Preclinical Pharmacokinetics Testing Services

Understanding the pharmacokinetics of your compound is essential at all stages of the development process. Speed and flexibility is often of critical importance to enable you to make informed, data-driven decisions about your pipeline. Absorption Systems’ bioanalytical experts provide you with complete study support, from formulation to preclinical pharmacokinetic parameters, with rapid turnaround times.

Preclinical pharmacokinetics are a part of every drug’s development pipeline, and a core part of the USFDA general criteria for INDs. The primary aim of preclinical PKs is to define the level of pharmacologically active drug in the target compartment. This information is vital to inform dosing regimens, toxicology studies and formulation developments. Depending on the question, different model systems may be required.

Absorption Systems has expertise in using preclinical pharmacokinetics studies for:

Bioanalytical assessments of small and large molecule compounds
Analysis of a range of matrices (e.g. Plasma, Tissue, Urine, Feces, Bile, Lymph, CSF)
Biofluid samples from range of sites (e.g. jugular vein, portal vein, bile cannula, ureteral catheters, lymph cannula etc)
Atypical dose routes (e.g. IA, IN, Buccal, SL)
Toxicity & tolerability studies
Rapid turnaround requirements for plasma sample bioanalysis (72-hours)

The Absorption Systems Difference

We take a truly end-to-end approach to preclinical PK studies. From formulation to PK parameters, our experienced team have been supporting DMPK for over 30 years. Our combined expertise in both in vitro and in vivo preclinical PK studies mean we know the right questions to ask and how to answer them, across model systems. We also recognise the time-sensitive nature of these studies and offer rapid turnaround times that support drug discovery timelines.

FREQUENTLY ASKED QUESTIONS

What species do you work with?

We work with a range of preclinical models that enables us to select the most suitable model for a particular dose route, treatment regimen or endpoint. Our models include:

Dog
Guinea Pig
Mouse
Porcine
Rabbit
Rat

Do you work with specialized animal models?

What dose routes do you use?

Our scientists are experienced in a range of dosage routes, including more specialised routes. We have a selection of different preclinical models to match suitable routes of administration to:

Routine: IV, PO, SC, IM, IP
Standard: Ophthalmic, Dermal, Intranasal, Intraoral, Buccal
Specialty: GI (ID, IJ, IC), IT, Intra-articular

What toxicity/tolerability do you measure?

A summary of our toxicology and tolerability study details is given below:

Standard species

DRF/MTD

Toxicity & tolerability

Standard endpoints

Rodent
Rabbit
Dog
Minipig

7, 14, 28 and 90 day
Chronic (6-9+ months)

Clinical observations
Body weights
Food consumption
TK analysis
Histopathology
Clinical pathology

CAPABILITIES

Adaptable assays that get you the information you need:

Test Articles: Small and Large Molecules, Cell & Gene Therapy
Matrices: Plasma, Tissue, Urine, Feces, Bile, Lymph, CSF
Sample Analysis and Reporting: Measured concentrations and PK parameters
72-hour turnaround time for plasma sample BA
Biofluid Sampling: Jugular vein, Portal vein, bile, cannula, urine, feces, lymph cannula (other suitable veins), CSF, Synovial Fluid, and more

TECHNOLOGIES AND METHODOLOGIES

State-of-the-art assays analysed with cutting edge technology:

Bertin Precellys® 24 Tissue Homogenizer
LC-HRAMS
LTQ Orbitrap
VersaMaxTM Microplate Readers
Waters ACQUITY UPLC Systems
Waters Xevo TQ Systems

Visit our online store to view protocols or purchase Express PK studies. Request a custom study design.

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