Pharmacology: Drug Standards and Drug Information Sources

This set of vocabulary flashcards covers the drug development process, clinical trial phases, FDA pregnancy risk categories, and various drug information sources based on lecture materials for NCM 106 (Pharmacology).

Food and Drug Administration (FDA)

The government agency that controls the drug development process to ensure drugs are safe and effective.

Drug Development Process Duration

The process from discovery and research to FDA approval, which usually takes an average of $10-15$ years.

Discovery and Development

The first stage of the drug development process where a promising substance is identified and undergoes experimentation.

Preclinical trials

The stage where a drug undergoes laboratory ($\text{in vitro}$) and animal testing ($\text{in vivo}$) to address drug safety issues.

Phase 1 Clinical Trial

A trial where the drug is tested on $20-100$ healthy volunteers or people with the disease to determine its safety and dosage.

Phase 2 Clinical Trial

A trial where the drug is tested on up to several hundred people with the disease to determine its efficacy and side effects.

Phase 3 Clinical Trial

A trial where the drug is tested on $300-3000$ people with the disease to check efficacy and monitor adverse drug reactions.

Phase 4 Clinical Trial

A trial involving several thousand people with the disease to determine the drug's safety and efficacy after initial clinical research stages.

Post-market Safety (PMS) Monitoring

Stage 5 of the development process where the FDA monitors the drug once it is available for use by the public.

Teratogenicity

The capacity of a drug to cause fetal abnormalities when taken by a pregnant mother.

Pregnancy Category A

Adequate and well-controlled studies failed to demonstrate a risk to the fetus in the first trimester, and there is no evidence of risk in later trimesters.

Pregnancy Category B

The drug failed to demonstrate fetal risk in animal studies, and there are no adequate and well-controlled studies in pregnant women.

Pregnancy Category C

The drug demonstrates fetal risk in animal studies, but there are no adequate and well-controlled studies in humans; potential benefits may outweigh risks.

Pregnancy Category D

The drug demonstrates evidence of human fetal risk, though benefits may outweigh risks in potential use.

Pregnancy Category X

Both animal and human studies demonstrate fetal abnormalities or adverse effects; the risk of using the drug outweighs the benefit.

Primary drug information sources

Unpublished studies and original articles in peer-reviewed journals reporting original research, ideas, or opinions.

Secondary drug information sources

Indexing and abstracting systems that organize and provide easy retrieval of primary resources.

Tertiary drug information sources

Sources that summarize data from primary literature, including reference books, drug compendia, and treatment guidelines.

Pharmacopeias

An official code containing a selected list of established drugs with descriptions of physical properties and tests for identity, purity, and potency.

Physician’s Desk Reference (PDR)

An annual publication for prescriber’s use with color-coded indices and photographs of drugs.

Nurse’s Drug Reference

A source of drug monographs arranged alphabetically or per system that includes nursing implications for safe administration.

Monthly Index of Medical Specialties (MIMS)

A drug source providing a prescribing guide to both generic and branded drugs.

Philippine National Drug Formulary

A list of essential medicines registered with the FDA aiming to make quality drugs accessible, efficacious, and affordable.

Package Inserts

A quick drug information source prepared by the manufacturer containing chemical and study information conforming to FDA and BFAD standards.