The following explanations are helpful in understanding certain specific terms and expressions that Isofol uses:
|EMA||European Medicines Agency|
|FDA||Food and Drug Administration|
|HDMTX||High-dose treatment with methotrexate|
|IND||Investigational New Drug Application (for the FDA)|
|NDA||New Drug Application|
|ORR||Objective Response Rate|
|PFS||Progression Free Survival|
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.
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 III 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 (study forming the basis for a decision)
A clinical study designed to provide data on the efficacy and safety of the drug when applying for marketing authorisation from the FDA or EMA, for example.