Drug Development Flashcards
Describe drug and screening and toxicity testingl
Drugs should be cost effective and be likely to be effective. need to test it at variable levels: molecular, cellular, organ system, and whole animal in order to define activity and selectivity of drug as well as pharmacologic profile. You can also study the suspected and unsuspected toxic effects.
- all drugs are toxic at some dose. Toxicity testing needs to determine that limit and the side affects. Determine maximum dose at which specified toxic effect is not seen, minimum lethal dose and LD50.
- Limitations are that its time consuming and expensive, large # of animals may be required, rare side effects not likely to be detected, animal to human isn’t perfect
Describe clinical drug evaluation and regulatory approval
only 1/5000-10000 become an approved drug
describe the major legislation pertaining to drugs in the US
not important for test.
Describe the drug approval process
-need to get approval to initiate clinical trials. The application must contain info on drug source and composition, chemical and manufacturing info, Data from animal studies, proposed clinical plans and protocols, names of Drs conducting trials, and other key info relevant to study.
Describe several phases involved in the investigation of a new drug and discuss the characteristics of each of the phases
*Need IND and IRB for clinical trials
Prephase 1: small # of subjects, short duration (hours to days) and facilitates efficient drug development
Phase 1: 20-100 subjects, several months duration, mainly safety
Phase 2: several 100 subjects, months to 2 years, effectiveness and short term safety
Phase 3: several 100-1000 for 1-4 years, safety/dosage/effectiveness
Phase 4: unlimited subjects, unlimited time duration, observing adverse effects
Describe drug labeling and explain the purpose of black box warnings
Drug labels must include: name of the drug, critical warnings, dosage info, instructions on how to take the drug, foods and drugs to avoid whilst taking the drug, approves use of the drug, contraindications, adverse effects and storage instructions. Black box indicates that the drug carries a significant risk of serious or even life threatening adverse effects.
Explain “off label” drug use
refers to the use of an approved drug for any purpose or in any manner, other than what is described in the drug’s labeling
Ex: antidepressents for insomnia and pain, corticosteroids for cancer pain, antiarrhythmics for neuropathic pain, ipratropium for asthma
Define orphan drugs
drugs for rare diseases. They are difficult to research, develop and market. Low priority because they don’t bring in money.
Orphan diseases: affecting 200000 but no expectation to make back any money.
Describe the 5 schedules of controlled substances
Schedule 1: high potential for abuse, no medical use in US, lack of accepted safety under medical supervision (Heroin) NEVER PRESCRIBE, all non researcj use illegal under federal law
Schedule 2: high potential for abuse, yes to medical treatment in US, Abuse of drug may lead to severe psychological or physical dependence (Amphetamine) NO telephone prescriptions, no refills
Schedule 3: Potential for abuse less than 1 and 2, yes to medical treatment, abuse may lead to moderate or low physical dependence or high psychological dependence (Ketamine) Prescription must be rewritten after 6 months or 5 refills
Schedule 4: Low potential for abuse relative to 3, yes to medical treatment, abuse may lead to limited physical or psychological dependence relative to drugs in schedule 3 (Lorazepam) Same as in 3 but different in penalties for illegal possession
Schedule 5: Potential for abuse less than 4, yes to medical treatment (Pregabalin), as any other nonopioid drug; may also be dispensed without prescription unless additional state regulations apply
