TACT glossary

Adverse Effect Levels (NOAEL) No Observable Adverse Effect Levels.
Assay A way to measure how many parts of a certain ingredient are in a larger system, object or mixture.
Biochemical The chemical reactions and make-up of the living cells of organisms.
Biodistribution This is a method of tracking where compounds of interest travel in an experimental animal or human subject.
Biological Mechanism In biology, a mechanism is part of an answer to a question about why some object or process occurred. Thus mechanism refers back from the object or process, along some chain of causation.
Biological Target This is a biopolymer such as a protein or nucleic acid whose activity can be modified by an external stimulus.
Biomarker A biochemical or a substance in the body that can be used to measure disease activity or effects of treatment.
Blind Trial This is a clinical trial where participants are unaware whether they are taking the experimental drug, placebo or standard treatment.
Breaking Blind When the treatment a clinical trial participant is taking is made known.
Cardiovascular Relating to heart and blood vessels.
Cellular Made up of cells.
Class Effects Class effect is usually taken to mean similar therapeutic effects and similar adverse effects, both in nature and extent.
Clinical Trials Clinical trials (also called medical research and research studies) are used to determine whether new drugs or treatments are both safe and effective.
Corticosteroids Any of the steroid hormones made by the cortex (outer layer) of the adrenal gland. Cortisol is a corticosteroid.
Crystallinity Crystallinity refers to the degree of structural order in a solid.
Data Safe Monitoring Board DSMB An independent committee, composed of community representatives and clinical research experts, that reviews data while a clinical trial is in progress to ensure that participants are not exposed to undue risk. A DSMB may recommend that a trial be stopped if there are safety concerns or if the trial objectives have been achieved.
Drug

A drug is defined as:

  • A substance recognized by an official pharmacopoeia or formulary.
  • A substance intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease.
  • A substance (other than food) intended to affect the structure or any function of the body.
  • A substance intended for use as a component of of a medicine but not a device or a component, part or accessory of a device.
  • Biological products are included within this definition and are generally covered by the same laws and regulations, but differences exist regarding their manufacturing processes (chemical process versus biological process.)
Drug Interactions A drug interaction is a situation in which a substance affects the activity of a drug, i.e. the effects are increased or decreased, or they produce a new effect that neither produces on its own.
Efficacy The efficiency and effectiveness of a drug to produce desired results.
Endpoint An endpoint is a mark of termination or completion.
Exclusion Criteria Exclusion criteria are the standards used to determine whether a person may or may not be allowed to participate in a clinical trial.
Formulation A prescribed recipe for making a drug.
Genotoxity Genotoxicity describes a deleterious action on a cell's genetic material affecting its integrity.
GMP Process The methods and controls used to assure appropriate quality and regulatory requirements are met in the manufacture, testing, holding, handling, or use of materials or products.
Immunogenicity The ability of a substance to provoke an immune response or the degree to which it provokes a response.
Inclusion Criteria Inclusion criteria are a set of conditions that must be met in order to participate in a clinical trial. In other words - the standards used to determine whether a person may be allowed to participate in a clinical trial.
License The legal authority or formal permission from authorities to carry on certain activities which by law or regulation require such permission.
Maximum Tolerated Dose The highest dose of a drug or treatment that does not cause unacceptable side effects.
Model Represents a living system used in research.
Off-target Pharmacology Adverse effects resulting from interaction of a drug with targets other than intended therapeutic targets.
Orphan Drug A drug specifically developed to treat a rare (orphan) medical condition.
Patent A device giving exclusive control and possession.
Pharmacodynamic Marker A specific indicator in a study of what a drug does to the body.
Pharmokinetics The processes (in a living organism) of absorption, distribution, metabolism, and excretion of a drug or vaccine.
Preclinical Refers to the testing of experimental drugs in the test tube or in animals - the testing that occurs before trials in humans may be carried out.
Primary Endpoint The main result that is measured at the end of a study to see if a given treatment worked.
Red Flags A warning signal.
Secondary Endpoint Secondary goal of a clinical trial.
Standard Operating Procedures Detailed, written instructions to achieve uniformity of the performance of a specific function.
Toxicology The scientific study of poisons.
   
 
07 Mar 2011