Friday, 29 March 2024, 11:43 AM
Site: EUPATI Open Classroom
Course: EUPATI Open Classroom (EUPATI Open Classroom)
Glossary: Glossary
D

Dosage forms

Dosage forms of a medicine are the means (or the form) by which drug molecules are delivered to sites of action within the body. There are several types of dosage form, depending on the method/route of delivery of the medicine. These include for instance pills, capsules, syrups, suppositories and solutions for injection. Typically this involves a mixture of the active substance(s) and non-active substances (excipients).

Dosage regimen

The dosage regimen is the schedule of doses of a medicine, including the time between doses, the duration of treatment and the amount to be taken each time. Dosage regimens also include how a medicine is to be taken, and in what formulation (dosage form).

Dose

A dose is a single, measured amount of a medicine to be taken at one time. This can be expressed as the forms (e.g. 1 capsule, 1 suppository), weight (e.g. 250 mg), volume (e.g. 10 mL, 2 drops), or some other quantity (e.g. 2 puffs).

Dose-Range Finding

Dose-Range Finding

Dose-ranging

In a dose-ranging study different doses of a medicine are tested against each other to establish which dose works best and/or is least harmful.

Double blind

Double blinding is a method used in clinical trials to reduce the risk of bias, which can be caused intentionally or unintentionally when trial participants and/or researchers are aware of which participants are receiving which treatment (or placebo).

For example, in a trial with one treatment group and one placebo group, blinding means that the participants do not know which group they have been assigned to. In a double blind trial, neither the research team nor the participants know which participant is assigned to which group.

Sometimes the term 'single blind' is used to describe studies in which the participants are unaware of which group they are in but the research time is aware.

Drug candidate

In medicines development, the drug candidate is the molecule among several that has been shown to have sufficient target selectivity and potency, and favourable medicine-like properties and justifies further development. It will then be subjected to a new series of tests, and non-clinical studies and clinical trials. At this stage it is not yet a medicine.

Drug development

Drug development is the process of bringing a new medicine to the market once a drug candidate (lead compound) has been identified in drug discovery. It includes non-clinical tests on microorganisms and animals, application to the regulatory authority to initiate clinical trials on humans, and may include the step of obtaining regulatory approval with a Marketing Authorisation Application to market the drug. It is also known as medicines development. EUPATI uses the term medicines development throughout its texts.

Drug distribution

The process by which a medicine is distributed from one location to another within the body. See also pharmacokinetics.

Drug substance

An ingredient intended to exert pharmacologic action or other direct effect in the diagnosis, cure, mitigation, or prevention of disease or to affect any function of the body. Along with other ingredients (excipients,) it is used to formulate a medicinal product.