Fixed-Effect Method

A statistical model in which the model parameters are fixed or non-random quantities. In case of clinical trials, the reason for heterogeneity among the included studies in a meta-analysis is explained by variability within each primary study.

Fluorescent Focus Assay / Focus Forming Assay (FFA)

A variation of the plaque assay, but instead of depending on cell lysis in order to detect plaque formation, the FFA employs immunostaining techniques using fluorescently labeled antibodies specific for a viral antigen to detect infected host cells and infectious virus particles before an actual plaque is formed. The FFA is particularly useful for quantifying classes of viruses that do not lyse the cell membranes.

Food and Drug Administration (FDA)

An agency in the U.S. federal government whose mission is to protect public health by making sure that food, cosmetics, and nutritional supplements are safe to use and truthfully labeled.

Formulation

Pharmaceutical formulation, in pharmaceutics, is the process in which different chemical substances, including the active drug, are combined to produce a final medicinal product. The word formulation is often used in a way that includes dosage form.

Full Analysis Set

The analysis set which is as complete as possible and as close as possible to the intention-to-treat ideal of including all randomized subjects.

Functional assay

Systematic experiments (either in vitro or in vivo) used to elucidate the function of a protein in a cellular pathway or biological process.

Functional Observation Battery (FOB)

A noninvasive procedure designed to detect gross functional deficits in young adults rats resulting from exposure to chemicals and to better quantify neurotoxic effects detected in other studies.

Functional Requirement

A summary or list of calculations, technical details, data manipulation and processing, and other specific functionality that define what a system is supposed to accomplish.

Functional Testing

A form of software system testing that verifies whether software matches its design.

Fast Track

A process designed to facilitate the development, and expedite the review of drugs to treat serious conditions and fill an unmet medical need.

Febrile seizure

A seizure associated with a high body temperature but without any serious underlying health issue.

Fermentation

Process that helps break down large organic molecules via the action of microorganisms into simpler ones.

Finished product

A finished dosage form that has undergone all stages of manufacture, including packaging in its final container and labelling.

First-In-Human trial (FIH trial)

The initial stage of clinical testing in which an experimental drug or treatment is administered to humans for the first time, typically after preclinical testing in laboratory and animal studies.