Page 37 - New Employee Glossary

Glossary 37

Manufacturing facility with the capability of producing large amounts of product to be
distributed internationally. Biogen has an International Large Scale (ILS) Manufacturing
facility in Hillerod, Denmark.

Intramuscular (IM)

Administration of a substance directly into muscle e.g. AVONEX

Intravenous (IV)

Administration of a substance into veins

Investigational Medicinal Product (IMP)

A product being studied in a clinical trial

Investigational Medicinal Product Dossier (IMPD)

The summary of scientific data on product being used in a clinical study.

Investigational New Drug (IND)

Application process in which a sponsor must show it is feasible and safe to begin human
clinical trials with an investigational product

Investigational Product (IP)

Study drug, device, etc.

Investigator Initiated Trial (IIT)

Any clinical study conducted by a Sponsor-PI under his or her IND and supported by Biogen
through provision of study drug and/or funding.

Investigator Sponsored Trial (IST)

Any clinical study conducted by a Sponsor-PI under his or her IND and supported by Biogen
through provision of study drug and/or funding.

Investigator’s Brochure (IB)

A compilation of clinical and nonclinical data on the investigation product relevant to the
study of the investigational product in human subjects.

iProcurement