Toxicokinetics (TK) studies is generation of kinetic data for systemic exposure and toxicity assessment of the drug. These studies help us to estimate the observed toxicity to that dose. TK evaluation is very important in drug development phase in both regulatory and scientific perspective. There are several guidelines to conduct TK study in animals recommended by regulatory bodies (OECD). TK evaluation is useful in selection of dose, dosing form, alternative dosing route, evaluation of toxicological mechanism, and also used for the setting safe dose level in clinical phases. This TK studies also used to reduces the animal number (replacement, reduction and refinement). On the other hand, TK data are practically used for the purpose of drug discovery such as lead-optimization and candidate-selection.
We can perform your initial PK screening and evaluate different dose formulations. Your custom designed study can be conducted in mice, rats, rabbits, dogs, pigs, and non-human primates using virtually any route of administration. The PK/ADME group provides analytical support for our GLP-compliant toxicology, pharmacology, immunology and discovery service groups. We can develop or transfer analytical methods for dosing formulation analysis including test article concentration determination, homogeneity analysis and stability measurements. We can quantify your compound in biological matrices such as blood, plasma, serum, urine and tissues. All bioanalytical services are conducted according to the standards of FDA Good Laboratory Practice (GLP) and other relevant international regulatory guidelines.
LC/MS (Liquid Chromatography–Mass Spectrometry)
Our fully validated state-of-the-art GLP LC/MS technology provides quantitative analysis of chemicals with high sensitivity and selectivity. Test compounds can be detected at low levels in fluids (plasma, serum, and urine) and tissues.
Toxicokinetic Studies in Preclinical Stage:
Generally safety of a molecule can be performed in in-vivo systems. This step is not included in the guidelines but it is very useful for the researchers to assess the systemic exposure of the molecule and its effect on it.
Single Dose and Rising Dose Studies
These studies are often performed in a very early phase of drug development before a bioanalytical method has been developed.
Repeated-Dose Toxicity Studies
To give support for phase 1 studies, this study is carried out for four weeks in both rodents as well as non-rodents.
Two in vitro studies and one in vivo study is essential to support development of drug.
Reproduction Toxicity Studies
Reproduction toxicity measurements are taken in studies of fertility (rat), embryo-foetal development (rat and rabbit) and peri- or post-natal development (rat).
Studies of Fertility
Assessment of fertility toxicity has very important, because most of the drugs used in fertility conditions so has to strengthen at that time. Usually this can be done in rats.
In Pregnant and Lactating Animals
Toxicokinetics Studies Basics
Toxicokinetics studies take advantage of our state-of-the-art LC/MS technology that provides quantitative analysis of chemicals with high sensitivity and selectivity. Test compound concentrations can be detected in fluids and tissues depending on the needs of the study. Methods are validated with known test compounds to standardize extraction and detection of low-level chemical compounds in test materials.
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