The International Conference on Harmonisation of Technical Requirements for Registration ofPharmaceuticalsfor Human Use; a project bringing together the regulatory authorities of Europe, Japan, and the United States with experts from the pharmaceutical
industry to discuss scientific and technical aspects of product registration. Its purpose is to recommend ways to harmonize
the technical guidelines and requirements for product registration and reduce or obviate the need to duplicate testing during
development of new medicines.
System A database search strategy for LC/MSE data. LC/MSE is a parallel unbiased approach to data acquisition that increases both the number of peptides and also the reproducibility
of the peptides sampled during an LC/MS experiment. The database search algorithm is for the qualitative identification of
data originating from LC/MSE data, whereby multiple precursor ions are fragmented simultaneously. Properties that are used by the algorithm include retention
time, precursor and product ion intensities, charge state, as crucially the accurate masses of both the precursor and product
ions form the LC/MSE data.
Ion-exchange chromatography; sometimes abbreviated IEX, a liquid chromatographic technique based on the electrical phenomenon of ion exchange. The amphoteric
nature of proteins can be exploited to bind them in cation-exchange (binding positively charged proteins) or anion-exchange
(binding negatively charged proteins).
Isoelectricfocusing; analytical separations in an electrical field through a pH gradient (therefore based on the net charge of the molecules);
usually done in bioanalysis at a neutral pH so that proteins (for example) will move under the influence of the electric field
until their net charge is zero (their isoelectric point, pI). IEF is a specialized form of electrophoresis that can be adapted
to the capillary format.
Isoleucine; one of more than 20 naturally occurring amino acids.
immortalize To alter cells (either chemically or genetically) so that they can reproduce indefinitely.
immunoassay An antibody-based test used most often for bioanalytical purposes.
immunodetection A process that identifies and quantifies specific biological substances, such as antigens.
immunogen A substance that provokes an immune response—that is, the body recognizes it as a foreign agent that must be expelled or destroyed.
immunoglobulin A protein produced by plasma cells that fights infection or takes part in various immune responses. Immunoglobulins bind with
other molecules with a high degree of specificity; divided into five classes (IgM, IgG, IgA, IgD, and IgE) on the basis of
structure and biological activity.
immunohistochemistry The staining of histology preparations using chromagen linked antibodies to specifically stain for specific proteins in a
impurity A foreign agent or material either introduced as part of processing (such as buffers or salts added during chromatography)
or intrinsic to the nature of bioprocessing (such as product variants and cellular debris).
Studies done "in the computer." Modeling a protein in silico refers to providing an integrated, computerized view of the molecule.
Performed using laboratory apparatus rather than a living animal.
Involving living animals or humans as test subjects.
Insulin, a hormone, was the first biopharmaceutical approved by the FDA.
inclusion bodies Discrete structures (virions, viral components, cellular material, aggregated proteins) present either normally or abnormally
Investigational New Drug application; process by which a company files a request with FDA for permission to expose its experimental drug to patients or healthy
human volunteers. This application must be filed for each individual clinical study performed, Phases 1 to 3.
indications A collection of symptoms or one disease type; the condition that a drug is intended to treat. The condition or symptoms a
particular drug is used to treat are determined either by evidence of positive effect or knowledge of the cause of the disease.
infusion Introducing a solution into the bloodstream or another solution; also refers to the solution itself, such as a drug formulation,
inoculate To introduce cells into a culture medium; also to introduce material to sensitize patients (as in vaccination).