PTCE Chapter One

Pharmacology

the study of drugs and their interactions with living systems

Pharmacokinetics

The process by which drugs are absorbed, distributed within the body, metabolized, and excreted.

absorption

drug molecules travel from site of administration, across cell membranes, and to the circulatory system

distribution

drug travels from circulatory system to barrier membranes to site of action

metabolism

conversion of active drug to a compound easily removed OR conversion of prodrugs to active drugs

elimination

kidney, liver, or bowel

bioavailability

the rate at and the extent to which a nutrient is absorbed and used

Bioequivalence

The rate and extent of absorption of an active ingredient from a drug product so that it becomes available at its site of action.

narrow therapeutic index

small differences in drug dose or blood concentration can be fatal

biosimilars

Products that are highly similar to, or are interchangeable with, an already approved biological product.

purple book

book of biological products and bio similar interchangeables

pharmaceutical equivalent

drug products that contain identical amounts of the same active ingredients in the same dosage form with the same route of administration

pharmaceutical alternatives

drug products that have the same therapeutic effect but differ in the salt, ester or dosage form and are administered by the same route

Therapeutic Equivalence

a drug that is pharmaceutically equivalent and has the same clinical effect and safety profile

A

therapeutically equivalent to other pharmaceutically equivalent products

AA

not presenting bioequivalence problems

AB

meets the necessary bioequivalent requirements

B

not therapeutically equivalent to other pharmaceutically equivalent products

addition

the combined effect of two drugs; it is equal to the sum of the effects of each drug taken alone

antagonism

one drug works against the action of another drug

potentiation

drug interaction that occurs when the effect of one drug is increased by another drug, herbal remedy, or other treatment

synergism

combination of two drugs causes an effect that is greater than the sum of the individual effects of each drug alone

black-box warning

A type of warning that appears in a drug's prescribing information and is required by the U.S. Food and Drug Administration (FDA) to alert prescribers of serious adverse events that have occurred with the given drug.

proprietary name

Name given to a drug by a specific manufacturer; also known as brand name

Nonproprietary name

generic name