Isofol´s Glossary
The following explanations are helpful in understanding certain specific terms and expressions that Isofol uses:
| [6R]-MTHF | [6R]-5,10-metylentetrahydrofolat |
| BfArM | The Federal Institute for Drugs and Medical Devices in Germany (Bundesinstitut für Arzneimittel und Medizinprodukte, BfArM) |
| CMC | Chemistry, Manufacturing and Controls |
| CRC | Colorectal Cancer |
| EMA | European Medicines Agency |
| FDA | U.S. Food and Drug Administration |
| iDSMB | Independant Data Safety Monitoring Board |
| ORR | Objective Response Rate |
| OS | Overall Survival |
| PFS | Progression Free Survival |
| PMDA | Pharmaceuticals and Medical Devices Agency |
Study phases
Preclinical study
Research that takes place before a drug or treatment method is sufficiently documented to be studied in humans. Includes testing of substances on tissue samples and subsequent testing on laboratory animals.
Clinical study/trial
Investigation of a new drug or treatment method on healthy volunteers or patients where the aim is to study the efficacy and safety of an as yet unapproved form of treatment.
Clinical phase l
The first time when a new substance is given to humans. Phase I studies are often carried out on a small number of healthy volunteers to study safety and dosage for an as yet unapproved form of treatment.
Clinical phase ll
Phase ll refers to the first time when a drug under development is given to patients to study the safety, dosage and efficacy of an as yet unapproved form of treatment.
Clinical phase lll
Phase lll studies/trials comprise numerous patients and are often conducted over an extended period of time. They are intended to map the efficacy and side effects of the drug under ordinary but still closely monitored conditions.
Pivotal study
A clinical study designed to provide data on the efficacy and safety of the drug when applying for market approval from the FDA or EMA, for example.
Phase IV study
A Phase IV study, also referred to as a postmarketing surveillance trial or drug surveillance, is intended to ensure the drug’s long-term safety and efficacy.
Last updated 06-01-2025
