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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

Question:
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.
Question:
(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.
Question:
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)