Division 5.2.3 Reports of human pharmaco-kinetic studiesF1
United Kingdom
- a))
The following pharmaco-kinetic characteristics shall be described:
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absorption (rate and extent),
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distribution,
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metabolism,
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excretion.
Clinically significant features including the implication of the kinetic data for the dosage regimen especially for patients at risk, and differences between man and animal species used in the pre clinical studies, shall be described.
In addition to standard multiple-sample pharmaco-kinetics studies, population pharmaco-kinetics analyses based on sparse sampling during clinical studies can also address questions about the contributions of intrinsic and extrinsic factors to the variability in the dose- pharmaco-kinetics response relationship. Reports of pharmaco-kinetic and initial tolerability studies in healthy subjects and in patients, reports of pharmaco-kinetic studies to assess effects of intrinsic and extrinsic factors, and reports of population pharmaco-kinetic studies shall be provided.
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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-kinetic interactions between the active substance and other medicinal products or substances shall be investigated.