Phase 1 trials Flashcards
Which phase of clinical studies focuses on investigating the safety and tolerability of a drug?
a) Phase II
b) Phase III
c) Phase I
d) Phase IV
c
What is the purpose of Single Ascending Dose (SAD) studies?
a) Assess the bioavailability of the drug
b) Determine the therapeutic window of the drug
c) Investigate drug interactions
d) Study the drug’s effects on special populations
b
In Multiple Ascending Dose (MAD) studies, how is the dose administered?
a) The dose is gradually increased with each administration
b) The dose remains constant throughout the study
c) The dose is decreased with each administration
d) The dose is randomly varied during the study
b
What does NOAEL stand for in the context of drug testing?
a) No Overwhelming Adverse Effects Limit
b) Non-Observed Adverse Effect Level
c) Noted Occurrence of Adverse Effects Limit
d) Normalized Outcome of Adverse Effect Levels
b
Which parameter is used to determine the Human Equivalent Dose (HED)?
a) Maximum Recommended Starting Dose (MRSD)
b) Minimum Anticipated Biologic Effect Level (MABEL)
c) Pharmacologically Active Dose (PAD)
d) Anticipated Therapeutic Dose Range (ATD)
E. NOAEL
E
What is the purpose of the Maximum Recommended Starting Dose (MRSD)?
a) To determine the therapeutic window of the drug
b) To assess the bioavailability of the drug
c) To calculate the Human Equivalent Dose (HED)
d) To establish a safe starting dose for human trials
d
Which term refers to the dose in animals that exhibits the intended pharmacologic activity of a drug?
a) NOAEL
b) MABEL
c) PAD
d) ATD
c
What does ATD represent in the context of drug modeling?
a) Anticipated Therapeutic Dose Range
b) Actual Therapeutic Dose Result
c) Achievable Toxic Dose Range
d) Anticipated Toxic Dose Result
a
In phase I studies, which population groups are typically included for evaluation?
a) Elderly and pediatric populations only
b) Renal and hepatic impairment groups only
c) Special populations excluding elderly and pediatric populations
d) Elderly, pediatric, renal, and hepatic impairment groups
d
What is the therapeutic window of a drug?
a) The range of doses at which the drug exhibits its maximum effectiveness
b) The range of doses at which the drug is considered safe and effective for use
c) The time period during which the drug remains active in the body
d) The ratio of the drug’s toxic dose to its therapeutic dose
b
What is the therapeutic index of a drug?
a) The range of doses at which the drug exhibits its maximum effectiveness
b) The range of doses at which the drug is considered safe and effective for use
c) The time period during which the drug remains active in the body
d) The ratio of the drug’s toxic dose to its therapeutic dose
d
What is the main difference between therapeutic window and therapeutic index?
a) Therapeutic window refers to the effective dose range, while therapeutic index refers to the safe dose range.
b) Therapeutic window refers to the safe dose range, while therapeutic index refers to the effective dose range.
c) Therapeutic window is determined by clinical trials, while therapeutic index is determined by preclinical studies.
d) Therapeutic window is based on the drug’s pharmacokinetics, while therapeutic index is based on its pharmacodynamics.
a
How is the MRSD calculated?
a. HED/ 10
b. HED / 5
c. NOAEL/10
A
