In the field of pharmaceutical research, preclinical toxicology studies play a crucial role in evaluating the safety and potential toxicity of drug candidates before they enter human clinical trials. These studies help assess the risks, benefits, and optimal dosage of new compounds, ensuring the safety and efficacy of pharmaceutical products.

At AniLocus, we specialize in providing state-of-the-art preclinical toxicology services, employing cutting-edge techniques and methodologies to uncover valuable insights into the toxicodynamics and toxicity profiles of new drugs and biomaterials. Our comprehensive range of toxicology assessments helps guide decision-making in drug development processes.

Toxicity Testing Services

Acute Toxicity Testing

  • Single-Dose Toxicity Study: Administering a high dose of the test substance to mice and observing signs of acute toxicity over a short duration.
  • Subacute Toxicity Testing:
  • 14-Day Repeated Dose Study: Administering the test substance daily for 14 days and assessing subacute toxic effects.
  • 28-Day Repeated Dose Study: Similar to the 14-day study, but conducted over 28 days for longer exposure.

Subchronic Toxicity Testing

Chronic Toxicity Testing

Reproductive Toxicity Testing

  • Two-Generation Reproductive Toxicity Study: Assessing the impact of the test substance on reproductive performance, fertility, and offspring development over two generations of mice.

Developmental Toxicity Testing

  • Teratogenicity Study: Administering the substance during pregnancy to assess its potential to cause birth defects.
  • Developmental Neurotoxicity Study: Evaluating the impact of the substance on the neurodevelopment of offspring.

Genotoxicity Testing

  • Ames Test: Using bacterial strains to assess the substance’s mutagenic potential.
  • Micronucleus Test: Assessing the substance’s ability to induce micronuclei in the mouse’s bone marrow cells.
  • Comet Assay: Examining DNA damage in mouse tissues following exposure to the substance.

Dermal Toxicity Testing

  • Dermal Irritation Study: Applying the substance to the skin to assess its irritant potential.
  • Dermal Sensitization Study: Evaluating the potential for the substance to induce skin sensitization.

Inhalation Toxicity Testing

  • Inhalation Exposure Study: Administering the substance through inhalation to assess respiratory toxicity.

Neurotoxicity Testing

Organ-Specific Toxicity Testing

  • Hepatotoxicity Study: Focusing on assessing liver toxicity and damage.
  • Nephrotoxicity Study: Evaluating kidney toxicity and damage.
  • Cardiotoxicity Study: Investigating potential adverse effects on the cardiovascular system.

Immunotoxicity Testing

Toxicokinetics ADME Studies

Pharmacokinetics (PK) Studies

  • Bioavailability Assessment: Determining the extent and rate at which a substance is absorbed into the bloodstream following different routes of administration.
  • Plasma Concentration Profiling: Measuring the concentration of the test substance in blood plasma over time to understand its pharmacokinetic profile.

Absorption Studies

  • Permeability Assessments: Measuring the substance’s permeability across biological membranes (e.g., intestinal, blood-brain barrier) using in vivo models.
  • GI Tract Absorption: Studying the absorption of oral medications in the gastrointestinal (GI) tract to understand factors affecting bioavailability.

Distribution Studies

  • Tissue Sampling: Collecting and analyzing samples from various tissues to assess the distribution of the substance throughout the body.
  • Metabolite Identification: Identifying and characterizing metabolites in different tissues to understand where the substance is metabolized.

Metabolism Studies

  • In Vivo Metabolism: Evaluating in vivo metabolism by administering the substance to animal models and analyzing metabolites in biological samples.

Excretion Studies

  • Renal Excretion: Evaluating the excretion of the substance and its metabolites through the urine to assess renal clearance.
  • Biliary Excretion: Assessing the excretion of the substance into bile and its subsequent elimination through the feces.

Stability Studies

  • Stability Assessment: Determining the stability of the substance in various biological matrices (e.g., plasma, tissue homogenates) under different storage conditions.
  • Formulation Stability: Evaluating the stability of drug formulations to ensure shelf-life and administration reliability.

Mass Balance Studies

  • Total Recovery Studies: Conducting mass balance studies to account for the total recovery of the administered substance and its metabolites in various excreta (urine, feces).

Pharmacokinetic Modeling and Simulation

  • PK/PD Modeling: Performing pharmacokinetic/pharmacodynamic modeling to understand the relationship between drug exposure and effects, aiding in dose optimization.

Comprehensive preclinical toxicology studies are vital in evaluating the safety and potential toxicity of drug candidates before entering human clinical trials. At AniLocus, we offer a wide range of toxicology services, including acute and chronic toxicity testing, reproductive and developmental toxicity testing, genotoxicity testing, and organ-specific toxicity testing.

Additionally, our toxicokinetics ADME studies provide valuable insights into the absorption, distribution, metabolism, and excretion of substances in the body. With our state-of-the-art methods and expert team, we ensure the safety and efficacy of pharmaceutical products, contributing to the success of drug development processes.

Contact us today for a free quote and to learn more about our comprehensive preclinical toxicology CRO services.