Pharmaceutics I: Introduction to drugs and pharm 7/6/26

A complete set of vocabulary flashcards covering the introduction to pharmaceutics, active ingredients, regulatory acts, and therapeutic equivalency definitions.

Drug (FDA 1938)

An agent intended for use in the diagnosis, mitigation, treatment, cure, or prevention of diseases in humans or other animals.

Pharmaceutics

The science of dosage form design; it involves all processes of transforming a new chemical entity (NCE) into a medication.

United States Pharmacopeia (USP)

The official pharmacopeia of the United States, first published in 1820, which sets official public standards for prescription and OTC medicines.

Merck Index

An encyclopedia of chemicals, drugs, and biologicals that includes chemical structures, molecular weights, physical data, and therapeutic uses.

Food and Drug Administration (FDA)

The agency responsible for protecting public health by assuring the safety, efficacy, and security of human and veterinary drugs, biological products, and medical devices.

Orange Book

A publication by the FDA titled 'Approved Drug Products with Therapeutic Equivalence Evaluations' which identifies drug products approved on the basis of safety and effectiveness.

Federal Food, Drug, and Cosmetic Act of 1938

A law prompted by the 1937 Elixir Sulfanilamide tragedy that required safety testing of drugs before marketing and gave the FDA authority over drug approval.

Durham-Humphrey Amendment (1951)

Legislation that distinguished between prescription (Rx) and over-the-counter (OTC) drugs and required prescription drugs to be dispensed by licensed practitioners.

Kefauver-Harris Amendment (1962)

A response to the thalidomide disaster that required proof of both safety and efficacy before drug approval and mandated informed consent for clinical trials.

Harrison Narcotic Act of 1914

The first act to address drug diversion, requiring narcotics manufacturers, sellers, and distributors to register with the Bureau of Internal Revenue.

New Chemical Entity (NCE)

A chemical with unknown clinical, toxicological, physical, and chemical properties; considered an API that has not been approved for marketing in the United States.

Active Pharmaceutical Ingredient (API)

The ingredient intended for use in the diagnosis, mitigation, treatment, cure, or prevention of disease.

Drug Product

A finished dosage form (e.g., tablet, capsule, or solution) that contains the active drug ingredient, generally in association with inactive ingredients.

Brand Name

The trade name of the drug.

Chemical Name

The name used by organic chemists to indicate the chemical structure of the drug.

Generic Name

The established, non-proprietary or common name of the active drug in a drug product.

Acetaminophen Chemical Name

$$\text{N-acetyl-para-aminophenol (APAP)}$$

Pharmaceutical Equivalent

Drug products that contain the same active ingredient(s), same dosage form, same route of administration, and are identical in strength or concentration.

Pharmaceutical Alternative

Drug products that contain the same therapeutic moiety but are different salts, esters, or complexes, or are different dosage forms or strengths.

Therapeutic Equivalents

Pharmaceutically equivalent products that produce the same clinical effect and safety profile when administered under the conditions specified in the labeling.

Bioequivalent Products

Drug products that show the same rate and extent of bioavailability.

Pharmaceutical Care (PC)

A component of pharmacy practice involving the pharmacist's direct interaction with the patient to care for drug-related needs.

1969 Code of Ethics (APhA)

A code stating that a pharmacist should hold the health and safety of patients to be the first consideration as an essential health practitioner.