Dose

A quantity of a medicine or drug taken or recommended to be taken at a particular time.

Dose Regimen

The schedule of doses of a medicine, including the time between doses, the duration of treatment and the amount to be taken each time.

Division

A taxonomic rank in biological classification that is used differently in zoology and in botany.

Dose-response

The relationship between the applied dose/concentration (the amount of a substance administered, purposely or inadvertently, to cultured cells, an animal, or a person) and the effect that is observed.

Dossier

A group of papers that contain detailed information about someone or something.

Double-Dummy

The use of two different placebos to achieve blinding when the treatments being compared in a study are obviously different; e.g. a tablet and an injection.

Drop-Out Rate

The proportion of study participants who dropped out during pre-trial, during the trial, or during follow-up observation periods compared to the total study population.

Dropout

Subjects in a clinical trial whose observation is discontinued due to reasons preventing continuation until the final visit required by the study protocol.

Drug interaction

A reaction between two (or more) drugs or between a drug and a food, beverage, or supplement.

Drug Master File (DMF)

A document containing complete information on an Active Pharmaceutical Ingredient (API) or finished drug dosage form. It provides confidential, detailed information about facilities, processes, or articles used in the manufacturing, processing, packaging, and storing of human drug products.

Disease burden

Impact of a health problem as measured by financial cost, mortality, morbidity, or other indicators.

Disease Mongering

The practice of widening the diagnostic boundaries of illnesses and aggressively promoting their public awareness in order to expand the markets for treatment.

Drug Product (DP)

The finished product of any drug that is available in the market and is ready to use.

Disinfection

A process of complete elimination of vegetative forms of microorganisms except the bacterial spores.

Drug Substance (DS)

The active pharmaceutical ingredient (API), the active drug chemical or biological substance in purified bulk form.

Disseminate

To scatter or spread widely throughout the body’s tissues or organs.

Drug Tolerance

Subjects’ reduced reaction to a drug following its repeated use.

Dissolution Test

A test which measures the extent and rate of solution formation from a dosage form, such as tablet, capsule, ointment, etc.

Distillation

The process of making a liquid stronger or purer by heating it until it changes to a gas and then cooling it so that it changes back into a liquid, or a liquid made by this process.

Dosage Form

Names of classifications indicating the types of pharmaceutical preparations by their form or characteristics.

DTaP vaccine

A vaccine against diphtheria (D), tetanus (T), and pertussis (aP). ‘a’ stands for ‘acellular’, meaning it contains only part of the pertussis bacteria instead of the whole bacteria.

Detectability

The ability to detect or determine the presence or fact of a hazardous element.

Detection Bias

A type of selection bias that results when one population is more likely to have the disease or condition detected than another because of increased testing, screening or surveillance in general.

Detection Limit

The lowest quantity or concentration of a component that can be reliably detected with a given analytical method.

Data

All original records and true copies of original records, including source data and metadata, and all subsequent transformations and reports of these data which are generated or recorded at the time of the GMP activity and which allow full and complete reconstruction and evaluation of the GMP activity. Data should be accurately recorded by permanent means at the time of the activity. Data may be contained in paper records (such as worksheets and logbooks), electronic records and audit trails, photographs, microfilm or microfiche, audio or video files or any other media whereby information related to GMP activities is recorded.

Diabetes

A chronic health condition in which the body is unable to produce insulin or the insulin itself does not properly break down sugar (glucose) in the blood. Symptoms include hunger, thirst, excessive urination, dehydration, and weight loss. The treatment of diabetes may require daily insulin injections or oral medications to increase insulin production or activity in the body. Complications can include heart disease, stroke, neuropathy, poor circulation leading to loss of limbs, hearing impairment, vision problems, and death.

Decision Analysis

A form of decision-making that involves identifying and assessing all aspects of a decision, and taking actions based on the decision that produces the most favorable outcome.

Decision Maker

A person with the authority and ability to make timely and appropriate quality risk management decisions.

Differentiation

The processes by which immature cells become mature cells with specific functions.

Declaration of Helsinki

Statement of ethical principles for medical research involving human subjects, including research on identifiable human material and data.

Diphtheria

An infection caused by the bacterium Corynebacterium diphtheriae. Most infections are asymptomatic or have a mild clinical course, but in some outbreaks, the mortality rate approaches 10%. Symptoms often develop gradually, beginning with a sore throat and fever. In severe cases, a grey or white patch develops in the throat, which can block the airway, and create a barking cough.

Deletion (Gene)

A mutation in which a part of a chromosome or a sequence of DNA is left out during DNA replication.

Discontinuation

Termination of participation in a clinical trial by a subject before all requirements outlined in the protocol are completed.

Deltoid

A muscle in the upper arm where shots are usually given.

Disease

Sickness, illness or loss of health.

Demyelinating disorders

A medical condition in which the myelin sheath is damaged. The myelin sheath surrounds nerves and facilitates the transmission of impulses to the brain. Damage to the myelin sheath results in muscle weakness, poor coordination, and possible paralysis. Examples of demyelinating disorders include Multiple Sclerosis (MS), optic neuritis, transverse neuritis, and Guillain-Barre Syndrome (GBS).

Denaturation

Proteins or nucleic acids lose the quaternary structure, tertiary structure, and secondary structure which is present in their native state, by application of some external stress or compound, such as a strong acid or base, a concentrated inorganic salt, an organic solvent (e.g., alcohol or chloroform), agitation and radiation, or heat.

Dendritic Cell

A special type of immune cell that is found in tissues, such as the skin, inner lining of the nose, lungs, stomach and intestines and boosts immune responses by showing antigens on its surface to other cells of the immune system.

Dengue fever

A mosquito-borne disease caused by dengue virus, prevalent in tropical and subtropical areas. If symptoms appear, these may include a high fever, headache, vomiting, muscle and joint pains, and a characteristic skin itching and skin rash.

Design Of Experiments (DOE)

A branch of applied statistics that deals with planning, conducting, analyzing, and interpreting controlled tests to evaluate the factors that control the value of a parameter or group of parameters.

Design Qualification (DQ)

Documented verification that the proposed design of the facilities, systems and equipment is suitable for the intended purpose, meeting regulatory and process needs.

Design space

The multidimensional combination and interaction of input variables and process parameters that have been demonstrated to provide assurance of quality.