In Vivo Pharmacology Services

Altogen Labs provides in vivo pharmacology services for preclinical oncology and therapeutic development programs, conducted in mouse and rat models within an IACUC-regulated facility. The service family covers dose range finding and maximum tolerated dose determination, single and repeat-dose administration studies, pharmacokinetic and pharmacodynamic characterization, ADME and DMPK profiling, tissue distribution and biodistribution studies, blood-brain barrier and central nervous system exposure work, necropsy with tissue collection, and the molecular and pathology endpoints that convert an observed effect into a mechanistic result.

These studies establish how a test article behaves in a living system: the exposure it achieves, the biological response that exposure produces, the dose at which the response becomes measurable, and the dose at which it becomes intolerable. In oncology programs they are frequently run within a single protocol alongside tumor efficacy studies, so exposure, pharmacodynamic response, and antitumor effect are measured in the same animals rather than inferred across separate cohorts.

Altogen Labs has conducted in vivo pharmacology and efficacy studies for pharmaceutical, biotechnology, and academic clients worldwide, including work supporting IND-enabling packages, patent applications, and peer-reviewed publication. Company scientists have published preclinical antitumor and mechanism data and understand the study design and documentation standards that determine whether a dataset is usable beyond internal decision-making.

How Altogen Labs supports a program

Most delay in preclinical pharmacology comes from work distributed across several providers. Formulation is assessed in one place, dosing conducted in another, bioanalysis outsourced to a third, and tissue endpoints commissioned later from whatever material survived. Each handoff adds scheduling time, and each introduces a point where sample handling sits outside the control of the group interpreting the data.

Altogen Labs runs formulation assessment, animal work, sample collection, and analytical endpoints in one facility under one protocol. The consequences are specific. Tissue is stabilized at necropsy according to the requirements of the endpoint it will feed, rather than by a default method chosen before the endpoint was known. A single animal supports pharmacokinetic sampling, pharmacodynamic readouts, histology, and archival storage, reducing cohort size and removing the inter-animal variance that arises when different endpoints are measured in different subjects. When a result is ambiguous, the material needed to resolve it is already in the building.

Study design support is provided before a protocol is fixed. Route, formulation, dose range, sampling schedule, and endpoint panel are frequently the difference between a study that answers its question and one that does not, and these are settled in discussion rather than assumed from a standard template. To begin that discussion, request a quote.

Dosing and tolerability

Intravenous, intraperitoneal, subcutaneous, oral, intratumoral, and intranasal administration are supported, with formulation assessed for the chosen route before a study opens. Dosing schedules range from single-dose characterization to repeat-dose regimens sustained across the duration of an efficacy study.

Dose selection proceeds from a dose range finding phase in which escalating doses are administered to small cohorts and assessed against body weight, clinical observations, and defined humane endpoints, establishing the maximum tolerated dose and the working range. Running this as a discrete preliminary step is more efficient than absorbing tolerability failures inside a fully powered efficacy study, where a poorly chosen high dose can compromise an entire treatment arm and cost several weeks.

Cohort size is set by power calculation against the expected effect size and the variance characteristic of the specific model. Randomization is stratified by baseline body weight, or by baseline tumor volume where a tumor model is used.

Sampling, exposure, and tissue distribution

Serial blood sampling across a defined time course generates the concentration-time profile from which exposure parameters are derived. Sampling volume in the mouse constrains the number of timepoints obtainable from one animal and often requires composite sampling; in the rat a full time course can usually be taken from a single animal, removing inter-animal variance from the profile. This difference frequently determines species selection when exposure is central to the question, and both are supported, including rat tumor models where efficacy and serial pharmacokinetics are required in the same animal.

Tissue collection at protocol-defined timepoints extends the analysis from systemic exposure to tissue distribution, which matters whenever the target compartment is not plasma. Tumor, liver, kidney, spleen, lung, and brain are collected routinely and the panel is set by the intended site of action. Samples are processed and stabilized according to the downstream analytical method.

Pharmacodynamic endpoints

Pharmacodynamic readouts are selected to match the mechanism under investigation and sampled alongside the exposure timecourse, so response is read against concentration rather than against time alone. Available endpoints include target gene expression by quantitative PCR, protein expression and phosphorylation state, circulating and intratumoral cytokines, immune cell populations by flow cytometry, and immunohistochemical assessment of proliferation, apoptosis, and target engagement in tissue.

Examples in drug testing

Tau antibody testing in mice. Anti-tau antibodies are administered to transgenic mice carrying brain pathology, and tau levels in brain tissue are measured by ELISA against vehicle controls to establish whether the antibody produces target reduction in the relevant compartment.

Metabolic studies. A candidate compound is administered to obese mice across a repeat-dose schedule, with body weight, food intake, and blood glucose tracked over the treatment period to establish whether the compound produces metabolic effects and at what dose.

Tumor growth inhibition. An anticancer agent is administered to immunocompromised mice bearing engrafted human tumor cells, with tumor volume measured across the treatment period and tumor growth inhibition calculated against vehicle controls to demonstrate the effect of the test article on tumor growth.

Integration with disease models

Pharmacology studies may be conducted in healthy animals where the objective is exposure and tolerability characterization, or within a disease model where the objective requires a biological substrate. Oncology programs integrate pharmacology with validated xenograft models, including syngeneic and humanized systems where the mechanism depends on an intact or reconstituted immune compartment, and immuno-oncology platforms where immune monitoring forms part of the pharmacodynamic readout. Nucleic acid therapeutics are assessed alongside in vivo delivery and tissue targeting, with biodistribution of the delivery vehicle and knockdown of the target transcript measured in the same study.

Protocol standards and animal welfare

All procedures are conducted under active IACUC protocols in an IACUC-regulated facility. Study protocols specify dose levels, administration route and schedule, sampling times, analytical endpoints, acceptance criteria, humane endpoints, and the statistical analysis plan before initiation, so that analysis is pre-specified rather than selected after the data are seen. Animal numbers are justified by power calculation, and refinement measures appropriate to the model are applied. GLP standards are applied where a study is formally designated as GLP. Regulatory safety studies conducted to OECD test guidelines are described separately under Safety Toxicology Services.

Send compound, indication, and study objectives to discuss protocol design, or request a quote.