Toxicokinetic Studies | TK Studies

Toxicokinetics (TK) is a combination of pharmacokinetics and toxicology. Based on the principles and methods of pharmacokinetics, TK studies quantificationally discuss in vivo drug absorption, distribution, metabolism and excretion (ADME) under toxic doses in animals. Research of drug toxicity is helpful for understanding the drug target organs and provides the basis of drug clinical application and drug overdose diagnosis. Although increasing experiments are compliant with GLP standards to ensure the traceability of record and the reliability of results, some TK studies can’t compliant with complete GLP standards at early exploration stage. It is hard to be carried out in accordance with the established plan during the studies and there will always be a process of constantly adjusting. Therefore, GVK BIO provides exploratory non-GLP TK services involving several different strategies and depending on the scientific questions to be answered.

Toxicokinetic studies help us to estimate the observed toxicity to that dose. TK studies are 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). Evaluation of toxicokinetic studies 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. These TK studies also used to reduces the animal number (replacement, reduction and refinement). On the other hand, data from toxicokinetic studies 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 and beagle dogs using virtually any route of administration.  The PK/ADME group provides analytical support for our 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.  The bioanalytical services are conducted according to the standards of FDA Good Laboratory Practice (GLP) and other relevant international regulatory guidelines.

Our experience in TK studies covers every route of administration, type of toxicity study, and expertise in complex nonclinical study designs.  In addition, our clients have direct access to some of the most experienced toxicologists in the industry. Listed below are several of the services we offer:

  • Non-GLP TK analyses
  • Study design including dose selection, frequency and sample collections
  • Nonclinical protocol development
  • Rapid and thorough Quality Assurance team
  • Robust report templates

Here is the list of our toxicokinetic studies and bioanalysis:

TK Studies
  • Validation of concentration analysis in dosing solution
  • Dosing solution concentration measurement and stability study
  • Validation of drug concentration analysis in biological samples
  • Drug concentration analysis in biological samples
  • Validation of analytical procedures for content in drug substances and drug products, and related substances
  • Content measurement in drug substances and drug products, and stability studies
  • Uniformity of dosing solution, Absorption test (content measurement)
Bioanalysis
  • Measurement of test substances that are difficult to be analyzed by normal instruments such as antibodies and protein products
    Measurement of anti-drug antibody titers
  • Measurement of in vivo components that are difficult to be analyzed by normal clinical biochemistry such as cytokines, chemokines and enzymes.
  • Measurement of Food for Specified Health Uses composition in foods
  • Analysis of blood cell components by flow cytometer (FACS)
  • Evaluation of drug metabolic stability in vitro by microsomes from animals
  • Evaluation of serum protein binding rate of drug

Our non-GLP protocols for TK Studies are simplified with template of study designs and corresponding abbreviated report format. We focus on preliminary evaluation of key endpoints and use more streamlined designs. Our streamlined toxicokinetic processes mean less paperwork and more efficient data collection and review. We have flexible and dedicated toxicokinetic services staff to perform multiple functions resulting in simplified processes.

Serving as an extension of your team, our toxicokinetic studies team works with you to support the analysis of PK, toxicokinetics, PK/PD analysis data, providing insights to help solve the challenges encountered during development. Review cycles for protocol and report are reduced with preset study designs making outsourcing of your TK Studies easy.

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