Clinical Trials & Toxicology Flashcards
The pharmacological result, either desirable or undesirable, of drugs interacting with themselves or with other substances
OTC drugs, foods, herbal and ‘nutritional’ supplements are potential sources
Drug interactions
Describes drug interactions when both of the interacting drugs have similar action
Homergic
Describes drug interactions when only one of the drugs is active in the behavioral measure employed; other lacks the effect
Heterergic
Drug interaction type where the drugs are chemically incompatible
Physiochemical
Drug interaction type where absorption, distribution, biotransformation or elimination is altered for one or both drugs
Pharmacokinetic
Drug interaction type that is typically used for drugs interacting at the same site or mechanisms
Pharmacodynamic
3 types of drug interaction types in order
Physiochemical
Pharmacokinetic
Pharmacodynamic
Term that describes:
Effective in 50% of test population
Produces half the maximal response
Effective dose 50 (ED50)
Term that describes:
Lethal in 50% of test population
Produces half the lethal response
Lethal dose 50 (LD50)
Term that describes:
Toxic in 50% of test population
Produces half the toxic response
Toxic dose 50 (TD50)
Equation for therapeutic index (TI) aka therapeutic window
TI = TD50 / ED50
Are large or small values of therapeutic index (TI = TD50 / ED50) good?
Large
Takes a lot more drug to make people sick than it does to make them well
Equation for certain safety factor (CSF) aka margin of safety
CSF = TD1 / ED99
Which is typically a better measure of safety, therapeutic index (TI) or certain safety factor (CSF)?
Certain safety factor (CSF)
CSF = TD1 / ED99
TI = TD50 / ED50
Are large or small values of Certain safety factor (CSF = TD1 / ED99) good?
Large
Toxicology term:
Heritable change in genetic material
Limited to effects on nucleic acids
Mutagenesis
Toxicology term:
Change in genetic material resulting cancer
Carcinogenesis
Toxicology term:
Changes in genetic material resulting in congenital malformations that are grossly visible at birth
Typically related to drug-related change in first trimester
Teratogenesis
What is meant by: Cell injury or death during the first two weeks of pregnancy may not be teratogenic (all or nothing)
Fetus killed, OR
Damaged cells replaced by undifferentiated cells without long-lasting consequences
Vulnerability to a specific drug’s teratogenic effect may be greatest during specific periods of development, specifically:
Highly vulnerable from weeks 3-8
Can men have teratogenic risk?
Yes (e.g. systemic retinoids)
Can teratogenic risk persist long after drug administration?
Yes (e.g. systemic retinoids)
This type of drug application may be better when nursing infants as lower systemic levels generally occur
topical
Law that required proof of safety and effectiveness
Explanation: Dr. Kelsey of USD did not approve thalidomide due to it being unsafe
Harris-Kefauver Amendment of 1962
Administration that enforces drug laws
Drug Enforcement Administration (DEA)
Phase of FDA approval of a new drug:
Includes animal testing
Acute, subacute, chronic and reproductive toxicity evaluation
Requires multiple species
Basic pharmacokinetic profile established
Basic pharmacodynamic profile established
Includes extensive in vitro testing
Preclinical phase
Phase of clinical phase during FDA approval of a new drug:
Determines effects, safety, dosage and pharmacokinetics
Healthy volunteers
Phase I
Phase of clinical phase during FDA approval of a new drug:
Is it safe and effective?
Small number of patients with the disorder
Phase II
Phase of clinical phase during FDA approval of a new drug:
Is it safe and effective when used in a larger more diverse patient population?
Phase III
Phase of clinical phase during FDA approval of a new drug:
Postmarketing surveillance, aka pharmacovigilance
Monitor problems that occur after NDA approval and report to manufacturer or FDA
Primary focus on adverse effects, compliance, and drug interactions
Phase IV
Class of controlled substances:
The controlled substances in this schedule are those that have no accepted medical use in the US, are not accepted as safe for use under medical supervision, and have a high abuse potential
Ex: Heroin, lysergic diethylamide (LSD), marijuana, peyote, methaqualone and certain fentanyl and meperidine analogs
Schedule I (CI)
Class of controlled substances:
Have high abuse potential with severe psychological or physical dependence liability, but have accepted medical use in the US
Ex: morphine, phencyclidine, methadone, cocaine, methamphetamine
Special prescribing concerns
Schedule II (CII)
Class of controlled substances:
Have abuse potential and dependence liability less than those in previous schedules, and have accepted medical use in the US
Ex: anabolic steroids, codeine and hydrocodone with aspirin or acetaminophen, some barbiturates
Schedule III (CIII)
Class of controlled substances:
Have abuse potential and dependence liability less than those listed in the previous schedule and have an accepted medical use in the US
Ex: Diazepam and pentazocine
Schedule IV (CIV)
Class of controlled substances:
Have abuse potential and dependence liability less than those listed in previous schedule and have an accepted medical use in the US
Ex: cough medications with codeine, antidiarrheal containing low doses of opiates, and some analgesics
Schedule V (CV)
Federal regulation under the authority of the ______ determines what is a prescription drug and what is not
FDA
Means of conveying treatment intentions to the patient, pharmacist or other health care professionals
Represents the end of a diagnostic process
Prescription
