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General Toxicology(exploratory & regulatory)

Vimta has many years of experience and has qualified staff to design and conduct toxicology studies in accordance with the requirements of product under test according to the most recent international guidelines (ICH, FDA, and OECD). The studies are conducted in full compliance with Good Laboratory Practice (GLP) regulations. We have expertise in using varying routes of administration: oral (capsule, diet, gavage), parenteral (intravenous, subcutaneous, intradermal, intramuscular, and intra-peritoneal), dermal, intranasal, intra-vaginal/intra-penile, rectal and ocular.

Our expertise is in the following areas

Exploratory toxicity screens (early identification of ADEs, Non-GLP studies)

  • MTD studies in mice, rats, rabbits & beagle dogs with TK
  • 7-14 day DRF studies in mice, rats, rabbits & beagle dogs

Regulatory toxicity studies(IND-enabling & GLP Compliant)

The following toxicology services are conducted based on international guidelines (ICH, FDA and OECD). The studies are conducted in full compliance with Good Laboratory Practice (GLP) regulations.

General Toxicology (in mice, rat, Guinea pig, rabbit & beagle dogs)

Acute systemic toxicity studies to thoroughly describe the single dose toxicity

Short term repeat dose studies with toxicokinetics

Range finding studies in studies in rodents, rabbits and eagle dogs and through different dose routes primarily to identify dose range for initial sub chronic studies.

14 day to 28 day repeat dose studies in rodents rabbits and beagle dogs and through different dose routes with toxicokinetics

Other studies

  • Biocompatibility studies on medical devices as per ISO 10993
  • Skin/Eye irritancy in rats, rabbits
  • Sensitization studies in guinea pigs

   
 
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