Quiz 3 Flashcards
Produces a defined toxic effect in 50% of the individuals tested
MEC
MTC
Median Effective Dose
Median Toxic Dose
Median Toxic Dose
Produces the desired intensity of effect in 50% of the individuals tested
Median Effective Dose
MEC
Median Toxic Dose
MTC
Median Effective Dose
Area from ICH which includes - stability, light stability, analytical
validation, impurities & biotechnology
Safety topic
Quality topic
Regulatory topic
Efficacy topic
Quality Topic
Regularly schedule subsequent administration to keep the most desirable
concentration of drug in the blood
Loading dose
Therapeutic dose
Prophylactic dose
Maintenance dose
Maintenance dose
Factors in determining drug’s dose, EXCEPT:
Age
Concomitant drug therapy
Pathologic condition
Body weight
Room temperature
Room Temperature
Manufacturing scale-up activities
Phase IV
Determine drug tolerance and toxicity
Phase I
Subjects: Healthy volunteers (20100)
Phase I
Submission of NDA
Phase III
Subjects: Patients with disease (several hundreds-several thousands)
Phase III
Submission of IND
Preclinical Stage
Post Marketing Surveillance
Phase V
Animal Pharmacology and Toxicology data are obtained
Preclinical stage
Determines the therapeutic index
Phase II
Side effects are monitored
Phase III
Determines minimum concentration expected to produce the drug’s
desired effects in a patient
MEC
MTC
Median Effective Dose
Median Toxic Dose
MEC
Therapeutic index is the ratio of drug’s median effective dose & median
toxic dose (EF50/TD50)
True
False
FALSE
Dose that protects the patient from contracting the illness
Loading dose
Prophylactic dose
Therapeutic dose
Maintenance dose
Prophylactic Dose
FDA terminate an IND application for any safety, efficiency or regulatory
compliance issues
True
False
True
A drug product label provides information on the packaging, in package
insert, and in company literature, advertising, and promotion materials
True
False
True
Dose administered to the patient after exposure or contraction of the
illness.
Maintenance dose
Loading Dose
Prophylactic Dose
Therapeutic dose
Therapeutic Dose
Which is NOT a part of a clinical protocol?
Purpose and objectives
Subject selection
Investigational plan
Dosing plan
None of the choices
None of the choices
Which is NOT a component of a drug product label?
Adverse reactions
Warnings
Indications and usage
Suggested retail price
Dosage and administration
Suggested Retail Price
The purpose of NDA is to gain permission to market the drug product
True
False
True
Dosage regimen is determined from:
Clinical investigation
Pharmacokinetics
Characteristics of dosage form
Inherent duration of action
All of the choices
All of the choices
How many days will FDA evaluate/ review a New Drug Application?
within 200 days
within 80 days
within 280 days
within 180 days
Within 180 days
Identify the compounds
Discovery stage
Submission of NDA
Development stage
Human clinical trial phase II
Development stage
Select clinical candidates
Discovery stage
