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The blood plasma used to make the drug was labelled "Not to be administered to humans or used in any drug products".
The dosages administered to rats were 100 to 1,000 times more than the proposed mass dose to be administered to humans.
Preclinical development encompasses all of the activities that must take place before a new chemical entity can be administered to humans.
It can be administered to humans via intramuscular injection with or without electroporation.
A superantigen vaccine will be administered to humans for the first time.
An Investigational New Drug application must be submitted and authorized by FDA before an investigational or biological product can be administered to humans.
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For the purpose of this study, pharmacological interventions were defined as those classified as medicinal products under the EU Directive 2001/83/EEC, i.e. any substance or combination of substances which may be administered to human beings with a view to making a diagnosis or to restoring, correcting or modifying physiological function in human beings.
The novelty of the current study is based on the fact that these therapies were introduced at the peak of the clinical phase of arthritis to more closely model the clinical scenarios where they might be administered to human patients, in contrast to previous publications where treatments were already started at the onset of arthritis.
To achieve success, major efforts in probe development and instrumentation is still required to overcome several technical challenges such as the potential toxicity of imaging probes or contrast agents given the larger quantities that must be administered to human patients, the ability to discriminate true cerebral signal from extracerebral contamination, and the degree of tissue penetrance.
The 300 μg dose of CpG ODN used in the present study is 30-fold higher than the highest dose that has been administered to humans during clinical trials.
It sounds far away, but Dr Lindsay Wu who worked on the UNSW study told VICE that drugs like this being administered to humans and taking on ageing is something we should "expect within our lifetimes".
More suggestions(15)
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