Good Practices (GxP)

A group of good practice guides governing the preclinical, clinical, manufacturing, testing, storage, distribution and post-market activities for regulated pharmaceuticals, biologicals and medical devices, such as GLP, GCP, GMP, good pharmacovigilance practices (GVP) and good distribution practices (GDP).

Gowning Qualification

A program that establishes, both initially and on a periodic basis, the capability of an individual to don the complete sterile gown in an aseptic manner.

Granulator

Machine which makes particles bigger by moving them so that they stick together.

Group Sequential Design

Study design which the sample size of the trial is not fixed in advance, and data is sequentially evaluated as it is collected.

Guillain-Barre Syndrome (GBS)

A rare neurological disease characterized by loss of reflexes and temporary paralysis. Symptoms include weakness, numbness, tingling, and increased sensitivity that spreads over the body. Muscle paralysis starts in the feet and legs, then moves upwards to the arms and hands. Paralysis can affect the respiratory muscles and cause breathing difficulties. Symptoms usually appear over the course of one day and may continue to progress for 3–4 days and up to 3–4 weeks. Recovery begins within 2–4 weeks after the progression stops. While most patients recover, approximately 15%–20% experience persistent symptoms. GBS is fatal in 5% of cases.

Good Manufacturing Practice (GMP)

A system for ensuring that products are consistently produced and controlled according to quality standards. It is designed to minimize the risks involved in any pharmaceutical production that cannot be eliminated through testing the final product.

Gastroenteritis

An inflammation of the lining of the stomach and intestines.

Gene therapy

A medical technology that aims to produce a therapeutic effect through the manipulation of gene expression or through altering the biological properties of living cells.

Genome

Is all the genetic information of an organism. It consists of nucleotide sequences of DNA (or RNA in RNA viruses).

Gangrene

Death of body tissue due to a lack of blood flow or a serious bacterial infection.

Gene Therapeutic Drug

A pharmaceutical substance or medication containing genetic material, or including genetic material, administered into the body for purposes such as disease treatment.

Generalisation

The extent to which the findings of a study can be applied to other situations.

Generic Drug

A pharmaceutical drug that contains the same chemical substance as a drug that was originally protected by chemical patents.

Genetic Marker

A DNA sequence with a known physical location on a chromosome.

Genotoxicity

The property of chemical agents that damage the genetic information within a cell causing mutations, which may lead to cancer.

Global Assessment Variable

Single variable that integrates objective variables of a patient’s condition or its changes with the overall opinion of the researcher, typically represented by a ordinal categorical scale.

Gnawing

A sensation of dull, constant pain or suffering.

Good Clinical Practice (GCP)

International ethical and scientific quality standard for the design, conduct, performance, monitoring, auditing, recording, analyses and reporting of clinical trials.

Good Laboratory Practices (GLP)

A set of principles designed to guarantee the quality of nonclinical laboratory studies, ranging from in vitro studies to preclinical animal experiments. These principles ensure that nonclinical studies are planned and performed safely.