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BPS3082 Applied pharmacokinetics, dynamics and product development S2 2025

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•IDR III – Berkeley Madonna code IDR3.txt

•Single bolus dose, one compartment PK

•Indirect response model III describing stimulation of input, with baseline, i.e. the response R is at 10 without any drug

•Simulate (in overlay mode) R over time for escalating doses, e.g. between 10 mg and 10,000 mg and observe what happens with the shapes of the profiles as the dose increases

•Upload an image of the PK/PD profiles (response R over time, i.e. the PK/PD profiles) onto Moodle

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•Biophase model – Berkeley Madonna code Biophase.txt

•Single bolus dose, one compartment PK

•Biophase model describing delay due to distribution of drug to site of action (biophase, hypothetical effect compartment), with baseline, i.e. the effect is at 1 without any drug

•Simulate (in overlay mode) Effect over time for escalating doses, e.g. between 10 mg and 2,000 mg and observe what happens with the shapes of the profiles as the dose increases

•Upload an image of the PK/PD profiles (Effect over time, i.e. the PK/PD profiles) onto Moodle

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Biophase or Indirect response (IDR) model? Which one would you choose for each of the following and why?

Effect of propofol on general anaesthesia

Effect of alendronate on biomarkers that describe bone turnover

Effect of γ-Secretase modulators on pathogenic amyloid-β peptide production in Alzheimer’s disease

Effect of sodium glucose cotransporter 2 inhibitors (SGLT2i) on fasting plasma glucose

Effect of morphine on the EEG in a rat study

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A certain drug has an elimination half-life of 1 h. The duration of effect following a 100 mg dose is 6 h. How long will be the duration of effect for a 200 mg dose?

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Your company has performed a PK study in mice (weight 25 g) with the new antibiotic. Protein binding is 99%. For successful inhibition of bacterial growth of P. aeruginosa, 25% of the max. effect are required.

5. What is the expected duration of effect of a 1 mg/kg IV bolus of your drug in the mouse against a bloodstream infection caused by P. aeruginosa?

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Your company has performed a PK study in mice (weight 25 g) with the new antibiotic. Plasma protein binding is 99%.

4. What is the %max. effect of a 0.1 mg/kg dose of your drug at the C_max in the mouse against a bloodstream infection caused by K. pneumoniae?

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Your company has performed a PK study in mice (weight 25 g) with the new antibiotic. Plasma protein binding is 99%.

3. What is the %max. effect of a 1 mg/kg IV bolus of your drug at the C_max in the mouse against a bloodstream infection caused by P. aeruginosa?

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Your company is performing a pharmacodynamic study with a new antibiotic. The effect of the antibiotic is studied in vitro against different bacteria, P. aeruginosa and K. pneumoniae.

2. What is the %max. effect of 60 ng/mL of your drug vs K. pneumoniae?

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Your company is performing a pharmacodynamic study with a new antibiotic. The effect of the antibiotic is studied in vitro against different bacteria, Pseudomonas aeruginosa and Klebsiella pneumoniae.

1. What is the %max. effect of 60 ng/mL of your drug vs P. aeruginosa?

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Do you think that in general the maximal effect intensity (100%) can be reached in a person, and why or why not?

Yes, it can be reached, but the tablet might become too large to swallow.

Yes it can be reached, only need to increase the dose enough.

No it cannot be reached, even if we increased the dose by a lot.

A and C

B and D

No it cannot be reached, because of likely toxicity at high concentrations.

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