ANSWERS | COMPREHENSIVE STUDY GUIDE 2026/2027
Pre-clincial Stage (Animal testing) of R&D
INDClinical (Safety and effectiveness)
R&DFinal Product Development
Post-marketing
Variations in drug development process - correct answer ✔✔Drug Development Process
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 - correct answer ✔✔Preclinical stage of R&D
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. - correct answer ✔✔Clinical
Stage
1. target identification and validation
2. hit identification and screening
3. lead identification and optimization
4. candidate preclinical and clinical drug development - correct answer ✔✔Drug Discovery
, Drug response is continuous and gradual. The concentration increases, the magnitude of the
effect increases - correct answer ✔✔Graded dose response
-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) - correct
answer ✔✔Types of Drug Response
1) Inactive (R)2) Active (R*)Equilibrium favors inactive state (R) - correct answer ✔✔Receptors
exist in what two states?
1) Ligand-gated ion channel
2) G protein-coupled receptors
3) Enzyme-linked receptors
4) Intracellular receptors regulating gene expression - correct answer ✔✔Four major receptor
families- receptors are proteins that transduce extracellular signals to intracellular responses
- 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. - correct answer ✔✔Ion Channel Receptors / Gated ion channels
-Found in cell membrane