Draconis Pharma

ADME in vitro,
DMPK & Toxicology

ADME in vitro, DMPK & Toxicology

These studies aim to evaluate how a drug is absorbed, distributed, metabolised, and eliminated by the body, as well as its pharmacokinetic properties, such as its bioavailability, half-life, and clearance.

Draconis Pharma provides a wide range of in vitro (ADME) and in vivo (DMPK) studies with the aim to evaluate how a drug is absorbed, distributed, metabolised and eliminated by the body. These parameters have a direct impact on the drug’s efficacy and safety. Rational planning of these assays early in the drug development process could help researchers during the development of a new therapy.

The ADME-DMPK-Toxicological characterization provides valuable information to make decisions at each stage of development:

Basic ADME & Physicochemical properties:

The physicochemical properties and an initial ADME panel generate results that inform decision-making in compound screening within the framework of pharmaceutical development. These results can aid in interpreting the outcomes of potency/efficacy assays conducted during these phases.
The most relevant assays included in this panel are as follows:

Kinetic/Thermodynamic Solubility
Lod D (pH7.4)
Chemical stability
Plasma Stability
Permeability (Caco-2)
Metabolic Stability (Microsomes)
Plasma Protein Binding

Advanced ADME & Pharmacokinetics (PK):

The selected products must be tested in a more advanced ADME panel to study in vitro metabolism. In this phase, it is necessary to include the in vivo evaluation of pharmacokinetic parameters of the compounds within the species of the efficacy and/or toxicological studies. This way, we can correlate efficacy in these models with the drug’s exposure.
The selected compounds need to undergo testing in a more advanced ADME panel to study in vitro metabolism. Additionally, in this phase, it’s crucial to include the in vivo evaluation of the compounds’ pharmacokinetic parameters within the species used for efficacy and/or toxicological studies. This correlation will help us link efficacy in these models with the drug’s exposure.»
The most relevant assays included in this panel are as follows:

Metabolic Stability (Primary Hepatocytes)
Drug-Drug Interactions (CYP450 isoforms)
In vitro Metabolite Identification (microsomes or hepatocytes)
Pharmacokinetic studies (mice/rat)

Preliminary Toxicological Studies:

It is important to gain insights into toxicological events and collect data for designing regulatory preclinical studies. The data generated in these preliminary non-GLP studies can have a significant economic impact by minimizing the risk of undesired toxicological effects appearing in costly GLP studies.

Draconis Pharma provides preliminary toxicological studies in rodents (mice/rats) as  a source of valuable information. Our team will tailor the study design to meet your specific needs and the stage of development of your project.

The most relevant assays included in this panel are as follows:

Dose Range Finding Studies (DRF)
Maximal Tolerated Dose (MTD)
Repeated Dose Toxicity Study (4-14 days)

By considering these and other factors, researchers can optimize the ADME DMPK properties of a drug and improve its chances of success in clinical trials and ultimately, its approval by regulatory agencies.