DLA Drug Development Flashcards
What are the goals of pre clinical safety and toxicity testing and what quantitative estimates are sough after during this testing?
Predict and identify toxic items to be monitored in clinical trials
No effect dose: max dose at which a specified toxic effect is not seen
Minimum lethal dose: smallest dose that kills an experimental animal
LD50
Limitations of preclinical testing
- time consuming and expensive
- animal data to humans are not always correct
- need a lot of animals
- rare and adverse effects are unlikely to be detected
What is the purpose of Prephase I of a clinical trial?
To facilitate efficient drug development
Studies are limited to low doses of the drug and short durations of treatment and small amount of subjects
Phase I of clinical trial goals and details
Goals: establish safety, toxicity, pharmacokinetics and major adverse effects of the drug
Carried out in small number of healthy normal subjects and they at first receive small doses and then increase dosage thereafter
What are the outcomes of Phase 1 trials?
Maximum tolerated dose, measurements of absorption, distribution, metabolism and excretion
Gives info to determinate appropate dose adn frequency for phase 2 and 3
What kind of people are subjects in a phase 2 clinical trial and what are the goals of phase 2?
Several hundred patients who have the medical condition of interest
What to get information about the efficacy of the drug and look at dosing regiments and can reveal broader range of adverse effects
What kind of subjects are being studied in phase 3 and what are the details
Much larger numbers (hundreds of thousands) of patients with the target disease and trials are conducted in similar settings to those anticipated for the drugs ultimate use (randomized, controlled double blind trials)
Further establish safety and efficacy
us
What are the phase 3 trial outcomes based on?
Outcomes are based on specific endpoints, mainly primary endpotisn such as survival and improvement of patients functional status
What is the goal of phase 4 trials?
Observe adverse effects that are rare or due to chronic dosing
Off label use for antidepressants
Treatment of insomnia and pain
Off label use of antiarrhythmics
Treating neuropathic pain
Schedule 1 drug details
Non reserrach drugs that are illegal under federal law;
Ex. Heroin
Schedule 2 details and example
No telephone prescriptions and no refills
Ex. Amphetamines
Difference between schedule 3 and 4 drug
Penalties for illegal possession
Both require a prescription to be rewritten after 6 months or 5 refills
Schedule 3: ketamine
Schedule 4: lorazepam
