Developing New Medicines

Vocabulary flashcards covering the key stages, trial phases, and regulatory requirements involved in developing new medicines.

Modern Medicine

An evidence-based approach to healthcare requiring a variety of tests to ensure treatments are safe and effective, despite being expensive, time-consuming, and having a high failure rate.

Preclinical Research

The development stage encompassing everything prior to a drug being given to a human for the first time; it uses computer and animal models to determine the cause of a condition, its adverse effects on the body, and possible methods to mitigate those effects.

Clinical Trials

The stages of drug development that involve testing treatments on human populations.

Phase I Clinical Trial

A clinical testing phase conducted on a small population of healthy people to determine drug toxicity and side effects.

Phase II Clinical Trial

A clinical testing phase conducted on a medium population of affected people to determine drug efficacy, dosage, and side effects.

Phase III Clinical Trial

A clinical testing phase conducted on a large population of affected people to identify side effects that may be rare or exist only in specific subpopulations.

Regulatory Approval Criterion

The standard evaluated by a country's government agency after Phase III, where a drug is often approved if its benefits outweigh its risks ($\text{benefits} > \text{risks}$).

Phase IV

The period of continued monitoring following a drug's release to the market to determine whether it requires modification or removal.