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 blinded Phase III trial uses placebo control. The study drug is a capsule with a distinctive bitter taste. Participants frequently guess their assignment. This is an example of which methodological problem?
Answer: Unblinding due to pharmacological clues
Distinctive organoleptic properties such as taste or smell can unblind participants, compromising the integrity of blinding and introducing performance and reporting bias.
A participant on warfarin enrolls in a trial of an azole antifungal. The azole inhibits CYP2C9. What is the expected pharmacodynamic consequence?
Answer: Increased anticoagulant effect and bleeding risk
CYP2C9 metabolizes the more potent S-warfarin; CYP2C9 inhibition raises warfarin levels, intensifying anticoagulation and increasing hemorrhage risk.
An investigator is designing a First-in-Human (FIH) trial. The starting dose is calculated using the NOAEL from animal studies. The human equivalent dose (HED) is derived by:
Answer: Dividing the animal NOAEL by an allometric scaling factor based on body surface area
HED is calculated by dividing the animal NOAEL (in mg/kg) by a body surface area conversion factor (Km ratio), then applying a safety factor to determine the maximum recommended starting dose.
In a trial, drug X has a narrow therapeutic index and is 95% protein-bound. A co-administered drug Y displaces X from albumin binding sites. What is the immediate pharmacokinetic effect?
Answer: Transient increase in free (unbound) drug X, rapidly corrected by increased clearance
Protein displacement briefly raises free drug levels, but the increased free fraction also increases clearance and distribution, usually returning unbound concentrations to near-baseline rapidly.
A participant in an oncology trial develops grade 3 thrombocytopenia (platelets 25,000/µL). Per ICH E6 GCP guidelines, what is the investigator's primary obligation regarding this event?
Answer: Assess causality, treat the participant, and report as a serious adverse event to the sponsor
Grade 3 thrombocytopenia is serious; the investigator must ensure participant safety, assess causality, and report the SAE to the sponsor within required timeframes per ICH E6.
A study evaluates an inhaled bronchodilator. Pharmacodynamic endpoints include FEV1 improvement. Which PK/PD model best describes the relationship between bronchodilator plasma concentration and FEV1 response?
Answer: Sigmoidal Emax (Hill) model
The sigmoidal Emax model describes pharmacological responses that plateau at maximum effect (Emax) with a sigmoidal concentration-response curve characterized by EC50 and the Hill coefficient.
A trial sponsor changes the reference safety information (RSI) to remove a previously listed adverse event. How does this affect reporting obligations for that event going forward?
Answer: Events previously labeled as expected now become unexpected, triggering expedited SUSAR reporting
The current RSI at the time of the event determines whether an adverse reaction is expected or unexpected; removing an event from the RSI reclassifies it as unexpected, requiring SUSAR reporting.