Investor Glossary

Alphabet

CNS (Central Nervous System)

The central nervous system.

DDS (Drug Delivery System)

Drug delivery technologies designed to deliver the required amount of a drug to a target site at the necessary time to enhance therapeutic efficacy and reduce side effects.

Development Pipeline

Refers to compounds that are candidates for new drug development.

EMA (European Medicines Agency)

The European Medicines Agency.

FDA (Food and Drug Administration)

The U.S. Food and Drug Administration.

GCP (Good Clinical Practice)

Standards for conducting clinical trials of pharmaceuticals.

Generic Drugs

Drugs that have the same active ingredients, administration route, dosage and usage, and indications as an already-approved drug. They are generally launched after the reexamination period and patent period of the original drug expire.

GLP (Good Laboratory Practice)

Standards for conducting non-clinical safety studies of pharmaceuticals.

GMP (Good Manufacturing Practice)

Standards for manufacturing control and quality control of pharmaceuticals and quasi-drugs.

GPSP (Good Postmarketing Study Practice)

Standards for conducting post-marketing surveys and studies of pharmaceuticals.

GQP (Good Quality Practice)

Standards for quality control of pharmaceuticals, quasi-drugs, cosmetics, and medical devices.

GVP (Good Vigilance Practice)

Standards for post-marketing safety control of pharmaceuticals, quasi-drugs, cosmetics, and medical devices.

In vitro

Experiments conducted outside a living organism, such as in test tubes or culture containers using cells or tissues.

In vivo

Experiments conducted within a living organism.

Monitor

An individual appointed by a clinical trial sponsor (pharmaceutical company) to communicate with medical institutions during the conduct of a clinical trial.

MR (Medical Representatives)

Medical representatives who visit healthcare professionals to collect and provide safety-related information and support the proper use of pharmaceuticals.

NDA (New Drug Application)

A new drug application submitted in the United States.

Orphan Drug

A pharmaceutical designated by the Minister of Health, Labour and Welfare for treating rare diseases affecting fewer than 50,000 patients annually in Japan and recognized as having particularly high medical value requiring development.

OTC (Over-the-Counter Drug)

Non-prescription drugs.

Phase 1 Study

Conducted with a small number of healthy volunteers who provide consent, mainly to evaluate safety.

Phase 2 Study

Conducted with a small number of consenting patients to assess effective and safe dosage levels and administration methods.

Phase 3 Study

Conducted with a larger number of consenting patients, often using double-blind trials, to compare the safety and efficacy of a new drug with existing therapies.

Pharmaceutical and Medical Device Act

The Japanese law that regulates the manufacturing, distribution, storage, labeling, and handling of pharmaceuticals, quasi-drugs, cosmetics, medical devices, and regenerative medicine products to ensure quality, proper use, and strict control.

Placebo

A substance that contains no active ingredients but is indistinguishable from the investigational drug in appearance or taste.

POC (Proof of Concept)

Verification in humans that expected characteristics regarding efficacy or side effects are observed.

Post-marketing Surveillance

Surveys and post-marketing clinical trials conducted by pharmaceutical marketing authorization holders or foreign manufacturers to collect and verify information on the quality, efficacy, and safety of pharmaceuticals.

Promotion Code

A code that clearly outlines the conduct pharmaceutical companies must strictly follow when carrying out promotional activities.

Unmet Medical Needs

Medical needs that remain unfulfilled, meaning areas where no effective treatment methods currently exist.

Drug Price Standards

The "drug prices" established by public notice from the Minister of Health, Labour and Welfare. These function as both a list specifying which pharmaceuticals may be used under the national health insurance system and a price list determining reimbursement amounts.