What Population Pk Analysis Can Be Used for in Drug Development
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چکیده
A population PK approach can be exploited throughout drug development to provide information about potential changes in the dose-exposure relationship for special populations (elderly, paediatrics, renal and hepatic impairment, etc) as an alternative to conducting specific studies. The usefulness of the population PK approach will, however, be highly dependent upon whether the inclusion/ exclusion criteria are sufficiently flexible to allow a sufficient range of a given covariate of interest (e.g. age) to be studied. If insufficient patients are included over the range of the covariate, then specific studies may still be required.
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