NOAELThe no observed adverse effect level (NOAEL) is the highest tested dose of a medicine at which there is no increase in the frequency of any adverse effects (biological or statistically significant) when compared to its control.
Although the NOAEL approach involves some consideration of(...)
Non-clinical testingNon-clinical testing is conducted at a stage of medicines development that uses animals and/or cells or tissues. It does not involve testing in humans. The main goal of non-clinical tests is to determine the safety of a medicine. Non-clinical testing will investigate any harmful effects of the(...)
Non-interventional observational studyIn epidemiology and statistics, an observational study draws conclusions about the possible effect of a treatment on participants, where the assignment of participants into a treatment group versus a control group is outside the control of the investigator. In a non-interventional(...)
Non-maleficenceNon-maleficence means to do no harm. Traditionally, this is at the heart of medical ethics and is part of the Hippocratic Oath (an oath that new doctors take in many countries). An example of a non-maleficent action would be stopping a medication known to be harmful or refusing to give a(...)
Non-randomised trialIn a non-randomised clinical trial, participants are allocated to different treatment (or placebo) arms using a non-random method. Allocation is decided and managed by the investigator. Non-random allocation can lead to bias in the results of a trial.In the description above, the(...)
NOMANorwegian National Competent Authority. http://www.legemiddelverket.no"
Null hypothesisThe word ‘null’ can be thought of as ‘no change’. A null hypothesis is typically the standard assumption and is defined as the prediction that there is no interaction between variables.For example, the null hypothesis states that there is no causal relationship between a new treatment and a(...)
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