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Respect for Persons
Treating patients as independent decision-makers and protecting those with diminished capacity.
Beneficence
The duty to protect research subjects from harm and ensure that the benefits outweigh the risks.
Justice
Fair selection of research subjects that reflects all social classes and ethnic groups.
Phase 1 of Clinical Trials
Involves small groups of healthy volunteers to evaluate safety and side effects of a drug.
Phase 2 of Clinical Trials
Tests drugs on patients with the disease to assess therapeutic effects and safety.
Phase 3 of Clinical Trials
Involves larger populations to monitor adverse effects in a clinical market.
Phase 4 of Clinical Trials
Post-marketing surveillance to assess the drug's effects in various populations.
Absorption
The process by which a drug enters the body, influenced by disintegration and dissolution.
Active Transport
A mechanism requiring energy to move drugs against a concentration gradient.
Bioavailability
The percentage of administered drug available for activity in the body.
Additive Drug Interaction
When two drugs administered together have a combined effect equal to the sum of their effects.
Synergistic Drug Interaction
When the combined effect of two drugs is greater than the sum of their individual effects.
Antagonistic Drug Interaction
When one drug reduces or blocks the effect of another drug.
Half-Life
The time required for 50% of a drug to be eliminated from the body.
Therapeutic Index
The ratio between a drug's therapeutic dose and its toxic dose, indicating safety.
Pharmacogenetics
The study of how a person's genetic makeup influences their response to drugs.
Side Effects
Expected secondary effects of a drug that occur regardless of its primary purpose.
Adverse Effects
Unexpected and severe effects of a drug that may require reporting to regulatory agencies.
Peak Level
The highest plasma concentration of a drug, indicating its absorption rate.
Trough Level
The lowest plasma concentration of a drug, indicating its elimination rate from the body.
Controlled Substances Schedule I
Drugs with no accepted medical use and a high potential for abuse (e.g., heroin, LSD).
Chemical Name of Drug
A name reflecting the drug's chemical structure, usually in lower case.
Generic Name of Drug
The original, universally accepted name given to a drug that is not owned by any company.
Brand Name of Drug
The trade name given to a drug by the pharmaceutical company, usually capitalized.
Over the Counter (OTC) Drugs
Medications available without a prescription that can still pose risks if misused.
Six Rights of Medication Administration
Rights to ensure safe drug administration: right patient, drug, dose, route, time, and documentation.
disintegration
The process by which a solid dosage form breaks down into smaller particles to release the active drug for absorption.
dissolution
The process by which the active drug dissolves in a solvent, allowing for absorption into the body.
Distribution depends on
vascular permeability and permeability of cell membrane, regional blood flow and pH, drugs lipid solubility, and protein binding plasma
most important protein binding plasma
albumin
another term for metabolism
biotransformation
metabolism
the chemical processes that modify and break down substances in the body.
pro drug
a medication that is administered in an inactive form and converted into an active form within the body.
steady-state/loading dose
the concentration of a drug in the body that remains constant after repeated doses, achieved when the rate of drug administration equals the rate of elimination.
Excretion
the process by which waste products and drugs are eliminated from the body, primarily through urine or feces.
body system associated with metabolism
liver
body system associated with excretion
kidneys, lungs, and breast milk
first pass
refers to most oral drugs because they become metabolized as they pass through body, more specifically the liver, and lose effectiveness
Describe the influence of protein binding on drug bioavailability
Protein binding affects drug bioavailability by limiting the free, active form of the drug that can exert therapeutic effects. Highly protein-bound drugs may have lower bioavailability as only the unbound fraction is available to cross cell membranes and interact with target receptors.
those who benefit from pharmacogenetics:
take multiple prescription drugs, not responding to current therapy, having adverse drug reactions, taking black box warning drug
Identify the safety and accountability related to controlled substances.
5 different schedules to classify controlled substances, from I-V, I being most dangerous with highest potential to be abused, V with lowest potential to be abused
Schedule 2
A classification of controlled substances that have a high potential for abuse, leading to severe psychological or physical dependence. Examples include opioids like oxycodone and stimulants like amphetamine.
schedule 3 drugs
these drugs, substances, or chemicals are defined as drugs
with a moderate to low potential for physical and psychological
dependence. this drugs abuse potential is less than
Schedule I drugs but more than Schedule V.
Schedule IV drugs
these drugs, substances, or chemicals are defined as drugs
with a low potential for abuse and low risk of dependence.
Schedule V drugs
these drugs, substances, or chemicals are defined as drugs
with lower potential for abuse than Schedule IV and consist of
preparations containing limited quantities of certain narcotics.
these drugs are generally used for antidiarrheal, antitussive, and analgesic purposes.
factors affecting bioavailability
drug form, route of administration and effects on absorption, gastric mucosa and motility, and changes in liver metabolism
potency
the amount of a drug needed to produce a specific physiological
response to a drug
Tachyphylaxis
Acute, rapid decrease in drug responsiveness. Can occur after the first
dose or after several doses