Pharmacokinetics & Toxicity

Predicts the pharmacokinetics safety and toxicity of drug candidates through integrated in vitro and in vivo studies to support drug selection and late-stage preclinical development.

Drug Metabolism and Pharmacokinetics (DMPK)

Drug metabolism and pharmacokinetics (DMPK) examine how therapeutic compounds are absorbed, distributed, metabolized, and eliminated by the body. Early-stage in vitro and in vivo assessments of ADME properties are vital for identifying and refining lead compounds and for enabling a smooth transition into advanced preclinical and clinical studies.

Axiocell delivers end-to-end DMPK solutions tailored to the needs of modern drug development. Our expertise spans the characterization of physicochemical properties, formulation strategies, dosing regimens, selection of relevant animal models, routes of administration, and customized bioanalytical methodologies to ensure comprehensive support at every stage of the discovery pipeline.

SERVICES

In Vitro ADME Assays

A . Physicochemical Analysis

  • Kinetic, Thermodynamic Solubility, pKa, Log P/Log D 
  • Chemical stability at different pH, SIF and SGF buffer

B . Permeability

  • PAMPA, Caco-2, MDCK, MDCK-MDR1 cells
  • Transporter Inhibitor or Substrate Identification

C. Distribution

  • Plasma Protein Binding
  • Blood to Plasma Ratio

D. Drug Metabolism

  • S9 / Hepatocyte / Liver Microsomes in Multiple Species

E. Drug-Drug Interaction

  • CYP Inhibition / Induction – Time-dependent

In Vivo Pharmacokinetics

Species: Mice / Rats / Beagle Dogs

Dose : Single / Multiple / Cassette dosing

Route of administration: Oral ,  IV,   I.P,  S.C,  Intramuscular

Bioanalytical Method: LCMS/MS or ELISA

Parameter: Half-life, Tmax , Cmax , AUC(0-t) , Tissue Distribution

Route of Administration

Intraperitoneal (i.p.)

Oral gavage (p.o.)

Intravenous (i.v.)

Subcutaneous (s.c.)

Intramuscular (i.m.)

Intratracheal

Intratumor

Bladder perfusion

Superficial temporal vein

Retro-orbital intravenous

Inguinal subcutaneous fat

Intracranial

Intradermal (i.d.)

Intraosseous (i.o.)

Intranasal

Intravitreal (IVT)

Intrathecal (i.t.)

Intraocular

Oropharyngeal aspiration

Sample Collection

All Major Organs

Urine

Blood

Adipose partition

Cerebral partition

cerebrospinal fluid

Spinal flush

Bone marrow

Bone marrow

Aorta

Liver biopsy

Cardiac retrograde perfusion

Fetal heart

Retinal

Hepatic perfusion

Dorsal root ganglion

Alveolar lavage

Peritoneal lavage

Safety Assessments (Toxicity)

Safety assessment investigates how drug candidates may impact biological systems. Using acute, sub-chronic and chronic toxicity tests along with targeted safety evaluations such as hematology, histopathology, immunogenicity). Researchers able to detect harmful effects determine safe dose limits and evaluate potential risks before advancing to clinical trials.

All studies are conducted in compliance with international guidelines (OECD, ICH, FDA/EMA) to ensure data integrity and regulatory acceptance.

SERVICES

In Vitro Toxicity

A. In vitro cytotoxicity / cell viability / apoptosis test

  • Cell Lines (Single / Full Panel)
  • Patient-derived Organoids (PDOs)

B. hERG screening

In Vivo Toxicity

A. General Toxicity – GLP or Non-GLP

  • 14-day Acute Tox
  • 28 / 60 / 90-day Sub-chronic Tox
  • Chronic Tox

B. Non-GLP Toxicity

  • Maximum Tolerated Dose (MTD)
  • Dose Range Finding

C. Toxicokinetic studies

Genotoxicity

A. In vitro

  • Bacterial Reverse Mutation Assay (Ames)
  • In Vitro Micronucleus Assay
  • In Vitro Chromosomal Aberration Assay
  • In Vitro Mouse Lymphoma Assay (MLA)

B. In vivo

  • In Vivo Micronucleus Assay

Immunogenicity

  • Anti-drug Antibody (ADA) Detection
  • Neutralizing Antibody
  • IgG & IgM Detection
  • Cytokine Release Syndrome (CRS)
  • Immune Profiling