Drug Development & Laws
This 1906 law prohibited the sale of adulterated or misbranded food and drugs.
First U.S. law prohibiting sale of adulterated/misbranded drugs, sparked by The Jungle.
The “ADME” acronym in pharmacokinetics stands for these four processes.
ADME = the 4 steps of pharmacokinetics.
This term means “the strength of attraction between a drug and receptor.”
Strength of binding between drug & receptor.
“PO” is short for this route of administration.
“PO” = per os = oral administration.
This protein binds drugs in plasma, prolonging half-life.
Major plasma protein binding drugs; increases half-life, reduces free drug. Low albumin = toxicity risk.
This tragedy with thalidomide in the 1960s led to the Kefauver-Harris Act.
Passed after thalidomide caused phocomelia, requiring proof of drug efficacy & safety.
This term describes the fraction of a drug reaching systemic circulation unchanged.
Fraction of drug that reaches systemic circulation unchanged (IV = 100%).
Drugs that bind and activate receptors are called this.
Activates receptor to trigger biological response (e.g., phenylephrine).
This route is used in an EpiPen during anaphylaxis.
EpiPens use IM injection for fast absorption during anaphylaxis.
Lipophilic drugs tend to accumulate here in the body.
Lipophilic drugs accumulate in fat stores, prolonging effects/half-life.
This amendment defines what drugs require a prescription.
Defined which drugs need prescriptions by licensed providers.
This phenomenon lowers bioavailability of orally administered drugs due to liver metabolism.
Oral drugs go through GI & liver before circulation, lowering bioavailability.
The opposite of an agonist, this binds a receptor but stabilizes it into reduced activity.
Binds receptor and decreases activity below baseline (opposite of agonist).
This fast-acting route is often used for nitroglycerin in chest pain.
Nitroglycerin tablets dissolve under tongue for rapid absorption.
This enzyme family in the liver is heavily involved in drug metabolism.
Enzyme superfamily in liver (e.g., CYP3A4) metabolizing most drugs.
This type of warning is the most serious one mandated by the FDA.
The FDA’s strongest warning label for life-threatening adverse effects.
This is the time it takes for plasma drug concentration to fall by 50%.
Time for plasma concentration to fall by 50%, determines dosing intervals.
An antagonist whose effects can be overcome by higher doses of an agonist is this type.
Competitive antagonist effect that can be overcome by higher agonist doses (ex: naloxone).
This absorption method requires ATP to move molecules against a gradient.
Requires ATP and carrier proteins to move against a gradient.
Name two patient factors that significantly affect drug metabolism and elimination.
All alter metabolism/elimination: elderly → slower clearance, obesity → fat storage, renal impairment → toxicity risk.
These two U.S. Acts specifically incentivize development of rare disease drugs and regulate dietary supplements.
Orphan Act incentivized rare-disease drugs; DSHEA regulated supplements. Both in your notes.
This parameter relates the total amount of drug in the body to its plasma concentration.
Ratio of total drug in body to plasma concentration; indicates where drug distributes.
This concept describes the dose range where a drug is effective without unacceptable toxicity.
Range of doses that provide efficacy without unacceptable toxicity.
The process by which the cell membrane engulfs large molecules for transport.
Membrane engulfs macromolecules for transport; ATP-dependent.
This term describes using multiple medications together, often increasing risk of side effects.
Use of multiple meds; raises risk of drug-drug interactions & adverse effects.