Fundamentals Week 1 exam Questions
and Answers
Drug Development Process - CORRECT ANSWER-Pre-clincial Stage (Animal testing) of R&D
INDClinical (Safety and effectiveness)
R&DFinal Product Development
Post-marketing
Variations in drug development process
Preclinical stage of R&D - CORRECT ANSWER-1. Drug discovery
2. Biological characterization (drug action/ fate)
3. Pre-formulation studies
4. Initial formulations
5. Manufacturing and controls
6. Package label and design
Clinical Stage - CORRECT ANSWER-Phase 1: Biological effects, safe dosage
Phase 2: New drug treats small amount of patients
Phase 3: Larger size, must be as good as or better than others.
Drug Discovery - CORRECT ANSWER-1. target identification and validation
2. hit identification and screening
3. lead identification and optimization
4. candidate preclinical and clinical drug development
, Graded dose response - CORRECT ANSWER-Drug response is continuous and gradual. The
concentration increases, the magnitude of the effect increases
Types of Drug Response - CORRECT ANSWER--Graded - responses that can be measured (BP, HR,
Diuresis, Bronchodilation, Pain scale, Coma Score)
-Quantal Effects- may or may not occur (convulsions, pregnancy, rash, sleep, death)
Receptors exist in what two states? - CORRECT ANSWER-1) Inactive (R)2) Active (R*)Equilibrium
favors inactive state (R)
Four major receptor families- receptors are proteins that transduce extracellular signals to
intracellular responses - CORRECT ANSWER-1) Ligand-gated ion channel
2) G protein-coupled receptors
3) Enzyme-linked receptors
4) Intracellular receptors regulating gene expression
Ion Channel Receptors / Gated ion channels - CORRECT ANSWER-- Rapid onset and short
duration (muscle contraction)
Transmit signals across the cell membrane by increasing the flow of ions and altering the
electrical potential or separation of charged ions across the membrane
Gated Ion Channel Receptors:
Open or close channels to allow certain ions to pass through cell membrane.
A gated channel for a specific ion. The opening or closing of such channels may alter a cell's
membrane potential.