Pharmacology & Medication Management Flashcards
7 cards from real CPI practice questions. Tap to flip, then mark Knew It or Still Learning — missed cards come back until you master them.
Read the first 7 Pharmacology & Medication Management flashcards as text
A participant taking a study SSRI develops hyperthermia, clonus, agitation, and diaphoresis after self-medicating with tramadol. What is the most likely diagnosis?
Answer: Serotonin syndrome
Tramadol inhibits serotonin reuptake; combined with an SSRI, excess serotonergic activity causes serotonin syndrome characterized by the triad of mental status changes, autonomic instability, and neuromuscular abnormalities.
A Phase II dose-ranging trial uses an adaptive design to modify doses based on interim safety data. Which regulatory principle must be maintained to preserve trial integrity?
Answer: Pre-specified adaptation rules and maintenance of blinding
Adaptive designs must have pre-specified decision rules in the protocol; unplanned adaptations or unblinding of the sponsor team inflate type I error and compromise regulatory acceptability.
A clinical trial medication requires reconstitution by the pharmacist. The investigator notes the reconstituted solution has a different color than described in the protocol. What is the correct action?
Answer: Quarantine the medication, document the discrepancy, and contact the sponsor before use
Deviations from expected investigational product appearance require quarantine and sponsor notification per GCP, as this may indicate product degradation, contamination, or compounding error.
A pharmacokinetic study measures drug concentrations at multiple time points. The AUC0-∞ is 1200 ng·h/mL and the AUC0-t is 1100 ng·h/mL. What does the residual AUC (100 ng·h/mL) represent?
Answer: Drug exposure extrapolated beyond the last measured time point to infinity
AUC0-∞ minus AUC0-t represents the extrapolated area from the last sampling time to infinity, estimated from the terminal elimination rate constant.
An investigational drug shows non-linear (saturable) pharmacokinetics at therapeutic doses. What is the most important clinical implication for the trial?
Answer: Small dose increases may cause disproportionately large increases in drug exposure
Saturable (Michaelis-Menten) kinetics cause non-proportional AUC increases with dose escalation, meaning small dose increments can lead to marked toxicity in dose-finding studies.
During a trial, a participant is found to have taken a prohibited concomitant medication (a CYP3A4 inducer) for 2 weeks. The study drug is a CYP3A4 substrate. What is the most likely effect on efficacy assessments?
Answer: Reduced study drug exposure leading to potential underestimation of efficacy
CYP3A4 induction accelerates metabolism of CYP3A4 substrates, lowering their AUC and potentially causing falsely negative efficacy results.
A researcher is evaluating drug abuse potential for a CNS stimulant in a Phase I trial. Which endpoint is considered the regulatory gold standard for assessing subjective drug liking?
Answer: Visual Analog Scale (VAS) for drug liking at peak effect (Emax)
FDA and EMA guidance for human abuse potential studies specifies VAS Drug Liking Emax as the primary endpoint for comparing subjective reinforcing effects to a reference drug.