In Vivo DMPK

Creating compounds with a profound pharmacokinetic profile can be challenging. With more than 20 years of drug metabolism and pharmacokinetics (DMPK) expertise, our interdisciplinary team of scientists and lab professionals can identify relevant drug metabolism and pharmacokinetic liabilities for you. Multiple assay types and in vivo models deliver all of the data needed for your compound optimization and clinical candidate selection.

In vivo DMPK compiles the pharmacokinetic (PK) profile of your compound. We can apply different methods of application to your in vivo model and measure plasma and tissue levels of the test compound. Analysis of the samples will be performed by LC-MS/MS or HPLC-UV in our discovery bioanalysis group. Depending on your compound profile and needs, our capabilities offer various study designs. We can perform a data analysis, such as non-compartmental analysis of your compound. This includes the determination of parameters, including clearance, elimination half-life, Tmax, Cmax, and the bioavailability of your compound, and can be performed with Phoenix WinNonlinTM. To calculate blood clearance, a blood-to-plasma ratio assay is available in-house. More detailed studies examine the distribution in target tissues, the crossing of physiological borders such as the blood/brain barrier, and the excretion of the compound. Data and reports can be provided via Phoenix WinNonlinTM; in Microsoft® Excel, Word, or PowerPoint following our standards; or they can be adjusted to your specific needs.

We perform high-quality PK studies in mice, rats, dogs and mini pigs. Microsampling enables generation of a full plasma-time concentration profile from one animal while maintaining highest animal welfare standards. Depending on your requirements, you can choose between naïve or catheterized animals. We offer all standard administration routes, including iv (bolus or infusion), po, sc, and others. We are open to address your special research questions.

Dosing of compounds is possible as a single compound or in cassette dosing (up to four compounds plus a reference). Tailor-made studies for specific absorption, distribution, metabolism, and excretion (ADME) questions can also be provided:

  • Tissue distribution studies (cold compound) from the same animal
  • Bile duct-cannulated rats and compound administration via portal vein infusion
  • Metabolic cage studies to investigate further excretion pathways
  • Studies to test and compare different formulations (including formulation development, preparation, and analysis)
  • Multiple dosing to investigate the compound in steady state

We uphold the utmost standards of animal welfare, adhering to the 4R principles and holding AAALAC accreditation.

Certifications

To deliver high-quality solutions to our clients, we adhere to high standards for the development and manufacturing of your medicines:

AAALAC