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1-Systemic Clearance Extended Calculation
A drug has the following pharmacokinetic parameters:
Fraction unbound (fu): 0.5
Clearance by active secretion (CLsec): 5.4L/hr
Fraction reabsorbed (FR): 0.2
Hepatic Extraction Ratio (EH): 0.1

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Calculate the total SYSTEMIC CLEARANCE for this drug showing all working out, and stating all assumptions:

2-Therapeutic Monitoring Essay
A number of factors can contribute to inter- and intra- individual variability in the pharmacokinetics of a drug, and because of this it is sometimes necessary to use

a different dose of the same drug to treat different people.
(a) Identify the circumstances and populations where variability may be most important.
(b) Describe the approaches that may be used to control for this variability. (maximum 250 words total)

3-Intra-Individual Variability Essay
During the pre-clinical development of a new anti-cancer drug it is determined that the drug is requires hepatic activation in order to elicit a therapeutic effect.

Further studies identify CYP2C19 as the sole enzyme involved in the activation of this drug.
Select ONE specific factor (from the categories environmental, genetic or physiological) that may contribute to intra-individual variability in the activation of THIS

drug, and describe the potential consequences of this variability in terms of patient response and tolerability. (maximum 250 words)


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