New Drug Approval Process Updated

High-Throughput Screening (HTS) is best described as:

• Screening only natural metabolites for activity

• An industrialized, automated process to rapidly test of compounds for activity

• Clinical observations during human studies

• Random use of plant extracts to test for drug activity

According to the FDA, which of the following circumstances would classify an old drug as “new”?

• Repackaging without formulation changes

• A new combination or proportion of existing drugs

• Price adjustments

• Expired patents

Which term describes a prototype molecule with desired activity but poor ADME properties?

• Goal drug

• Lead compound

• Drug candidate

• Prodrug

Aspirin is considered a prodrug because:

• It requires metabolic conversion to salicylic acid to become active

• It has poor absorption and must be injected

• It is resistant to first-pass metabolism

• It is fully active in unchanged form

Sildenafil (Viagra) was originally developed for hypertension but later found to treat erectile dysfunction. This discovery method is classified as:

• Random screening

• Rational drug design

• Clinical observation

• High-throughput screening

Which of the following best describes potency?

• The ability of a drug to produce the maximum biological effect

• The strength of the biological effect at a specific concentration

• The duration of the drug effect

• The selectivity of a drug for its receptor

Which of the following is NOT a component of preclinical studies?

• Toxicology studies

• Pharmacokinetic (ADME) studies

• Stability and solubility testing

• Phase I human clinical trials

The main purpose of an IND application is to:

• Gain marketing approval for a new drug

• Ensure safety of human subjects before clinical trials begin

• Demonstrate bioequivalence of a generic drug

• Obtain exclusivity rights for rare disease drugs

Phase II clinical trials primarily focus on:

• Human safety in small groups

• Dose finding and preliminary efficacy

• Confirming efficacy in large populations

• Postmarketing surveillance

Which of the following is characteristic of Phase III trials?

• Conducted in 20–80 volunteers

• Randomized, blinded studies for dose-ranging

• Performed exclusively in animals

• Risk-Benefit relationship of the drug and address special issues