Exam 1 Lecture 1 Flashcards
What are Drugs?
substances that change biological function (in subject or an organism) through chemical action
Primary focus of FDA
Enforce the federal food, drug, and cosmetic act.
Roles of FDA
Oversees the drug evaluation process, and grants approval for marketing of new drug products
FDA regulates all food except for
meat, poultry, and some egg products
some FDA roles are shared with ____ , which causes problems at times
USDA
FDA also enforces other was not directly related to food/drugs such as?
lasers, cell phones, and comdoms
4 parts of drug development
- In Vitro studies
- Animal Testing
- Clinical Testing
- Marketing
4 phases of clinical testing
- testing on 20-100 subjects
- testing on 100-200 patients
- testing on 1000-6000 patients
- Postmarketing surveillance
How long does it take for a patent to expire?
20 years
When do you apply for a NDA (New Drug Application)
after phase 3 in clinical testing (after it has been tested on 1000-6000 patients)
When do you apply for an IND (Investigational New Drug)
after animal testing. When it proves to be safe in animals ,IND can be applied for to test in humans. Usually takes about 4 years to get to IND point in timeline.
When do generics become available for drugs?
After patent expires in 20 years
The first two years on the drug development timeline is composed of ______.
In Vitro Studies
Amount of money on average that it takes to put a new drug on the market?
1 billion
What is the CEDR?
FDA’s center for drug evaluation and research
When must and IND be submitted before?
before initiating human clinical trials.
What provides exemption to federal law to allow transport of drugs across state lines for clinical trials?
IND
3 types of INDs
- investigator IND
- Emergency use IND
- Treatment IND
Info required to submit an IND
- Animal pharmacology and toxicology studies
- manufacturing information
- clinical protocols
- investigator information
Application that provides for review of a generic drug application
ANDA
What is an ANDA
Abbreviated new drug application
Focus of ANDA is to demonstrate the product’s _____.
bioequivalence
What act increased the patent length to 20 years?
1984 Drug Price Competition and Patent Term Restoration Act
When do you usually apply for a patent?
When you apply for a NDA
3 parts of Drug Nomenclature
- Chemical name
- Generic Name
- Trade Name
manufacture or brand name is termed as the drugs _____.
trade name
the common name of a drug
generic name
5 members of the US adopted Names Council (USAN)
- AMA
- APHa
- USP
- FDA
- at large
entity that ensures drugs for use in humans to be marketed are safe and effective
CEDR
What is pharmacokinetics?
what the body does to a drug,
or how the drug moves/changes in the body
5 parts to pharmacokinetics (LADME)
- Liberation
- Absorption
- Distribution
- Metabolism
- Elimination
What is medical pharmacology?
the science of substances used to prevent, diagnose, or treat disease.
How can we excrete drugs?
through sweat, breast milk, urine, and feces
The transformation of a drug molecule to something else
Metabolism
what is pharmacodynamics?
What a drug does to the body
What is pharmacotherapy?
How to treat disease and illness with medicine
8 routes of drug administration
- Oral (PO)
- Rectal (PR), Vaginal (PV)
- Intravenous (IV, IV Bolus/continuous)
- intrathecal
- Intramuscular (IM), Intradermal
- topical, intraocular, intraotic
- Subcutaneous (SubQ)
- Intranasal
determines appropriate route and formulation of drugs
Pharmaceutics
Pharmaceutics study the ____, ____, ____, and ____ of pharmaceutical dosage forms
formulation, manufacture, stability, and effectiveness
Study of variation in drug response due to variation in genes (difference how people respond to medication)
Pharmacogenomics
3 types of metabolizers
- poor metabolizer
- extensive metabolizer
- ultra- extensive metabolizer
Poor metabolizer
highest serum (drug)
extensive metabolizer
“normal”/expected serum drug
ultra-extensive metabolizer
lowest serum (drug)
the study of the relationship of the drug at site of action and magnitude of effect produced/
the relationship between concentration and effect
pharmacodynamics
discovery, chemistry, composition, identification, bio-/physiological effects, uses and manufacture of drugs
pharmacology
means by which a new drug sponsor formally proposes that the FDA approve a new pharmaceutical for sale and marketing in the US
NDA
what best describes phase 1 of clinical trials?
main focus is on safety of the drug
