Chapter 9: Introduction To Pharmaceutical R&D

Question 1

It takes how many years to develop a new drug from the lab to approval by the FDA?

Answer 1

10 - 15 years

(3 - 6 years for pre-discovery)
(6 - 7 years for clinical trials)
(0.5 - 2 years for FDA approval)

Question 2

How high is the estimated drug cost for a new drug?

Answer 2

1.5 to 1.8 billion dollars.

Question 3

How many new medicines did the FDA approve in 2012?

Answer 3

39

Question 4

For every 5,000 to 10,000 compounds that enter R&D only one is approved by the FDA as a new medicine. True or false?

Answer 4

True

Question 5

In the last 20 years, the pharmaceutical industry has expanded and co-evolved with an increasingly rigorous regulatory environment. True or false?

Answer 5

True

Question 6

What percentage of development costs are spent on phase 3 trials?

Answer 6

90%

Question 7

What is the APhA?

Answer 7

American Pharmaceutical Association

Question 8

What is the NF?

Answer 8

National Formulary

Question 9

What are the two major compendia maintained drug standards?

Answer 9

U.S. Pharmacopoeia (USP) and the National Formulary (NF)

Question 10

What is the USP?

Answer 10

U.S. Pharmacopoeia

Question 11

The U.S. Pharmacopoeia contains:

Answer 11

All drug products

Question 12

The National Formulary (NF) contains:

Answer 12

Pharmaceutical ingredients

Question 13

Drug legislation began to be developed and enforced during what time period?

Answer 13

The 1900s.

Question 14

The food drug and cosmetic act passed in 1938 prevented what?

Answer 14

The sale of drugs that had not been thoroughly tested.

Question 15

What is CDER?

Answer 15

The center for drug evaluation and research.

Question 16

What are black box warnings?

Answer 16

Warnings on the drug boxes that advise potentially very dangerous adverse reactions.

Question 17

What is CBER?

Answer 17

Center for biologics evaluation and research

Question 18

What is CFSAN?

Answer 18

Center for food safety and applied nutrition

Question 19

Herbal products, and dietary supplements are regulated by the dietary supplement health and education act of 1994. True or false?

Answer 19

True

Question 20

What are the four phases of review of therapeutic drugs and biologics?

Answer 20

1.) pre-clinical investigation.

2.) clinical investigation.

3.) review of the new drug application. (NDA).

4.) post marketing surveillance.

Question 21

What does pre-clinical investigation involve?

Answer 21

Extensive laboratory research.

Question 22

What is the second phase of drug testing?

Answer 22

Clinical investigation

Question 23

What is an NDA?

Answer 23

New drug application

Question 24

What is an IND?

Answer 24

Investigational new drug application

Question 25

Black box warning’s continue to warn patients that fatal cardiovascular disease, bleeding ulceration, and serious gastrointestinal reactions may result if certain precautions are not taken. True or false?

Answer 25

True

Question 26

The office of inspector general (OIG) is:

Answer 26

An arm of the department of health and human services, that investigates regulatory infractions, provides compliance advice, and brings enforcement actions.

Question 27

The federal trade commission (FTC) is:

Answer 27

Regulates general business practices to protect consumers against misleading claims and anti-competitive behavior.

Question 28

What is the drug enforcement administration (DEA)?

Answer 28

Regulates the distribution and use of narcotics and other controlled substances.

Question 29

The European medicine agency, those with the FDA does in the U.S. True or false?

Answer 29

True

Question 30

The pharmaceutical research and manufactures of America (PhRMA) is one of the most powerful and influential groups for the development of industrywide guidelines. True or false?

Answer 30

True

Question 31

What is PhRMA?

Answer 31

Pharmaceutical research and manufactures of America

Question 32

What is AMA?

Answer 32

American medical association

Question 33

The AMA (American medical association) provides ethical guidelines to physicians about appropriate interaction with pharmaceutical companies. True or false?

Answer 33

True

Question 34

These five public policy initiatives are vital to the support of pharmaceutical innovation:

Answer 34

1.) continued public support for biomedical research.

2.) rigorous, efficient, and transparent regulation of pharmaceuticals.

3.) understanding the value of pharmaceuticals.

4.) avoiding new pharmaceutical price controls.

5.) Maintaining the Hatch-Waxman act balance

Question 35

The industry spent 1.3 billion on total R&D in 1997 but an estimated 48.5 billion in 2012. True or false?

Answer 35

True

Question 36

What laws encourage the transfer of basic research findings to the private sector?

Answer 36

Bayh-Doyle act, and the Stevenson, Wilder Technology Innovation Act.

Question 37

What is DTC advertising?

Answer 37

Direct to consumer advertising

Question 38

What is the GAO?

Answer 38

General Accounting Office

Question 39

One new way to attack cancer cells is with monoclonal antibodies. True or false?

Answer 39

True