Integrity test

Tests carried out to verify and assure the quality and readiness of the filter membrane regarding the regulatory requirements.

Intention-to-Treat (ITT) Analysis

Method for analyzing results in a prospective randomized study where all participants who are randomized are included in the statistical analysis and analyzed according to the group they were originally assigned, regardless of what treatment (if any) they received.


A type of bowel blockage that happens when one portion of the bowel slides into the adjacent one, much like the pieces of a telescope; it is treated in a hospital and may require surgery.

Interaction (Qualitative & Quantitative)

Situations where the difference in treatment effects is influenced by factors other than the drug under study. For example, it describes situations where the difference in treatment effects between the treatment group and the control group varies depending on each center.

Investigational Device

Device that is subject of a clinical study designed to evaluate the effectiveness and/or safety of the device.

Interim Analysis

Analysis of data that is conducted before data collection has been completed.

Investigational New Drug (IND)

Request for authorization from the Food and Drug Administration (FDA) to administer an investigational drug or biological product to humans. The drug undergoes clinical trials in humans after confirming its efficacy in animal experiments.


Substances produced during the API manufacturing process that require additional molecular changes or refinement before becoming APIs.

Investigational Product

Preventative (vaccine), a therapeutic (drug or biologic), device, diagnostic, or palliative used in a clinical trial.

Intermediate Precision

A measure of precision under a defined set of conditions: same measurement procedure, same measuring system, same location, and replicate measurements on the same or similar objects over an extended period of time.

Investigational vaccine

A vaccine that has been approved by the Food and Drug Administration (FDA) for use in clinical trials on humans. However, because investigational vaccines are still in testing and under evaluation, they are not licensed for use in the general public.

Intermediate product

Partly processed product that must undergo further manufacturing steps before it becomes a bulk product.


The person responsible for the conduct of the clinical trial at a trial site.

Intermediate Test

In the case of room temperature storage pharmaceuticals, the test conducted under intermediate conditions when there is a significant change in the accelerated test.

Isotype switching

A biological mechanism that changes a B cell’s production of immunoglobulin from one type to another, such as from the isotype IgM to the isotype IgG.

Internal pilot study

A phase in a trial after which progress is assessed against pre-specified targets. It gives an opportunity to stop trials which are not likely to reach their targets by estimating nuisance parameters.

Institutional Review Board (IRB)

An independent review board / committee (institutional, regional, national or supranational) whose main task is the protection of human research subjects and to provide public assurance of that protection.

Internal Validity

The extent to which the observed results represent the truth in the population we are studying and, thus, are not due to methodological errors.

Interactive Voice Response System (IVRS)

An automated phone system technology that allows incoming callers to access information via a voice response system of pre-recorded messages without having to speak to an agent. It allows participants to interact with the trial’s database including adverse events, patient management, documentation and reporting, etc.

International Conference on Harmonization

A common guideline created through continuous discussions between companies and government regulatory agencies in the United States, Europe, and Japan since 1990 to aim for drug approval based on the same criteria worldwide, in order to address unnecessary repetition of clinical trials and waste of time in the import and export of pharmaceuticals due to different regulations on clinical trials and drug approval in each country.

Inspection Order

Order created to track activities involved in inspecting items in or coming into Inventory.

Installation Qualification(IQ)

Documented verification that ensures the installation of any necessary equipment, piping, services, or instrumentation has been executed in accordance with the manufacturer’s requirements.

International Unit (IU)

An International Unit is the amount of a substance that has a certain biological effect. Measure of an activity not physical quantity.

Institutional Review Board

Peer-review body that is responsible for ensuring that research at the Institute safeguards the rights of human research subjects.

Immune system

The complex system in the body responsible for fighting disease. Its primary function is to identify foreign substances in the body (bacteria, viruses, fungi, or parasites) and develop a defense against them. This defense is known as the immune response. It involves production of protein molecules called antibodies to eliminate foreign organisms from the body.

Indirect Comparison

A method used when evidence from direct comparative clinical trials is lacking or insufficient, whereby data from separate studies are used to compare different healthcare interventions.


Protection against a disease. There are two types of immunity, passive and active. Immunity is indicated by the presence of antibodies or other components in the blood and can usually be determined with a laboratory test. See active and passive immunity.

In Vitro Transcription

A simple procedure that allows for template-directed synthesis of RNA molecules of any sequence from short oligonucleotides to those of several kilobases in μg to mg quantities.

Indirect protection / Herd protection

A form of indirect protection which occurs when a sufficient percentage of a population has become immune to an infection, whether through previous infections or vaccination, thereby reducing the likelihood of infection for individuals who lack immunity.


The process of being made immune or resistant to an infectious disease, typically by the administration of a vaccine. It implies that a vaccine will trigger an immune response.


Capable of spreading from one person to another or from one living being to another, communicable.


Ability of a foreign substance, such as an antigen, to provoke an immune response in the body of a human or other animal. Wanted immunogenicity typically relates to vaccines, where the injection of an antigen (the vaccine) provokes an immune response against the pathogen, protecting the organism from future exposure.


The process where a company (the licensee) acquires the rights to a product, technology, or intellectual property from another organization (the licensor).


Substances made by the immune system that attack foreign substances. Also known as antibodies.

In-process control

Checks performed during production in order to monitor and, if necessary, to adjust the process to ensure that the product conforms to its specifications. The control of the environment or equipment may also be regarded as a part of in-process control.


Living organism response, including redness, swelling, heat, and pain, resulting from injury, usually infectious, to tissue.


A complete antigen which is composed of the macromolecular carrier and epitopes (determinants) that can induce immune response.


Gradual deterioration of the immune system, brought on by natural age advancement.

Inflammatory Bowel Disease (IBD)

A general term for a constellation of symptoms associated with inflammation of the bowel. Examples include ulcerative colitis and Crohn’s disease. Symptoms include abdominal pain, diarrhea, fever, loss of appetite, and weight loss.

Independent Data-Monitoring Committee

Committee established to monitor the safety of participants in a clinical trial has, as its primary purpose, the protection of participants in the trial and the maintenance of the integrity of the trial.


The process of identifying proteins in tissue sections by incubating the sample with antibodies specific to the protein of interest, then visualizing the bound antibody using a chromogen (immunohistochemistry or IHC) or fluorescence (immunofluorescence or IF).

Inactivated vaccine

A vaccine made from viruses and bacteria that have been killed through physical or chemical processes, or contain parts proteins of the infectious agents. These killed organisms cannot cause disease.


A contagious with epidemic potential viral disease caused by Influenza virus, characterized by fever, prostration, muscular aches and pains, and inflammation of the respiratory tract.

Informed Consent

Process in which a health care provider educates a patient about the risks, benefits, and alternatives of a given procedure or intervention.


A condition in which the immune system is unable to protect the body from disease. This condition can be caused by diseases such as HIV infection or cancer or by certain drugs, such as steroids or those used in chemotherapy. Individuals whose immune systems are compromised should not receive live, attenuated vaccines.


Removal or reduction to an acceptable limit of infectivity of microorganisms or detoxification of toxins by chemical or physical modification.


Something that enters into a compound or is a component part of any combination or mixture.

Infrared Ray (IR)

A region of the electromagnetic radiation spectrum where wavelengths range from about 700 nanometers (nm) to 1 millimeter (mm).


Adverse effects on the functioning of the immune system that result from exposure to chemical substances.

Inactive ingredient

Components of a drug product that do not increase or affect the therapeutic action of the active ingredient.

Inhibition Constant (Ki)

A type of equilibrium dissociation constant (Kd) that represents the equilibrium binding affinity for a ligand that reduces the activity of its binding partner.

Immunotoxicity Study

The study of the toxicity of foreign substances called xenobiotics and their effects on the immune system.

Inapparent infection

The presence of infection without symptoms. Also known as subclinical or asymptomatic infection.


The act of putting a liquid, especially a drug, into a person’s body using a needle and a syringe.

Impartial Witness

A person who is independent of the trial and cannot be unduly influenced by the people involved with the trial and who attends the informed consent process if the participant or the participant’s LAR cannot read and who reads the ICF and any other written information supplied to the participant.


The ratio of new disease cases per population at risk reported over a given period.

Innate immunity

A type of immunity that is present at birth and lasts a person’s entire life. It enables the body’s rapid, nonspecific response to bacteria or virus. Anatomical barriers such as skin, acute inflammatory reaction initiated by macrophages and mast cells, complement system comprises the innate immunity in human.

Important Safety Information (ISI)

The summary of risks in a prescription drug print advertisement. It typically contains the name of the drug, FDA-approved uses for the drug, and the risks and side effects of the drug.

Included Terms

The lowest-level term used to code various different terms researchers use to describe drug side effects.


The action of immunizing someone against a disease by introducing infective material, microorganisms, or vaccine into the body.


Undesirable components present in intermediates or active pharmaceutical ingredients (APIs).

Inclusion Criteria

Characteristics that qualify prospective subjects to inclusion in the study.


The act by a regulatory authority(ies) of conducting an official review of documents, facilities, records, and any other resources that are deemed by the authority(ies) to be related to the clinical trial or commercial manufacturing location and that may be located at the site of the trial, at the sponsor’s and/or contract research organization’s (CRO’s) facilities, or at other establishments deemed appropriate by the authority(ies).

Impurity Profile

Any undesirable components present in intermediates or active pharmaceutical ingredients (APIs).

Incubation period

The time from contact with an infectious agent to onset of disease.

Independent Ethics Committee (IEC)

An independent review board / committee (institutional, regional, national or supranational) whose main task is the protection of human research subjects and to provide public assurance of that protection.

Immune Response

The way the body defends itself against substances it sees as harmful or foreign.

In Vitro Diagnostic Product

A reagent used to detect or measure substances in a sample derived from the human body in order to determine the presence of disease or infection.


A condition which makes a particular treatment or procedure advisable.


In biology, identification is the process of assigning a pre-existing taxon name to an individual organism.

Idiosyncratic response

Drug reactions that occur rarely and unpredictably amongst the population. This response is not dose-dependent nor concentration-dependent, thus different from adverse drug reaction due to overdose. The proposed mechanism of most idiosyncratic drug reactions is immune-mediated toxicity.