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Comprehensive Overview Of Toxicology Studies In Nonclinical Drug Development


Before drugs are made available for general consumers, the product has to go through several testing procedures. These analyses ensure that the drug is efficient and safe for the users. One of the most vital processes here is the toxicology studies in relation to drug development. The TK study helps identify the adverse effects of a product. It is done by evaluating the animal exposure results and finding risk factors for human subjects.

However, the concept of toxicology isn’t as straightforward as it seems. Therefore, you first need to explore all its aspects to understand it completely.

Toxicokinetic and Pharmacokinetic

In these GLP toxicology studies, ADME inspections are conducted on animal species for the given drug product. ADME refers to Absorption, Distribution, Metabolism, and Excretion. Through these analyses, the drug’s behavior gets evaluated when it is exposed to living organisms. The results then get examined to draw a pattern between the drug’s impact on animals and humans to understand its toxicity for humans. These tests are conducted before human trials so that to avoid any unfavorable circumstances.

Single Dose Toxicity

This IND study is crucial to find the upper bounds of exposure to the drug. These analyses get done on two mammalian species. Just like toxicokinetic, single-dose GLP tox studies are conducted before the human trials take place. It helps in ensuring that humans don’t get exposed to unsafe amounts of drugs.

Repeated Dose Toxicity

The principle states that animal toxicology studies’ duration in drug development should be equal to the human trial duration. However, this duration mostly depends on factors such as therapeutic indication and the proposed clinical trial scale. These analyses show that the drug is safe for multiple dosages when given at specific intervals. Thus, minimizing the risk factors for human trials.


Several drugs can cause mutations and chromosomal damage to human bodies. That is why these toxicology studies are conducted. These inspections help detect any positive signs to eliminate them early and make the product safe for human trials.

Reproduction Toxicity

Reproduction TK study is done uniquely according to the group where the drug has to be used. The four common categories here are:

  • Men
  • Women with no childbearing potential
  • Women with childbearing potential
  • Pregnant women

As all these people get differently affected by reproduction toxicity, conducting different examinations for each group is necessary. Usually, the second group doesn’t require these tests as their fertility doesn’t get affected by the drugs.

Local Tolerance

This GLP tox study may or may not be conducted separately. Here, the tolerance of the drug gets checked for different sites in the human body. It helps in ensuring that no organ or specific site will encounter any adverse effects from the product. Just like all others, this IND study also takes place before human trials.


We hope all these factors must have provided a comprehensive overview of the toxicology studies in drug development. However, you need to understand that these GLP toxicology studies can differ according to individual drug requirements. All drug manufacturers must abide by the FDA guidelines for smooth approval of the drug at later stages.