Reading...
Play button
Play button
Use LEFT and RIGHT arrow keys to navigate between flashcards;
Use UP and DOWN arrow keys to flip the card;
H to show hint;
A reads text to speech;
32 Cards in this Set
- Front
- Back
|
Who establishes drug standards?
|
The United States Pharmacopeia Convention (USP).
i.e. congress makes laws. |
|
|
Who supervises the USP standards?
|
The FDA.
i.e. police enforces laws. |
|
|
What does the FDA do?
|
Monitors discovery and development
USP sets standards (purity, how much, etc). FDA ensures standards are followed. |
|
|
What kind of standards does USP include?
|
purity and levels of impurities, packaging and storage, analysis and procedures.
|
|
|
What is the composition of the USP convention?
|
Scientists, pharmacists, physicians, non-medical personel, non government personel
|
|
|
How is drug content expressed?
|
As a percent of the labeled amount.
|
|
|
How do you determine range of the drug content?
|
By multiplying the labeled amount by the percent range.
i.e. Diazepam 90%-110% 5mg. 0.9 x 5 = 4.5mg 1.1 x 5 = 5.5mg Range = 4.5-5.5mg |
|
|
What are some specific tests for dosage forms (i.e. tablets and capsules).
|
Dissolution or drug release
disintegration physical tests (uniformity, size). |
|
|
What must happen before the drug is marketed to the public?
|
Drug must be approved by the FDA.
|
|
|
Describe pre-clinical studies.
|
Preformulation --> formulation --> In-vitro and in-vivo studies.
|
|
|
Describe preformulation.
|
Synthesis of a drug.
Look at chemistry, physical properties, biology, label design, toxicity, manufacturing, physical form, solubility, partition coefficient, dissolution rate, stability, etc. |
|
|
How long does a preclinical study take?
|
6.5 years.
|
|
|
What does in-vitro and in-vivo mean?
|
In-vitro = not alive cells.
in-vivo = Live animal study. |
|
|
What are the steps to get a drug approved by the FDA?
|
Pre-clinical studies --> clinical studies --> FDA review --> Postmarket surveillance.
|
|
|
When studies are done, whats given to the FDA for review? How long does it take?
|
30 Day review.
Contact information, preclinical data, clinical data, study design, protocals, purpose, objective, etc. (everything). |
|
|
Where are the two places the drug research data can be sent to in the FDA?
|
Center for drug evaluation and research
OR Center for biological evaluation and research. |
|
|
What are the three types of study designs for clinical studies?
|
Placebo-controlled
double-blind crossover with/without washout |
|
|
What does a placebo controlled design mean?
|
Group is given either a placebo or the drug. They must look exactly alike to avoid bias.
|
|
|
What does double-blind design mean?
|
Patients do not know whether they are receiving drug or not.
Eliminates bias in dispensing and recording data. |
|
|
What does crossover with/without washout design mean?
|
Swap groups after a period of time.
Eliminates bias in randomization among groups. Washout means a one week period of no drugs (placebo only) to clean out system. |
|
|
Describe phase 1 clinical study.
|
20-100 healthy or /w target disease
Physicians that are experts in clinical investigations Assessing safety and effectiveness 1.5 years. |
|
|
Describe phase 2 clinical study.
|
100-500 all with target disease.
Physicians that are experts in clinical investigations and disease field. Assessing safety and effectiveness 2 years. |
|
|
Describe phase 3 clinical study.
|
1,000 - 5,000 with target disease.
Opened up to patients with target disease and different disease states. Multicenter trial Even larger number of physicians involved (do not have to be experts). Assess safety, effectiveness, and evaluate dosage. |
|
|
After clinical studies are done, whats next?
|
New drug application.
1.5 year review by FDA to gain permission to market. FDA is given all info in preclinical and clinical trials, also samples of the drug to do their own research. Labeling - Ensure safe and appropriate use of the production. |
|
|
To get a new drug to market, about how long does it take, what are the odds?
|
15 years total.
5,000 drugs researched --> 5 make it to clinicals --> 1 drug approved. |
|
|
What happens after approval by FDA?
|
Postmarketing surveillance.
|
|
|
During postmarketing surveillance, what must the company do?
|
Provide reports of adverse reactions quarterly for three years.
After three years, an annual report. |
|
|
What happens if a drug is not profitable?
|
Its pulled.
|
|
|
What is FDA Medwatch Program?
|
Used by pharmacists and healthcare practitioners to report adverse drug experiences to the FDA.
|
|
|
For generic drugs, what must be filed with the FDA?
|
Abbreviated new drug application.
|
|
|
What must a company have to sell a generic drug?
|
Proof of biological equivalency.
Provide documentation to demonstrate chemistry, manufacturing, and bioavailability to demonstrate biological equivalency to brand name. |
|
|
Why develop generic drugs?
|
Saves time and money!
Don't have to go through strenuous new drug research. |
