Glossary

The IMPD provides a summary of information on quality of the investigational medicinal product to be used in the clinical trial, including reference products and placebos. It also provides data from non-clinical studies and available previous clinical experience with the use of the investigational medicinal product. An overall risk-benefit assessment, critically analyzing the non-clinical and clinical data in relation to the potential risks and benefits of the proposed trial must also be included. A simplified IMPD may be submitted if information related to the investigational medicinal product has been assessed previously as part of a marketing authorization.Following implementation of the European Clinical Trials Directive (2001/20/EC) into national law of the European Member States, an IMPD is now required to accompany an application to perform clinical trials in any European Member State.

Before testing a new drug on human subjects, the company must file an IND. Prior to filing an IND, the sponsor develops information on the chemistry of the drug so that it can be produced in batches of known strength and purity. In addition, the sponsor must conduct a number of animal studies to produce information on the pharmacology and toxicology of the drug. Information, for example, must be produced on the absorption, distribution, metabolism, and excretion properties of the drug. Finally, detailed protocols for testing on human subjects must be submitted. In addition, since 1971, the FDA has required that all proposed clinical studies be reviewed by an institutional review board. Technically, unless otherwise notified, the sponsor can begin clinical studies within thirty days (if the IRB approves). The FDA can, however, terminate an IND at any time; thus in practice the FDA must approve the IND proposal. The IND stage of drug approval is broken into three phases. The FDA exerts considerable control over all phases of the clinical trial process, and at any stage the FDA can and often does request additional clinical trials and changes in trial protocols.

A new drug or biological drug that is used in a clinical investigation. The term also includes a biological product that is used In Vitro for diagnostic purposes. Investigational new drugs can be considered IMPs.

A pharmaceutical form of an active ingredient or placebo being tested or used as a reference in a clinical trial, including a product with a marketing authorization hen used or assembled (formulated or packaged) in a way different way from the approved form, or when used for an unapproved indication, or when used to gain further information about an approved use.

In clinical trials, an individual who actually conducts an investigation [21 CFR 312.3]. Any interventions (e.g., drugs) involved in the study are administered to subjects under the immediate direction of an investigator.

A person responsible for the conduct of the clinical trial at a trial site. If a trial is conducted by a team of individuals at a trial site, the investigator is the responsible leader of the team and may be called the principal investigator.

Relevant clinical and non-clinical data compiled on the investigational drug, biologic or device being studied

Not viscous.

A non-metallic chemical element, symbol I, atomic number 53, one of the micronutrients or “trace elements”, i.e., one essential to life in trace quantities.

Literally an “iodine-carrying” compound. An iodophor is a combination of iodine and a solubilizing surface-active agent, or carrier.

Indicative Occupational Exposure Limit Values

Institute of Occupational Medicine (United Kingdom)

An atom or radical in solution carrying an integral electric charge, either positive (cation) or negative (anion).

An atom or group of atoms carrying a charge of electricity and constituting one of the parts of an electrolyte. Ions charged with negative electricity which travel toward the positive pole (anode), are called anions, those charged with positive electricity which travel toward the negative pole (cathode), are called cations.

One of the processes used to further reduce the concentration of ions in water supplies referred to as total dissolved solids (TDS) removal. The process uses anion and cation exchange resin to chemically react with and remove the remaining ions or TDS in water. This process results in water in water with virtually no TDS.

The process by which ion exchange resin that can no longer effectively remove ions from the water is recharged. This recharging or regeneration is performed by adding caustic soda Sodium Hydroxide (NaOH) to the cation resin and either Hydrochloric Acid (HCl) or Sulfuric Acid (H2SO4) to the anion resin. These regenerant solutions are allowed to flow through the resin beds at specific flow rates and periods depending on the type of resin, the ionic load, and the final purity desired. Solutions react with the ion exchange resin releasing the removed cations and anions, which are then carried away to drain by the flow of the regenerant chemicals. The excess chemicals are rinsed from the ion exchange resin with purified water when the bed is ready for another service cycle.

A styrene-divynilbenzene or acrylic copolymer formed into small, spherical, and highly porous beads about the size of a pinhead. These inert beads are chemically treated so that they perform as if they were chemical compounds.

Attractions between oppositely charged chemical groups.

Introduction of drugs through intact skin using the transfer of ions by applying a direct electric current.

Intellectual Property

Internet Protocol

Investigational Product

Isopropyl Alcohol

Intergovernmental Panel on Climate Change

International Program on Chemical Safety