Glossary

Adverse event: Any adverse change in health such as a drug side effect or strained finger which may occur in a person who participates in a clinical trial while the subject is receiving the treatment (study medication, placebo, application of a medical device, etc.). An adverse event (whether caused by the drug or other unexpected incident) may also be an event which occurs within a specified time period after the study has been completed and therefore must be reported to regulatory agencies.

Bioavailability: The measurement of the extent to which a drug reaches the systemic circulation. It is calculated from the blood samples taken during the trial at different times. The value obtained could be used for a comparison between two formulations, for example.

Biochemistry tests: Analysis of bodily fluids for the determination of levels of sodium, potassium, chloride, bicarbonate, urea, creatinine, calcium, glucose, etc. The results will help determine if the participant can be selected for a specific clinical trial.

Bioequivalence: Term used in pharmacokinetics used to assess if two products can be considered equivalent in how they are absorbed and eliminated from a normal human body.

Blinded: Study where some participants involved are prevented from knowing certain information that might lead to conscious or unconscious bias on their part, invalidating the results.

BMI: The Body Mass Index is a number obtained from a calculation using the weight and height of a person. It is one of many criteria used to select a participant.

Dose: Quantity of medication administered.

Fast/Fed Studies: Clinical trials designed to determine under both fasted and fed conditions if food has any impact on if the drug is absorbed or how fast the drug is absorbed. These studies can either run as a single study or two separate studies.

Follow-up visit: Mandatory return visit to the clinical site after the participant has left, to perform additional blood draws or for medical supervision.

Formulation: The formulation of a drug refers to all the ingredient which create the tablet or capsule or ointment. For example, the ingredients may help the tablet break up in the stomach or make the ointment feel smooth on the skin.

  

Generic drug (generics): A generic drug has been created by a competing drug company and must fulfill all federal regulations which require it be absorbed and eliminated exactly like the original innovator product it was created to mimic. It can be no better and no worse than the original product.

Hematology tests: Required examination and measurement of the cells of blood, as well as blood clotting.

Informed Consent: A document the participant must read, understand and sign before enrolling in a study. This document informs the potential participant about the drug name, study activities, potential adverse events, sample collections (blood draws), and all related activities.

Opiate drugs: Derivatives of constituents found in opium, likemorphine, codeine, thebaine, and papaverine. Could also be semi-synthetic opioids such as heroin, oxycodone, and hydrocodone.

Phase I/IIa: Clinical trial at the first stage of testing in human subjects. Phase I is typically a small (20-100) group of healthy participants. Phase I includes trials designed to assess the safety (pharmacovigilance), tolerability, pharmacokinetics, and pharmacodynamics of a drug. Phase II is a continuation of this research but it involved patients with the disease under investigation.

Pilot study: Small scale preliminary study conducted before the main research in order to check the feasibility, or to improve, the design of the research. These pilot studies can also be called path finders. Typically, these types of studies are to confirm absorption of the medication before a full launch of a clinical trial.

Plasma: Yellow liquid component of blood in which the blood cells in whole blood are normally suspended. Blood plasma is prepared by spinning a tube of fresh blood containing an anti-coagulant in a centrifuge until the blood cells fall to the bottom of the tube.

Post-dose: Period after the drug has been taken.

Screening: Strategy used to select adequate individuals for a clinical study based on predetermined inclusion and exclusion criteria when assessing their health, age, weight and other research study criteria.

Serum: Plasma with the fibrinogens (glycoprotein responsible for coagulation) removed.

Side effect: See adverse event.

Urinalysis: Array of tests performed on urine.

Definitions adapted from Wikipedia.

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