’ of ISO and IUPAC, how was the uncertainty of measurements
determined and how was it calculated?
First, the data were subjected to outlier testing, where outliers were detected
by means of Grubb’s test, Dixon’s Q-test, or similar methods of statistics.Next, the average value and standard deviation were calculated, according to
zero-order modelling or first-order modelling
Finally, the confidence range without the outliers was calculated by using the
standard deviation and the number of repetitions
How is the uncertainty of measurement defined in the new system that was
implemented by multiple international organisations of metrology and quality
assurance?
The guidelines of GUM and QUAM outline the process for calculating the uncertainty of measurement. This involves creating an uncertainty budget that lists all steps of unit operations in a Standard Operating Procedure (SOP). Each step contributes a standard uncertainty to the budget. The standard uncertainties, along with an additional term for uncertainty of repetition, are used in the law of propagation of uncertainties to calculate the combined uncertainty. This combined uncertainty is then multiplied by a factor of two to obtain the expanded uncertainty, which represents the uncertainty of measurement.
Explain in your own words, why was it necessary to revise the old system of
metrology and quality assurance?
The removal of outliers is performed differently in different laboratories,
which may give issues with the reproducibility, especially when using a low
number of repetitions. With a low number of repetitions, the rejection of
outliers has a profound influence on the results whereas rejection of outliers
with a large data set has almost no influence on the results.The application of confidence ranges presents a similar problem, but in this
case, the major issues with reproducibility are found after a high number of
repetitions.
The Eurachem/CITAC/BIPM guideline to Quantifying Uncertainty in Analytical
Measurement (QUAM) provides a comprehensive description of the uncertainty
budget and the calculation of uncertainties to methods of analytical chemistry.
Explain the role QUAM plays in the work to perform a method validation
The QUAM guideline is used to prepare the uncertainty budget from the SOP.The QUAM guideline provides reliable values to
the uncertainty of measurement, which is represented by the expanded
uncertainty.
Which graphs, diagrams and tables are needed to fulfil the requirements of
QUAM?
- Table of uncertainty calculations
- Graph with bar plot of uncertainty budget
- A fishbone diagram
How does QUAM recommend treating outliers?
Spurious errors may not always be immediately apparent. When enough replicate measurements are taken, it’s advisable to conduct an outlier test to identify potentially problematic data points within the dataset. However, any positive result from such a test should be approached with caution. If possible, the results should be verified by the original source. It’s generally not advisable to discard a data point solely based on statistical grounds.
Suppose that you synthesized a new chemical compound that showed good
antibacterial activity and it might be used to treat infections in humans.
Give the designation of the chemical compound that is key to the efficacy of the
treatment.
Active pharmaceutical ingredient (API).
Describe all the steps that are needed be undertaken, in order to take the product
from laboratory to the market
Preclinical Research (Microorganisms and Animals): This phase involves laboratory and animal studies to assess the safety and efficacy of the product. It aims to gather preliminary data on the product’s potential effects and identify any potential risks.
Phase 1 Clinical Trials (Humans): In this phase, the product is tested on a small group of healthy volunteers to evaluate its safety, dosage range, and potential side effects. The main goal is to determine the product’s safety profile and establish a safe starting dose for further studies.
Phase 2 Clinical Trials (Humans): This phase involves testing the product on a larger group of individuals who have the condition or disease the product is intended to treat. These trials further evaluate the product’s safety and efficacy, as well as its optimal dosage and potential side effects.
Phase 3 Clinical Trials (Humans): In this phase, the product is tested on an even larger group of participants to confirm its effectiveness, monitor side effects, and compare it to existing treatments or a placebo. The data collected in this phase are crucial for regulatory approval and determining the product’s overall benefit-risk profile.
THrese is phase IV please read about it
