PSII Exam I

Question 1

Define quality product

Answer 1

Product that SATISFIES a user’s NEEDS

Question 2

What are three (3) characteristics of quality products

Answer 2

1. Customer (patient) defined
2. Performance based
3. Measurable

Question 3

Define critical quality attributes

Answer 3

A quality attribute that must be controlled within defined limits to ASSURE product meets standards for (1) safety, (2) efficacy, (3) stability and (4) performance.

Question 4

Define Quality by Design by FDA

Answer 4

systematic approach to pharmaceutical develpment to leverages (1) prior knowledge, (2) statistical models (3) mechanistic models (4) quality risk management tools

Question 5

What is product failure?

Answer 5

measure of a lack of quality – inability of a product to SATISFY a users NEEDS

Question 6

List 12 performance characteristics

Answer 6

1. Potency
2. Bioavailability
3. Sterility
4. Chemical stability
5. Solubility
6. Package leaching
7. Taste
8. Odor
9. Appearance
10. Feel
11. Application
12. Dose measurement

Question 7

What are nine (9) performance characteristics relevant to oral administration?

Answer 7

NOT: Sterility, Feel, Application

1. Potency
2. Bioavailability
3. Chemical stability
4. Solubility
5. Package leaching
6. Taste
7. Odor
8. Appearance
9. Dose measurement

Question 8

What are ten (10) performance characteristics relevant to topical administration?

Answer 8

NOT: Sterility, Taste

1. Potency
2. Bioavailability
3. Chemical stability
4. Solubility
5. Leaching
6. Odor
7. Appearance
8. Feel
9. Application
10. Dose measurement

Question 9

What are ten (1) performance characteristics relevant to ophthalmic administration?

Answer 9

NOT: Bioavailability, Taste

1. Potency
2. Sterility
3. Chemical stability
4. Solubility
5. Package leaching
6. Odor
7. Appearance
8. Feel
9. Application
10. Dose measurement

Question 10

What are nine (9) performance characteristics relevant to inhaled administration?

Answer 10

NOT: Taste, Odor, Feel

1. Potency
2. Bioavailability
3. Sterility
4. Chemical stability
5. Solubility
6. Package leaching
7. Appearance
8. Application
9. Dose measurement

Question 11

What are nine (9) performance characteristics relevant to injectable administration?

Answer 11

NOT: Taste, Feel, Application

1. Potency
2. Bioavailability
3. Sterility
4. Chemical stability
5. Solubility
6. Package leaching
7. Odor
8. Appearance
9. Dose measurement

Question 12

Define isotonicity

Answer 12

Solution of interest has same osmotic pressure as biological solution of interest.

Question 13

What are five (5) major performance considerations for IV solutions?

Answer 13

1. Solubility
2. Particulates
3. Precipitation upon injection
4. Dose volume
5. Tightly-controlled neutral pH
6. Bioavailability

Question 14

What are (3) major performance considerations for IM/SQ solutions?

Answer 14

NOT: Dose volume, tightly-controlled neutral pH, bioavailability

1. Solubiility
2. Particulates
3. Precipitation upon injection

Question 15

Where do endotoxins come from?

Answer 15

In lipopolysaccharide (LPS) of cell walls of gram-negative bacteria

Question 16

Name one subset of endotoxins

Answer 16

Pyrogens

Question 17

List three (3) solvents that can be used in injectable solutions

Answer 17

1. ethanol
2. glycerin
3. propylene glycol

Question 18

List four (4) tonicity modifiers

Answer 18

1. Sodium chloride
2. glycerol
3. mannitol
4. dextrose

Question 19

What is the purpose of microbrial preservatives in drug products?

Answer 19

Reduce proliferation of microorganisms

Question 20

What types of products are microbrial preservatives included in?

Answer 20

Products whose formulations can support microbial growth.

Question 21

List four (4) reasons pH control is important

Answer 21

1. maximum solubility
2. maximum stability
3. compatibility with tissues
4. compatibility with membranes