Glossary

index

Basic technology research: Basic technology includes drug delivery systems (DDSs) to control pharmacokinetics, and non-conventional new production technology. These technologies will lead to new products for patients.
Bioprocess technology: Bioprocess technology is a manufacturing technology where the natural biological activities of organisms or biological phenomena such as microorganisms, cells, and enzymes are integrated into the production of medicines.

Formulation: A pharmaceutical product that is processed into an easy-to-use form by blending additives, etc. to the active ingredients.
Formulation development research: Formulation development research is conducted from several standpoints. A particular formulation (injection, tablet, patch, etc.) is designed with the patients and their medical needs in mind. Also considered are the clinical requirements, to bring out the full potential of the compound. Once a formulation is developed, the methods needed to allow stable commercial production are studied. Furthermore, packaging that ensures product quality is maintained up until the expiry data is selected. The packaging must also meet the needs of clinical practice.

Industrialization research: The manufacturing method that can best ensure the safe, stable production of safe, high-quality drugs in actual production facilities is selected, while also responding to environmental considerations.
in vitro: Refers to testing with which an environment similar to that inside the living body is created in a test tube or culture dish using human or animal tissues and cells and the reaction against the drug inside the test tube or culture dish is detected.
in vivo: Refers to testing with which the test subject substance is administered directly in the living body of a test animal, such as a mouse, and the reaction against the drug inside the living body or cell is detected.

Manufacturing process design: Manufacturing methods leading to stable commercial production are studied while solving various problems that would occur following an increase in manufacturing scale.
Manufacturing/Supply/quality management of investigational new drugs: For use in clinical trial studies, a reliable investigational new drug is developed under sufficient management of manufacturing facilities and processes.

New drug application: To obtain approval for manufacture and sale as a pharmaceutical product, we compile application materials based on scientifically considered data and respond to inquiries from the authorities.

Omics: Exhaustive collection/analysis of various kinds of molecular information such as comprehensive gene expression information (transcriptome), the entire set of intracellular proteins (proteome) or the entire set of metabolic substances (metabolome).

Physical properties research: Before developing a compound that can be the "seed" of a pharmaceutical product, its basic information is investigated from the viewpoint of physicochemical and biopharmaceutical properties.
POC (Proof Of Concept): Confirmation of the expected characteristics, such as effects and side effects, with the human being. It is at the point of POC that the judgment is made on whether the drug candidate is worth development.
Product Life Cycle Management (PLCM): PLCM research aims to respond to a wide range of patient needs and the requirements of healthcare professionals. It includes improving ease in handling, palatability, and making patient compliance and adherence easier.

Quality and stability evaluation research: This is research conducted with the goal of providing high-quality pharmaceuticals of guaranteed efficacy and safety so that patients can take them feeling reassured.

Route scouting: The synthesis method, enabling efficient supply of the investigational drug with optimum quality, is designed by also considering commercial production in the future.

Tumor microenvironment: The microenvironment formed around a tumor and surrounding host-derived cells is related to tumor pathology, and significantly influences prognosis, sensitivity and resistance to treatment.