Chapter 9: Introduction To Pharmaceutical R&D Flashcards
It takes how many years to develop a new drug from the lab to approval by the FDA?
10 - 15 years
(3 - 6 years for pre-discovery)
(6 - 7 years for clinical trials)
(0.5 - 2 years for FDA approval)
How high is the estimated drug cost for a new drug?
1.5 to 1.8 billion dollars.
How many new medicines did the FDA approve in 2012?
39
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?
True
In the last 20 years, the pharmaceutical industry has expanded and co-evolved with an increasingly rigorous regulatory environment. True or false?
True
What percentage of development costs are spent on phase 3 trials?
90%
What is the APhA?
American Pharmaceutical Association
What is the NF?
National Formulary
What are the two major compendia maintained drug standards?
U.S. Pharmacopoeia (USP) and the National Formulary (NF)
What is the USP?
U.S. Pharmacopoeia
The U.S. Pharmacopoeia contains:
All drug products
The National Formulary (NF) contains:
Pharmaceutical ingredients
Drug legislation began to be developed and enforced during what time period?
The 1900s.
The food drug and cosmetic act passed in 1938 prevented what?
The sale of drugs that had not been thoroughly tested.
What is CDER?
The center for drug evaluation and research.
What are black box warnings?
Warnings on the drug boxes that advise potentially very dangerous adverse reactions.
What is CBER?
Center for biologics evaluation and research
What is CFSAN?
Center for food safety and applied nutrition
Herbal products, and dietary supplements are regulated by the dietary supplement health and education act of 1994. True or false?
True
What are the four phases of review of therapeutic drugs and biologics?
1.) pre-clinical investigation.
2.) clinical investigation.
3.) review of the new drug application. (NDA).
4.) post marketing surveillance.
What does pre-clinical investigation involve?
Extensive laboratory research.
What is the second phase of drug testing?
Clinical investigation
What is an NDA?
New drug application
What is an IND?
Investigational new drug application
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?
True
The office of inspector general (OIG) is:
An arm of the department of health and human services, that investigates regulatory infractions, provides compliance advice, and brings enforcement actions.
The federal trade commission (FTC) is:
Regulates general business practices to protect consumers against misleading claims and anti-competitive behavior.
What is the drug enforcement administration (DEA)?
Regulates the distribution and use of narcotics and other controlled substances.
The European medicine agency, those with the FDA does in the U.S. True or false?
True
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?
True
What is PhRMA?
Pharmaceutical research and manufactures of America
What is AMA?
American medical association
The AMA (American medical association) provides ethical guidelines to physicians about appropriate interaction with pharmaceutical companies. True or false?
True
These five public policy initiatives are vital to the support of pharmaceutical innovation:
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
The industry spent 1.3 billion on total R&D in 1997 but an estimated 48.5 billion in 2012. True or false?
True
What laws encourage the transfer of basic research findings to the private sector?
Bayh-Doyle act, and the Stevenson, Wilder Technology Innovation Act.
What is DTC advertising?
Direct to consumer advertising
What is the GAO?
General Accounting Office
One new way to attack cancer cells is with monoclonal antibodies. True or false?
True
