Pharmaceuticals

Question 1

What is a new drug candidate called before any applications have been filed?

Answer 1

A new molecular entity or a new chemical entity

Question 2

What are Structure-Activity Relationship Studies?

Answer 2

evaluating structural changes to an existing chemical compound

Question 3

What is Structure-Based Drug Design?

Answer 3

using computers to design a drug that binds to the specific target
usually requires the x-ray crystal structure of the target protein

Question 4

What is High-Throughputu Screening?

Answer 4

rapid, automated screening of huge libraries of compounds

usually compounds are prepared by combinatorial synthesis

Question 5

Describe preclinical evaluation

Answer 5

in vitro testing ie bacteria

ADMET in vivo studies i.e. mice

Question 6

What does ADME(T) stand for?

Answer 6

Absorption
Distribution
Metabolism 
Excretion 
(T)oxicity

Question 7

What does ADME(T) not look look at?

Answer 7

efficacy

Question 8

What kind of application is filed if preclinical trials have desirable results?

Answer 8

IND, investigational new drug application

Question 9

Describe phase I of clinical trials

Answer 9

Safety, ADMET, side effects and safe dosage range

less than 100 healthy volunteers

Question 10

Describe phase II of clinical trials

Answer 10

EFFECTIVENESS (first time)
short-term side effects
less than 500 volunteers with targeted disease or symptom

Question 11

Describe phase III of clinical trials

Answer 11

Effectiveness, longer-term side effects, optimum dosage, optimum route of administration
1000s of volunteers with targeted disease or symptom

Question 12

What kind of application is filed if clinical trials are passed?

Answer 12

NDA, new drug application

Question 13

What is pharmacovigilance?

Answer 13

post-market surveillance if drugs

can be withdrawn or restricted if necessary

Question 14

What is photofrin?

Answer 14

the first PDT drug, used for targeting macular degeneration