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Toxicology

TOXICOLOGY

Toxicology and safety studies identify potential target organs for adverse effects and define the Therapeutic Index to set the initial starting doses in clinical trials.
We provide complete solutions complying with current regulatory toxicology requirements. All studies are carried out in full compliance with Good Laboratory Practice (GLP).

 

  • Acute toxicity studies
  • Dose range Finding (DRF)
  • Initial Early studies Non GLP
  • Initial Early studies Non GLP
  • Inhalation toxicology studies
  • Chronic & reproduction studies
  • Maximum Tolarated Dose (MTD
  • Subacute and subchronic toxicity
  • Irritation and sensitization studies
  • Bacterial assays
  • Genetic toxicity
  • Teratological studies
  • Chronic toxicity studies
  • Pre and Postnatal Toxicity
  • Chronic carcinogenicity studies
  • Multigeneration reproduction toxicity
  • In vitro mammalian cytogenetic assays
  • In vitro mammalian cell gene mutation assays
  • Combined chronic feeding carcinogenicity studies

GENERAL TOXICITY

  1. Acute Toxicity Studies
  • Acute Oral (OECD 420, OECD 423)
  • Acute Dermal (OECD 402)
  • Acute Inhalation (OECD 403)
  • Acute Dermal irritation/Corrosion (OECD 404)
  • Acute Eye Irritation/Corrosion (OECD 405)
  • Skin Sensitization (OECD 406/ OECD 442B)

2.Repeated dose Toxicity Studies in  Rodents and Non-rodents

  • Sub-acute Toxicity -14 days DRF
  • Sub-acute 28 days Toxicity (OECD 407)
  • Sub-chronic 90 days Toxicity (OECD 408)
  • Sub-acute inhalation (OECD-412)- Will be conducted at partner site
  • Chronic Toxicity (180 and 360 days) (OECD 452)
  • Toxicokinetics

 

3. In Vitro Alternative Assays

  • In vitro skin corrosion (OECD TG 431)
  • In Vitro Skin Irritation (OECD TG 439)
  • Skin Sensitization (DPRA Assay, OECD TG 442C)
  • In Vitro Eye Irritation Test (OECD TG 492)