PSII Final Flashcards
What legislation folowed from Contaminated Smallpox and Diptheria vaccines in 1901-1902?
Biologics Control Act (1902) - purity and safety of vaccines
What legislation followed from Sulfanilamide scare of 1937?
Federal Food Drug and Cosmetics Act (1938) - manufacturers must prove safety
What legislation followed from Thalidomide tragedy in 1962?
Kefauver-Harris Amendment - Manufacturers must prove safety AND efficacy
What legislation followed from Fungal meningitis epidemic in 2012?
Drug Quality and Security Act (2013)
What is the main purpose of the Biologics Price Competition and Innovation Act (2009)?
Create abbreviated FDA approval pathway for biosimilars
What is the main purpose of the Drug Price Competition and Patent Term Restoration Act (1984)? What is the COMMON NAME?
Extention of drug patent terms and introduction of lower generic drugs. Common name is Hatch-Waxman
What is the purpose of the Controlled Substances Act (1970)?
DEA is part of the US Justice Department. Classifies drugs and restricts their distribution by DEA.
What is the purpose of the Durham-Humphrey Amendment (1951)?
defines safe OTC vs Prescription drugs
What is the purpose of the Shirley Amendments (1912)?
Prohibits false therapeutic claims intended to defraud
What is the purpose of the Food and Drug Act of 1906?
Prohibit interstate commerce of INFERIOR (below regulation) drinks and drugs.
What 8 steps in drug dicovery process?
- Identify disease
- Identify molecular mechanism of disease
- Choose therapeutic target in mechanism pathway.
- Develop assay to show activity on target.
- Identity compounds that may be active on target.
- Optimize target-active compound for “proof-of-concept” animal study.
- Optimize molecule for Drug (ADME)
- Clinical trials for safety & efficacy.
Describe phase 1 clinical studies
20-80 healthy volunteers; demonstrate safety
Describe phase 2 clinical studies
100-300 diseased volunteers; demonstrate efficacy and dose
Describe phase 3 clinical studies
1000-3000 diseased volunteers; demonstrate therapeutic efficacy
What is an IND? What is its purpose? (2 componetns)
- Investigational New Drug
2. Process by which an exemption to the law is obtained.
What is an NDA? What is its purpose? (2 components)
- New Drug Application. 2. Vehicle for approval, contains data from animal & human clinical trials.
Define a drug product
Finished dosage form, containing API that is drug substance or biologic.
Define drug substance
Active drug ingredient, usually well-defined chemical entity.
What does FDA abbreviate?
U.S. Food and Drug Administration
What department is the FDA within?
Department of Health and Human Services (HHS)
What are the function of FDA guidelines? (2 components)
- Document agency’s current thinking.
2. Do not confer rights or bind FDA or the public.
What is an ANDA?
Abbreviated New Drug Application
What is the main difference between an NDA and ANDA?
Animal studies, clinical studies and bioavailability are ABBREVIATED with “bioequivalence.”
Define pharmaceutical equivalence
Identical amounts of identical API
Define bioequivalence
Same rate and extent of absorption as reference drug product.
What is the reference drug product?
Brand name drug; Innovator drug
How many composition of generic drug product differ from reference drug product?
Can have different inactive ingredients
What is the “Orange Book?”
All FDA approved drug products listed (NDA, OTC, ANDA)
What are four (4) allowable differences between biosimilar and referenced drug product?
- Formulation
- Delivery device
- Route of administration
- Selected molecular differences
What legislation allows for FDA approval of biosimilars?
Biologics Price Competition and Innovation Act (BPCI)
What is the “purple book?”
All FDA approved Biological products
What are three (3) concerns FDA has with compounding pharmacies?
- Operate as drug manufacturers without cGMP or FDA-imposed controls
- Prepare complex dosage forms without adequate testing/quality assurance
- Past attempts on oversight led to objections and U.S. Supreme Court decision limiting FDA restrictions on advertising
What is the current law that defines responsibilities of FDA and compounding pharmacists?
Drug Quality and Security Act (DQSA)
