The basics 15 pt 1. For each of the following definitions, choose the one drug d

Question

The basics 15 pt 1. For each of the following definitions, choose the one drug development step where that activity is most likely to take place. (4 pt) Activities: a) Verify safety of previously approved drug in new patient population b) Verify drug efficacy in large population(s) c) Define therapeutic window for dosage in normal healthy patients d) Validate the drug target e) Perform in vivo toxicology testing in model animals f) Create Master Cell Bank g) Verify the correct dose-response range h) Define clinical end-points and clinical study design Steps: Discovery Pre-clinical Phase I Phase II Phase III Phase IV 2. Match the following bioprocess steps for the manufacture of biologics with the primary goal of that step. (3 pt) Goals: a) Reduce aqueous volume of bioprocess fluid b) Grow cells that express specific product on large scale c) Manipulate drug form through freezing, drying, etc. to create final drug omm d) Clean cell culture supernatant to protect downstream columns from plugging Physically separate cells from their aqueous medium e) Separate protein product based on characteristics such as molecular weight, size, charge and/or ligand affinity

Explanation / Answer

1)

A) verify safety of previously approved drug - discovery

B) Verify drug efficacy in large population - phase III

C) Define therapeutic window - phase I

D) Validate the drug target - phase II

E) Perform toxicology testing in animals - preclinical

F) Create master cell bank - discovery

G) Verify correct dose response range - phase I

H) Defining clinical end points - phase II

Related Questions

Navigate

• Browse (All)
• Browse T
• Subjects

---

---

Integrity-first tutoring: explanations and feedback only — we do not complete graded work. Learn more.