Intro To Drug Development: Quiz 1

Question 1

DD

Answer 1

Drug Development

Question 2

Started in late 1800s

Answer 2

Synthetic versions of natural compounds. Ex aspirin from Willow bark tree.

Question 3

Highly Regulated Industry means what is regulated

Answer 3

Safety/Efficacy; Benefits/Risks

Question 4

Global Pharmaceutical market value

Answer 4

1.25 trillion in 2019
And
40% per capita spending

Question 5

Block buster drugs

think $

Answer 5

Sales > $1Billion

Question 6

Top 3 companies

Answer 6

Pfizer $51.75 Bil
Roche $50 Bil
Novartis $47.45 Bil

Question 7

Small molecule characteristics

Answer 7

Low molecular weight
Traditional type
Regulated by CDER
Generic Drugs
Chemical Structure
US NDA/ANDA Application
Example: Asprin, Lipitor

Question 8

Large Molecule Characteristics

Answer 8

High Molecule Weight
Novel Compounds 
Regulated by CBER
Biosimilars
Protein Structure
US BLA Application 
Humors (adilmumab)

Question 9

Types of drugs. Two types give examples.

Answer 9

1. Top selling ex. Humira brand name (Adalimumad)

2. Top prescribed drugs ex. Zestril (Lisinopril)

Question 10

FDA Definition of a Drug

Answer 10

A Substance and biological products. (covered by same laws/Reg.)

Question 11

A Substance is 4 things

Think of vitamin C

Answer 11

1. Official pharmacopeia or formulary
2. Use in diagnosis, cure, mitigation, treatment, or prevention of disease
3. Other than food, affect structure or any function of the body
4. Component of a medicine but not a device

Question 12

3 names associated with a drug

Think of tynenol

Answer 12

1. Trade name
2. Generic name (non proprietary)
3. Chemical name (for active ingredient)

Question 13

International Nonproprietary Names (INN) is established by

Answer 13

Established by the World Health Organization (WHO)

Question 14

WHO does what

Answer 14

Identify pharm substances or active ingredients

Question 15

WHO 3 points with ex.

Answer 15

1. Unique name
2. globally recognized and is public property
3. Single name for a drug or substance worldwide. (Work with INN
   Ex. INN name Paracetamol, US Acetaminophen

Question 16

Ethical Drugs (Rx) 4 points

Answer 16

Prescribed by doctor
Bought at pharmacy like CVS
Use by one person
Regulated by FDA through NDA (new drug application) process

Question 17

OTC Drugs

Answer 17

Drugs that do NOT require a doctor’s prescription
Bought off the shelf
Regulated by FDA through OTC drug monographs
Do not require NDA

Question 18

NDA

Answer 18

New drug application

Question 19

Non-Orphan Products

Answer 19

1

Question 20

Orphan Drug

Answer 20

For those with diseases < or = to 200,000 patients

R&D/ marketing incentives; fee waivers and grants

7 yr exclusivity

Rituximab

Question 21

ODA Orphan Drug Act of 1983

Answer 21

Signed into law on January 4, 1983 by Ronald Reagan.
(Public Law 97-414)
-4 sections

Question 22

Name a rare disease

Answer 22

Huntingtons disease
Myoclonus
ALS (Lou Gehrig’s disease)
Tourette syndrome

Question 23

Generic drug

Also name the year of a certain act

Answer 23

Hatch Waxman Act of 1984
(Drug Price competition and patent term restoration act)

90% of the Rxs filled are generic drugs (FDA)
SAME EVERYTHING

Question 24

Tufts Center for the study of DD May 2019. What is the average cost?

Answer 24

2.6 billion. No refunds

Question 25

Drug discovery and development. What is the phase such as years etc.

Answer 25

Pre discovery
Drug discovery
Pre-clinical
Clinical trials
FDA review
9+years 
LG – scale MFG

Question 26

List the drug development stages there are 4 stages

Answer 26

1. Drug discovery
2. Preclinical drug development
3. Clinical development/manufacturing
4. Marketing application, approval, & post – approval

Question 27

Intro drug discovery and development

2 Approachs:

Answer 27

1. Irrational
   Historical approach
   Screening chemical compounds from natural sources
2. Rational
   Target structure knowledge
   Drug Interaction with target