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level: Data And Introductory Stats

Questions and Answers List

level questions: Data And Introductory Stats

Question	Answer
a collection of standards for medicinal products and pharmaceutical substances	Pharmacopoeia
any substance or combination of substances presented as having properties for treating or preventing disease in human beings and/or animals	Medical Product
Any substance intended to be used in the manufacture of a medical product and that, when so used, becomes an active ingredient of the medical product.	Active Ingredient (AI) or Active Pharmaceutical Ingredient (API)
Any constituent of a medicinal product that is not an active substance	Excipient
Stabilisers, preservatives, sweeteners,pH regulators	Example of an excipient
– Paracetamol (AI), – Hydroxypropyl cellulose (binder), – Maize starch (disintegrant), – Talcum (Glident) and – Magnesium stearate (lubricant).	What does Paracetamol tablet contain?
Diagram	The life of medicines
When satisfied that a product works it is given marketing authorisation or product license	Marketing authorisation
To ensure only authorised manufacturers manufacture licensed products	Manufacturing authorisation
- Quality Management System (QMS) – Good Manufacturing Practice (GMP) and – Quality Assurance (QA) – Quality Control (QC)	The attainment of quality is the responsibility of management and relies on what?
The planned and systematic activities necessary to provide adequate confidence that the product or service will meet the given requirements	Quality Assurance
The operational techniques and individual activities that focus on controlling or regulating processes and materials to fulfill requirements for quality. The focus is on preventing defective products or services from being passed on.	Quality Control
QA is process orientated and QC is product orientated	Whats the difference between QA and QC
QA - makes sure you are doing the right things, in the right way (Proactive) QC - makes sure the results of what you've done are what you expected (Reactive)	Layman's Terms
They define how to carry out protocol specified activities. Most often they are written in a chronological listing of action steps.	Standard Operating Procedures
Can be detected and corrected Affect all results in an analytical series in the same direction	Systematic errors
Cannot be detected Random in nature	Random Errors
the quality of being near to the true value	Accuracy
the quality of being reproducible in amount or performance - variance, SD	Precision
X-Xt	Absolute Error
(X-Xt/Xt) x 100%	Relative Error
the selection of a random sample; each element of the population has an equal chance of being selected	Random Sampling
division of population into subsets and then random sampled e.g split population into men and women then randomly sample from men and randomly sample for women	stratified random sampling
Sampling at given intervals	Systematic sampling
Divide population into sections (Clusters) randomly select a few of the sections, choosing all members from them	Cluster sampling
Using data that is readily available	Convenience sampling
.	Variance Equation
the square root of the variance	Standard Deviation
(standard deviation/mean) x 100%	Relative Standard Deviation
an interval with a given probability that the true value lies within - degrees of freedom = n-1 t = taken from table u = true value	Confidence Intervals
degrees of freedom = n1 + n2 - 2 If t-calculated > table value = significantly different	t test
Q-calculated > table value = reject outlier	Q test