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BPS3082 Applied pharmacokinetics, dynamics and product development S2 2025

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3. Do you think the PK/PD profile might be different for patients with pneumonia or bone infections compared to those with bacteraemia? Why or why not?
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2. Is there any change to the dosage regimen/s that you could recommend if one or both patient group/s are not likely to achieve a favourable response?
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1. Compare the profiles and note down your observations on the comparison. Which group/s of patients is/are likely to achieve/not achieve a favourable response?
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3. If all drug candidates were to progress in clinical development, do you think that some (or one) might have to be dosed more often than others?
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4. Which compound might be preferred, assuming all other factors are the same?
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2. Describe how the differences in EC50 affect the PK/PD profile. Also consider how how the EC50 compares to the Cmax for each of the compounds.
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1. Describe how the differences in EC50 affect the PD profile, including the concentrations required to achieve 50% and 90% of maximum effect.
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Which effect intensity will be achieved by doubling that concentration (i.e. by using a concentration equivalent to 2x EC50)?

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Which concentration is required to achieve 50% of the maximal effect intensity?

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Which option would you select to compare treatments?

Option 1: “This database is a big mess, let’s just analyze for treated vs. non-treated.”

Option 2: “Marketing is only interested in 400 mg, since 800 mg is too toxic. Let’s do four t-tests, ‘is dose X signifi-cantly different from placebo.”

Option 3: “Why don’t we apply ANOVA to use all data simultaneously for the comparison between doses and placebo.”

Option 4: “Maybe we should treat dose as a continuous variable and plot it vs. effect.”

Option 5: “Some people like to plot AUC vs. dose. Does it really make a difference to plot AUC?”

Option 6: A different form of analysis?

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