Drug development and safety Flashcards
(32 cards)
First 4 steps in the process of drug development
- Isolate or synthesize a new drug
- Determine chemical/pharmaceutical properties of the drug
- Determine the kinetics/dynamics
- Test animals for toxicity (acute, subacute, chronic) and teratogenesis, mutagenesis, and carcinogenesis
Second 3 steps in the process of drug development
- Outline properties of the drug
- Report results of studies
- Propose clinical studies
What does IND stand for
Investigational new drug
What are the steps during the IND application phase of drug development
- outlining properties,
2. report results of case studies, 3. propose clinical studies
What are the steps in the discovery and characterization phase
- Isolate/synthesize new drug
2. Determine chemical/pharm properties of drug
What are the steps during the experimental studies phase of drug development
- Determine kinetics/dynamics of a drug
2. Test animals for toxicity and mutations
What are the steps during the clinical studies phase
Phase 1
Phase 2
Phase 3
What happens during phase 1
Gathering data on drug safety and kinetics in HEALTHY VOLUNTEERS
What happens during phase 2
Gathering data on efficacy, safety, proper dosage in a SMALL group of pts
What happens during phase 3
Obtain statistical evidence of drug safety and efficacy. LARGE group of patients
What are the steps during submission of NDA
- Outline the properties of the drug
- Report results of all experiments and clinical trials
- Propose labeling of drug and clinical indications (for use)
What does NDA stand for
New drug approval
What are the final steps (2) in the drug development process
- NDA approval
2. Postmarketing surveillance
What is the difference between IND and NDA
IND is investigational new drug and it is the early stages of drug (before clinical trials). Where as NDA is the actual approval of the new drug for market
What happens after experimental studies
IND application
What happens after IND application
Clinical studies (phase 1,2,3)
What happens after clinical studies
Submission of NDA application
What is the Federal Food, drug and cosmetic act (FFDCA)
It is a law that was passed in 1938 that allows the FDA to oversee the safety of food, drug, and cosmetics
How has the FFDCA effect drug safety
Drug companies must show that the product is safe before marketing
What was added to the FFDCA in 1968
Drug efficacy study implementation was added.
Drugs had to be studied with controlled trials
What are 2 federal laws/regulations designed to prevent drug abuse
- Harrison Narcotic act of 1914
2. Comprehensive Drug Abuse Prevention and Control Act
What was the purpose of the Harrison narcotic act of 1914
Regulate the production, importation, and distribution of opiates and coca products
What does the comprehensive drug abuse prevention and control act do (aka federal controlled substance act)
Classification of drugs into their 5 schedules
Class 1 drugs
HIGH potential for abuse, no legitimate medical use (cocaine, ecstasy)
