Division 5.2.4 Reports of human pharmaco-dynamic studiesF1
United Kingdom
- a))
The pharmaco-dynamic action correlated to the efficacy shall be demonstrated including:
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the dose-response relationship and its time course,
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justification for the dosage and conditions of administration,
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the mode of action, if possible.
The pharmaco-dynamic action not related to efficacy shall be described.
The demonstration of pharmaco-dynamic effects in human beings shall not in itself be sufficient to justify conclusions regarding any particular potential therapeutic effect.
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- b))
If the medicinal product is normally to be administered concomitantly with other medicinal products, particulars shall be given of joint administration tests performed to demonstrate possible modification of the pharmacological action.
Pharmaco-dynamic interactions between the active substance and other medicinal products or substances shall be investigated.