Toxicology

With the knowledge and working skill competent employees, Liveon Biolabs is committed to march to the forefront of pharmaceutical product development. Liveon Biolabs safety services include toxicology (acute, subacute, subchronic, chronic toxicity, reproductive toxicity, genetic toxicology, carcinogenicity), pharmacokinetics and toxicokinetics services. Liveon Biolabs is a well established and approved testing facility which follows the OECD, GLP principles and USFDA guidelines in generating the quality toxicology data to meet international standards.

Liveon Biolabs offers a complete range of toxicology laboratory services to support pre-clinical studies. Our dedicated team of scientists including toxicologists, pathologists, veterinary surgeons and support personnel have designed and performed various trials ranging from acute to chronic toxicity. Customized and individual study designs helps our clients to reach their product development goals as planned. We can customize our in-vivo laboratory services to meet your unique objectives in a variety of different animal models to provide efficacy, pharmacokinetic and toxicology data.

Our support to acute toxicity studies includes the relationship between the exposure of animals to the test item and the incidence and severity of all abnormalities. Observations include behavioural and clinical abnormalities, reversibility of observed abnormalities, gross lesions, body weight changes, effects on mortality, clinical pathology and any other toxic effects as required by the client. We also provide histopathology services accordingly.

Our tests from acute studies in rodent and non-rodent species help determination of doses, routes, formulations and Criterias to be used in potential clinical trials in the advanced stages of pharmaceutical product development chain.

  • Acute Oral Toxicity
    • Fixed Dose Method
    • Classic Method
    • Up and Down Method
  • Acute Dermal Toxicity
  • Acute Dermal Irritation / Corrosion
  • Acute Eye Irritation / Corrosion
  • Acute Inhalation Toxicity
  • Skin Sensitization
  • Skin Absorption

Experimental data from sub-acute / subchronic / chronic toxicity studies in rodent and non-rodents helps for determination of doses, routes, formulations and criterias to be used for a potential clinical studies. Sub-chronic studies use a minimum number of animals and end-points and are aimed to evolve data that is used to make high-level project decisions with respect to more definitive studies with conclusions.

Sub Acute / Sub Chronic

  • Repeated Dose - 7, 14, 28 & 90 Days
    (Oral, Dermal, IV, IM, IP, ID & SC)
  • Maximum Tolerated Dose

Chronic / Carcinogenecity

  • Repeated Dose - 180, 270 & 360 Days
    (Oral, Dermal, IV, IM, IP, ID & SC)
  • Carcinogenecity Studies
  • Combined Chronic / Carcinogenecity

Genotoxicity studies are an essential requirement in preclinical testing program for drug approval. A variety of Genotoxicity screening assays play an important role in deciding quality of a test item in the early phase of drug development. Our facilities, support services and experienced laboratory management personnel offer the highest quality of work in compliance with OECD, GLP, ICH, ISO and other globally recognized guidelines.

  • AMES Test/Bacterial Reverse Mutation Test
  • Mammalian Chromosome Aberration Test
  • Mammalian Cell Micronucleus Test
  • Mammalian Cell Gene Mutation Test

Liveon Biolabs support studies in developmental toxicity (embryo-fetal development) models, pre- and postnatal development and multigenerational studies to assess the potential effects of pharmaceuticals, biopharmaceuticals and/or chemicals on the entire reproduction spectrum. A full range of rodent and non-rodent species are tested upon with various routes of Administration.

We have Robust study designs to assess fertility, embryonic development to implantation, fetal development, pre- and post-natal development, and maternal function, following international guidelines, including international conference of harmonization (ICH).

  • Fertility & Reproductive Toxicology
  • Developmental Toxicology & Teratology
  • Prenatal & Postnatal Studies
  • Two Generation Studies

Infusion Toxicity Studies

The variation in infusion procedure, the dose (Continuous /intermittent) and the target reach has complete impact on activity and efficacy of any pharma products. Determining these attributes will always be the second best needs of any pharma industry. We at Liveon Biolabs have complete capability to provide with complete support for Infusion Toxicity Studies.

Bone and Muscle Toxicology

Musculoskeletal research is in its peak to find the cure to Arthritis. To assess the safety and efficacy of drugs that have an intentional or unintentional effect on the musculoskeletal system is of immense requirement for present and future of human life.

Models and trials on comprehensive evaluation of bone and cartilage drug efficacy, musculoskeletal tissue healing and biocompatibility are in the list of Liveon Biolabs capabilities.

Whole Blood Perfusion Studies

For the study of nervous system/ neuro science and for any tissues involving rapid histopathology and immuno histochemistry studies.

Neurotoxicity/ Neurobehavioral Sciences

Neural connectivity is the base of human understandings and behavior. We have evolved efficient study designs and models to evaluate the neurotoxic effects of broad range of products including Pharmaceuticals, Biopharmaceuticals, Biomaterials and complex chemicals in rodent and non-rodent species.

  • Acute Neurotoxicity
  • Subchronic neurotoxicity
  • Developmental neurotoxicity
  • Behavioral developmental neurotoxicity
  • Safety pharmacology
  • Delayed Neurotoxicity of Organophosphorus Substances Following Acute Exposure
  • Delayed Neurotoxicity of Organophosphorus Substances: 29-Day Repeated Dose Study
  • Neurotoxicity Study in Rodents

Assessments

  • Auditory Starttle
  • Detailed Clinical Observation
  • Learning and Memory testing
    • Passive avoidance
    • Water maze studies (Hexagonal and Y maze studies)
    • Delayed spatial alteration
    • Step down active avoidance
    • Eyeblink conditioning
    • Sensory evaluation
    • Developmental reflexes
    • Facial symmetry
    • Muscle mass and tone studies
  • Pain/analgesia assessment
    • Tail flick, hot plate, Hargreaves, and writhing assays (rodent)
    • Tail withdrawal (rodent and nonhuman primates)

Cytotoxicity Studies

Agro-Chemical Studies

  • Skin Absorption: In Vitro Method
  • In Vitro Skin Corrosion: Transcutaneous Electrical Resistance Test (TER)
  • In Vitro Skin Corrosion: Human Skin Model Test
  • In Vitro 3T3 NRU Phototoxicity Test
  • In Vitro Mammalian Chromosome Aberration Test
  • In Vitro Mammalian Cell Gene Mutation Test
  • Genetic Toxicology: Sex-Linked Recessive Lethal Test in Drosophilia melanogaster
  • Genetic Toxicology: In Vitro Sister Chromatid Exchange assay in Mammalian Cells
  • Genetic Toxicology: DNA Damage and Repair, Unscheduled DNA Synthesis in Mammalian Cells
  • In Vitro Membrane Barrier Test for Skin Corrosion
  • Oral gavage
  • Subcutaneous (including implants)
  • Intravenous
  • Intradermal
  • Intramuscular
  • Intraperitoneal
  • Intravaginal
  • Intranasal
  • Dietary
  • Infusion