exam 1 prep Q's

Question 1

Why are biologics not typically administered orally?

Answer 1

Would be degraded in acidic/proteolytic environment of stomach/intestines

Question 2

What differentiates phase 1, 2, and 3 clinical trials?

Answer 2

1 – Safety (fewest people)
2 – Efficacy (more people)
3 – Better than available treatment (most people)

Question 3

What is the difference between pharmacokinetics and pharmacodynamics?

Answer 3

PK = what body does to drug (ADME - adsorbed, distributed, metabolized, excretion)
PD = what drug does to body (toxicity)

Question 4

What are the differences between generic small molecule drugs and biosimilars?

Answer 4

Biosimilar is not required to have exact sequence identity due to increased complexity of biologics vs. small molecule drugs

Question 5

What product-related characteristics would promote the immunogenicity of a biologic?

Answer 5

Large size, major structural modifications, non-native sequence, high aggregation

Question 6

What is the EPR effect?

Answer 6

Enhanced permeability and retention; idea that leaky vessels in tumors allow for drugs to accumulate there while dense matrix and larger size of biologics enables retention at the tumor site

Question 7

How do intravenously injected biologics gain access to cells outside the bloodstream?

Answer 7

Via gaps in the vasculature (fenestrated capillaries), transcytosis, and paracytosis

Question 8

How do large, hydrophilic biologic drugs induce responses inside cells?

Answer 8

Endocytosis; e.g. receptor-mediated whereby a cell-surface receptor is bound resulting in subsequent intracellular signaling cascade

Question 9

What are the key limitations of polymer nanoparticles as drug delivery carriers?

Answer 9

Lack of biodistribution control, scalable production is difficult

Question 10

What distinguishes a lipid nanoparticle from a liposome?

Answer 10

Liposome – aqueous and lipid compartments, lipid bilayer
LNP – no aqueous compartment, lipid monolayer, higher stability