Pharmacokinetics & Toxicity
- Services
- 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) 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.
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 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.
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
Axiocell Biotech Sdn Bhd.
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