Toxicological test results.
Clinical, toxicological and pharmacological trials of DDP administration first, followed by DXR, are warranted.
Systems biology offers the means for understanding the limits of translatability of animal models in different settings, from clinical trials to toxicological assessments to basic cell biology.
Nevertheless, clinical trials and toxicological studies are needed to assess if this preparation can be regarded as potentially useful in this species.
Before any medicinal product is authorised for use in adults, it must undergo extensive pharmaceutical consistency and stability tests, toxicological tests and clinical trials to ensure that it is of high quality, safe and effective.
New ingredients must be approved by KFDA and are required to have sufficient toxicological and human clinical trial data supporting the safety and efficacy of the recommended daily dosage.
Nevertheless and although no adverse gastrointestinal reactions (diarrhea, colic, abdominal discomfort) were observed in any of the horses used in this trial, multiple dose, tissue distribution and toxicological studies are needed before clinical trials are set, to assess if this preparation can be regarded as potentially useful in this species.
Based on the fact that most of the measured values for the individual parameters were within the range described in control animals of the same strain and age, the genetic background of the plants seems not to influence the outcome of the feeding trials from a toxicological point of view.
Extensive preclinical pharmacological and toxicological studies prior to clinical trial are essential, not only to gain a thorough understanding of the compounds pharmacology but also to aid in the difficult decision of which starting dose to use in the patient.
The findings of our study complement the theme of 3Rs, providing promising and time-saving alternatives to animal trials in evaluating different toxicological endpoints for newly synthesized chemical structures.
