How to Become a Drug Flashcards
Who is the FDA?
Food and Drug Administration
Housed within the Department of Health and Human Services
Responsible for the review and approval of all new drugs before they can be made available to the public
Responsible for recalling drugs that are unsafe
First and prior to applying for drug approval, the manufacturer must do
Preclinical testing which may take 3-6 years
and involves laboratory and animal testing to determine specific biological activity of drug
In vitro testing
test tubes
In vivo testing
animals
What does in vivo testing involve?
Frequency curve
Half-life
Median effective dose
Median toxicity dose
Therapeutic index
What is a frequency curve?
Curve- the number of animals who do or don’t respond to the drug
Half-life
the time it takes the drug to go from 100% to 50%, the shorter the half-life the more frequently it has to be given
Therapeutic index
the higher this number the better, this means there is large difference between the effective and toxic dose
What are the steps in drug testing?
In vitro testing
In vivo testing
IND (investigational new drug)
What is IND?
Investigational New Drug
Testing on people
What is the new drug approval process?
- File for IND status
- show data from in vitro and in vivo testing - Clinical trials
- Submit new drug application (NDA)
- allows physicians to prescribe the new drug - Continuous monitoring of the drug in general population of patients
- adverse and long term effects
How many phases are there in the clinical trial approval process?
3
Phase I of clinical trials
Small number (80-100) of healthy volunteer subjects over a 1-2 year period
Purpose: to check how the body handles the drug and confirm safe dosages
Phase II of clinical trials
Moderate number (100-300) of actual patients over a 2-3 year period
Purpose: to determine effectiveness and short-term side effects or drug interactions
Phase III of clinical trials
Expanded to exceptional populations
Large number (1000-3000) of actual patients over a 3-4 year period
Purpose: to determine effectiveness and short-term side effects or drug interactions of new drug compared to another therapy
Classes of recall
Class 1 recall: reasonable potential for health risk to consumer
Class 2 recall: remote potential for health risk to consumer
Class 3 recall: not likely to cause health risk to consumer (usually involves mislabeling of drug)
FDA approval process (quick run down)
Lab animals: 3-6 years
Clinical Trials: Can take 4+ years
- Phase I: 20-80 healthy individuals
- Phase II: 1000-300 patients with disease, short term effects
- Phase III: 1000-3000 patients for comparison with other treatment
- FDA Approval
- Phase IV: Post marketing monitoring
> Recalls: lot numbers
> Drug Information Resources: PDR, computer resources
> Drug Information Sheets: prepared to create education for consumers and providers
When are drugs withdrawn or recalled?
Adverse effects (usually death)
Incorrect active ingredient
Drug loses effectiveness before expiration date
Contamination
Orphan Drug Act
Provides financial assistance and streamlines process of drug development for rare diseases
- impacts les than 200,000 people
Right to Try Law
May 22, 2018 signed into law by Donald Trump
Created with the intent of allowing terminally ill patients accessexperimental therapies(drugs, biologics, devices) that have completedPhase Itesting but have not been approved by theFDA.
- False hope
- Hasten death or illness
bid
twice a day
tid
three times a day
qid
four times a day
Forms of tablets
Solid
Color and shape vary
- Can help the Pharmacist and Pt tell them apart
Scored
Effervescent
Eneric (coated)
Slow release
Caplets
Lozenges (OTC)
Troche: dissolves in a sugary paste when placed in mouth
