Ask The Experts: GLP Toxicity Study Layouts And Assay Platforms To Expedite Clinical Development


Any drug goes through three different stages before being launched in the market. These steps include discovery, IND enabling studies and clinical trials. Experts use this process to find out the safety and suitability of a medicinal product before commercial production. The clinical toxicological analysis is a significant part of this procedure because it enables the development team to identify the adverse effects of a drug.


Here, we will explore some layouts and assay platforms of GLP toxicity study that push medicinal products' clinical development before they hit the market. It will enable you to understand the complete procedure of a non-GLP study.


GLP Toxicity Study Layouts

The process of clinical toxicological analysis begins with safety testing. At this stage, the drug's effects on different vital functions are evaluated. Subsequently, it proceeds to other investigations such as:

  • Toxicokinetics: Analysis of animal testing data
  • Single Dose Toxicity: For dosage range studies
  • Repeated Dose Toxicity: To check for repeated dose effects
  • Chronic Toxicity: Effects of prolonged exposure to the drug
  • Local Tolerance: Tolerance of the given drug on different sites in the body
  • Reproduction Toxicity: Effects on various reproductive subjects


These analyses help identify all possible adverse effects of the medicinal products before forwarding them for clinical trials.


GLP Toxicity Study Assay Platforms

The previous sections provided an overview of toxicity study in drug development. Let's find out some assay platforms of IND enabling studies. These assays for preclinical toxicity studies have been developed over the years to see the product's effects on different organs of the body. The process helps in avoiding any possible adverse effects in clinical trials. Some of them include:


  • Specific-Protein Assay: In this non-GLP study, it is checked whether the chemicals present in the drug inhibits specific enzymes or binds to some biomolecule or receptor. The process is beneficial to get the idea of the product's working at the molecular level. The preclinical toxicity studies provide relevant results even for high-throughput formats.


  • Cell-Based Phenotypic Assays: Though the previous method was efficient, it did have some limitations. Therefore, this toxicity study assay came into the picture. Phenotypic here refers to the physical properties of living organisms. Thus, this process uses cultured cells to measure the overall phenotypic output. Through this, experts seek acute toxicity predictions. This platform gets further divided into other assays depending on the requirements of drug analysis.


  • Organotypic: The only problem with the previous clinical toxicological analysis is that the single-cell doesn't provide accurate relevance with human tissues. The issue is dealt with new multiple-cell type models. This IND enabling studies procedure helps in exploring the acute toxicity of the given drug. Depending on the organ system involved, it can be further divided into different models.


Apart from these toxicity study assays, some other models can also be used for yielding better results. 



We hope all these details will help you understand how the non-GLP study expedites clinical development of a drug. However, it is a good idea to seek professional services for preclinical toxicity studies. Their methods are validated, which offer much better results through proper drug biomarker analysis.