Pharmacology Drug Development, Latest Study Guide With Answers 100% Verified.

three stages of drug development - correct answer -preclinical testing ... lab tests then two different species of animals.. (investigational new drug application (IND) to begin clinical research) -clinical research...on humans... then (new drug application (NDA) to get approval from FDA) -post marketing surveillance three phases of clinical trials before FDA approves - correct answer -phase 1: small trials (20-80)in healthy individuals -phase 2: small trials (several hundred) in pts with disease of interest (may be more vulnerable to side effects)... helps determine best dose -phase 3: published, large randomized controlled trials in subjects with disease (clarifies risk to benefit ratio and helps to create drug labels/info) approx time for a drug to be developed and get FDA approval - correct answer 8-15 years 1 in 5000 make it to clinical trials 1 in 5 drugs get approved tylenol is aka... - correct answer -chemical: N-acetyl-para-aminophenol (apap) -generic: acetaminophen -brand: tylenol pharmacokinetics - correct answer -describes what the body does to the drug -how it is absorbed, digested pharmacodynamics - correct answer -describes what the drug does to the body -blocks receptor, decreases BP pharmacotherapeutics - correct answer -rationale use of drugs to prevent/treat/dx a disease receptor - correct answer -like dimmer switches for physiologic functions -ligands bind to receptors to activate or block them agonist - correct answer a ligand that activates a receptor (down regulation) excitatory chemicals: NE, Epi, dopamine, serotonin antagonist - correct answer a ligand that blocks a receptor -prevents effect (up regulation) = increased receptors and NE secretion = withdrawal -Ex: Bblocker, draw a dose-response curve and label the approximate points at which the threshold and plateau doses are achieved - correct answer 3 phases -1: dose too low for a response -2: increasing dose increases response -3: increasing dose no longer increases response -max response occurs when effective receptors are saturated threshold dose - correct answer -line at which dose needs to cross to be effective plateau dose - correct answer -the point at which an increased dose no longer has an increased response potency - correct answer amount of drug required to elicit an effect -morphine is more potent than acetaminophen, need less morphine to reduce pain median effective dose vs median toxic dose - correct answer ED50 = effective dose for 50% of the population LD50= lethal dose which would kill 50% of pts therapeutic index is the space inbetween ED and LD *if there is overlap or a therapeutic index <2.5, monitor pt (blood tests, sx, lab values) interpatient variability - correct answer one dose does not fit all passive transport - correct answer -passive: through phospholipid bilayer -pores and channels -simple diffusion, facilitated diffusion -cells spend little to no energy active transport - correct answer -carrier molecules, exchange pumps -cells spend energy what kind of drugs can go through the blood brain barrier - correct answer -fat soluble drugs -tight formation of capillary epithelial cells with an astrocytic sheath beneath the basement membrane makes it harder for water-soluble drugs to be absorbed into the CNS compartment bioavailability (F) - correct answer proportion of drug does that reaches the systemic circulation absolute bioavailability - correct answer the comparison of the drugs absorption non-intravaneously and intravaneously as a percentage