ADME/DMPK Services

Absorption, distribution, metabolism, excretion, and pharmacokinetics determine whether a compound with demonstrated activity in culture has any prospect of producing that activity in a patient. A molecule that is poorly absorbed, cleared before it reaches the target tissue, or metabolized to an inactive form will fail in vivo regardless of its potency against the isolated target, and the failure will look like a lack of efficacy rather than what it is.

Altogen Labs provides ADME and DMPK characterization tailored to the compound, route, formulation, intended indication, and the specific decision the data must support. Work is conducted alongside in vivo pharmacology and efficacy studies in the same facility, so that exposure and response can be measured in the same animals rather than assembled from separate programs conducted months apart.

To discuss which ADME endpoints a program actually needs, request a quote.

Capabilities

In vivo pharmacokinetic studies are conducted with protocol-defined blood and tissue sampling across a time course appropriate to the expected exposure profile. Bioavailability and exposure assessment are performed for applicable routes of administration, typically by comparing an extravascular route against intravenous administration in matched animals.

Permeability and physicochemical profiling are performed where relevant to the delivery question. Metabolism profiling and cytochrome P450 inhibition or induction assessment are supported as the program requires, together with drug-drug interaction risk assessment and biomarker measurement. Tissue distribution work, including blood-brain barrier related evaluation, establishes whether the compound reaches the compartment where the target resides.

Scoping the work to the decision

Not every program needs every endpoint, and running a full ADME package on a compound that will be deselected for other reasons is an expensive way to reach the same conclusion. The useful question at the outset is which decision the data is meant to inform.

Early discovery programs comparing several candidates typically need exposure and half-life sufficient to rank them, not a complete metabolic profile. Programs selecting a dose for an efficacy study need exposure at the proposed dose and route, and confirmation that the exposure is sustained across the dosing interval. Programs approaching IND-enabling work need the broader package, including metabolism, interaction risk, and tissue distribution, because those questions will be asked by reviewers whether or not they were asked internally.

Integration with pharmacodynamics and efficacy

Exposure data interpreted in isolation answers a narrow question. Linked to pharmacodynamic and efficacy endpoints, it answers the question programs actually have: what exposure is required to produce the biological effect, and whether the dose that achieves it is tolerated.

For oncology studies, pharmacokinetic and pharmacodynamic sampling can be incorporated into xenograft or other in vivo designs, so that plasma concentration, tumor concentration, target modulation, and tumor response are all measured in the same study. Where the compound is a nucleic acid or requires a delivery vehicle, distribution of the vehicle is assessed alongside activity of the payload through formulation and delivery services.

Applied examples

Route comparison. A candidate is administered intravenously and orally at matched dose in parallel cohorts, with plasma concentration followed across a full time course, establishing oral bioavailability before an oral efficacy study is designed around an assumption about it.

Tumor exposure. Plasma and tumor concentrations are measured at matched timepoints in tumor-bearing animals, establishing the tumor to plasma ratio and whether target tissue exposure is sufficient to explain, or fail to explain, the observed efficacy.

Dosing interval selection. Concentration is followed across twenty-four hours after a single dose, identifying the interval over which the compound remains above the concentration associated with target modulation, which then sets the dosing frequency for the efficacy study.

Program-specific scope and method definition

The analytical platform, sampling schedule, matrices, timepoints, and data outputs are defined for each project rather than drawn from a fixed panel, and the capabilities described here should not be read as a standard package applied to every study. Method suitability for the matrix and concentration range is established before samples are generated, since a study that produces samples no method can measure has failed regardless of how well the animal work was conducted. All in vivo procedures are conducted under active IACUC protocols, and GLP standards are applied where a study is formally designated as GLP.

Send compound properties, route, and the decision the data must support, or request a quote.