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Acceptable Daily Intake/Tolerable Daily Intake

Specification and Aims of ADI/TDI

Unlike the PDE (Permissible Daily Exposure), the ADI (acceptable daily intake) as well as the TDI (tolerable daily intake) consider oral intake only and represent estimates of the amount of a substance in air, food, or drinking water that can be taken daily over a lifetime without significant health risks. Therefore, these approaches might therefore be the better choice for oral-only pharmaceuticals or food related products. Additionally, the ADI / TDI approach may be applied to toxicologically qualify substances that can be present as a result of the manufacturing process or they can arise from natural or environmental sources.

 

Indicate Toxicity

The ADI concept can be understood as a measure to indicate the toxicity of long-term exposure to repeated ingestion of chemical compounds (present and/or added), as opposed to acute toxicity.
 

NOAEL-based approach

The No-Observed(-Adverse)-Effect Level, the amount of a substance that shows no toxic effects, is determined by performing studies with several doses including high doses. In several studies on different effects, the most relevant NOAEL is selected to form the basis of ADI-calculations.

Safety and Quality

The determination of an ADI is to verify the safety of an (orally administrable) compound and the provision of high quality pharmaceutical products.
 

 

UF

Uncertainty factor provides a margin of safety for allowable human exposure, derived from measurements regarding the reaction of the most sensitive animal species in order to estimate an NOAEL or a LOAEL for humans.

 

TTC

Improved analysis processes allow to detect substances in low or very low concentrations. Even though it may not be possible to generate toxicological data on each substance, it is of importance to evaluate these previously non-detectable trace substances. The TTC (Threshold of Toxicological Concern) concept has now been widely accepted to qualitatively evaluate risks possibly posed by these low-concentrated substances and is part of the important scientific process prioritising from chemical substances with low exposure for which further data is necessary to substances with no significant risk to human health.

 

LOAEL

Lowest-observed-adverse-effect Level is the lowest level of a chemical stressor evaluated in a toxicity test which shows harmful effects on a plant or animal. While LOAELs and LOAECs are similar, they are not interchangeable. A LOAEL refers to a dose of a chemical that is ingested.

IASON consulting is the partner of choice for the determination of ADI/TDI

As one of the most successful health science consultation providers on the market, our team of consultants has the experience and know-how to provide quick, reliable, and specific services with regard to ADI determination as well as any other pharmaceutical and/or biotechnological request. Please feel free to contact us to find out more about IASON consulting and our provided services throughout the health care industry at any given time.