Creative Biolabs performs all aspects of non-clinical pharmacokinetic (PK) and toxicokinetics (TK) evaluations in accordance with Good Laboratory Practice (GLP) procedures. We offer repeat dose toxicity studies to give support for clinical studies.
The purpose of repeat dose toxicity test is to characterize the adverse toxicological effects occurring as a result of repeated daily dosing. This study is an integral part of the data package produced to perform quantitative risk assessment (QRA). Our capabilities including the following:
Creative Biolabs offers several types of in vivo repeat dose toxicity assessments, which include:
Design of Individual Studies
The dose levels, the frequency and administration routes are based on available pharmacodynamic, pharmacokinetic, and toxicological data as well as the intended clinical use. The general design of our repeat dose toxicology studies include:
- Appearance, behavior, ambulation, cognition
- Growth, food consumption, neurological exam, water consumption
- Ophthalmoscopy, body temperature, blood pressure, and ECGs
We use various analytical methods to evaluate plasma (or whole blood or serum) concentrations of pharmaceuticals with adequate sensitivity and precision. Our validated analytical methods conform to Good Laboratory Practice (GLP). Methods used in such studies include:
Figure 1: Dose response curves to assess acute (black) and repeated dose (grey) toxicity of 6 chlorpromazine on a) 2D HepG2 cultures or b) 3D HepG2 cultures. (Mueller et al. 2014)
Creative Biolabs evaluates and reports all the data within a project in the same consistent way. With our extensive experience in toxicity study, we will provide you the best service of the repeated toxicity study.
For more detailed information, please feel free to contact us or directly sent us an inquiry.
For Research Use Only.