Drug Development Process / Manufacturing Practices

Question 1

Describe the main steps of the drug development process

Answer 1

1. New chemical entity
2. Preclinical studies
3. Investigational new drug application
4. Both Clinical trials (Phase I-III) and Preclinical studies (agiain)
5. New Drug Application
6. Postmarketing

Question 2

List and describe FDA’s responsibilities

Answer 2

Protecting and advancing the public health

Question 3

FDA’s definition for ‘New Drug’

Answer 3

An active ingredient that has never been marketing in the USA in some form

Question 4

What does FDA stand for

Answer 4

Food and Drug Administration

Question 5

Describe Clinical Phase 1

Answer 5

1. 20-100 pt
2. Up to 1 year
3. Purpose: safety
4. 70% drugs are successfully tested

Question 6

Describe Clinical Phase 2

Answer 6

1. 100-500 pt
2. Several months to 2 years
3. Purpose: short-term safety, but mainly effectiveness
4. 33% drugs are successfully tested

Question 7

Describe Clinical Phase 3

Answer 7

1. 1000-5000 pt
2. 1-4 years
3. Safety, effectiveness, dosage
4. 25-30% drugs are successfully tested

Question 8

What is manufacturing?

Answer 8

Large scale, well-defined products produced by pharma companies

Question 9

What is compounding?

Answer 9

Small scale, pt-specific produced in compounding pharmacies

Question 10

What are some reasons why there has been an increase in compounding pharmacies?

Answer 10

1. Dose, strength, dosage form, allergy requirements
2. Collaborate to deliver innovative products
3. Veterinary applications
4. Drugs reported in literature but not yet manufactured

Question 11

What is a container?

Answer 11

Holds and may be in direct contact w/ article

Question 12

What is an immediate container?

Answer 12

In contact w/ article at all times

Question 13

What is the pro of glass containers?

Answer 13

1. Resist deterioration
2. Water permeability
3. Amount of alkali in glass

Question 14

What is Type I, II, III glass containers?

Answer 14

Decreasing resistance; used for parenteral products

Question 15

What is Type NP glass container?

Answer 15

Least resistance and used for other products

Question 16

What is the pro of plastic containers?

Answer 16

1. Reduced weight and impact resistant
2. Versatility in design
3. Consumer preference in squeeze bottles
4. Popularity of blister packaging

Question 17

What are the cons of plastic containers?

Answer 17

1. Permeability to air and moisture
2. Leaching into internal contents
3. Sorption of drug to container
4. Transmission of light thru container
5. Alteration of container during storage

Question 18

What is a child resistant container?

Answer 18

Significantly difficult for children under 5yo to open

Question 19

Who are exempted from the child resistant containers?

Answer 19

Seniors and arthritis pt

Question 20

What happens if an OTC is exempt from child resistant tops?

Answer 20

They just have to be labeled that package is not child resistant

Question 21

What are the issues with compliance packaging?

Answer 21

1. Misunderstanding of dosing schedule
2. Confusion due to too many Rx
3. Forgetfulness
4. Feeling of well-being

Question 22

What are the manufacturer’s labels?

Answer 22

Label on immediate container (lot, name, dosage, etc)

Question 23

What are the prescription labels?

Answer 23

Ones placed by pharmacist on dispensed medication

Question 24

What are the OTC labels?

Answer 24

Standardized format set by FDA which has bar code and drug facts box; has to be understood especially by seniors