L4: In vitro methods stimulating the GI tract

Question 1

Preclinical and clinical resting is regulated from

Answer 1

ICH guidelines

Question 2

What is the main purpose of the CMC (chemistry, manufacturing and controls)?

Answer 2

Process development and scale-up

Question 3

Small molecule drugs include?

Answer 3

Organic molecule (<900 daltons)

Question 4

Which of the following is not a commonly used technique for drug screening?

Answer 4

Electron microscopy

Question 5

What is/are the main challenge(s) in oral drug delivery(from a formulation p.o.w)?

Answer 5

Permeability and solubility

Question 6

How many classes are the biopharmaceutical classification system divided into?

Answer 6

4

Question 7

What are the main property of ‘grease ball’ and ‘brickdust’ molecules?

Answer 7

Poor soluble

Question 8

You can improve the solubility of a compound by changing on a molecular, colloidal or particulate level

Answer 8

Yes

Question 9

What is the goal of the developability phase?

Answer 9

Collect and summarize info from preclinical studies on formulation

Question 10

What could the developability assessment consists of?

Answer 10

Physico-chemical characterization

Question 11

The stability of a compound is an important factor. How can this be investigated?

Answer 11

E.g. using heat, light, and various pH values

Question 12

What is the most convenient formulation type for early formulations?

Answer 12

Solution

Question 13

What is the goal of the biopharmaceutics phase?

Answer 13

Increase drug product understanding

Question 14

Which method can you use to determine solubility?

Answer 14

Shake flask

Question 15

In the developability phase, you have

Answer 15

Many compounds and low precision

Question 16

In the biopharmaceutics phase, you have

Answer 16

more detailed and in-depth knowledge compared to developability phase

Question 17

Which class has high solubility and low permeability?

Answer 17

Class 3