From Concept to Proof of Concept info@advinus.com   

Genotoxicity studies

  • Ames test
  • In Vitro Chromosomal aberration test in CHO cells
  • In Vitro mammalian cell gene mutation test in CHO cells using the Hprt Gene and in Mouse Lymphoma cells using the Tkgene
  • In Vitro mammalian micronucleus test in CHO cells
  • In Vivo micronucleus test in rats/mice

Toxicology studies (In Vivo)

  • Acute 6 pack studies: Oral, Dermal, Inhalation, Dermal irritation / corrosion, Eye irritation/corrosion and Skin sensitization tests
  • Dose range finding toxicology studies in rodents (rats/mice)
  • Dose range finding toxicology studies in non-rodents
  • 28-day repeat dose toxicology studies in rodents (rats/mice)
  • 90-day repeat dose toxicology studies in rodents and non-rodents
  • 6 to 12 month repeat dose toxicology studies in rodents (rats/mice)
  • 6 to 12 month repeat dose toxicology studies in non-rodents
  • Carcinogenicity studies in rats/mice
  • Combined chronic toxicity and carcinogenicity studies in rats/mice
  • Combined repeated dose with reproduction/developmental toxicity screening studies in rats
  • Reproduction/developmental toxicity screening studies in rats
  • Segment II Developmental Toxicity studies in rodents and rabbits
  • 1, 2 and 3 generation reproduction toxicology studies in rats
  • Extended one-generation reproductive toxicity studies in rats
  • Developmental neurotoxicity studies in rats

Ecotoxicology studies:

  • Acute toxicity test in fish
  • Acute toxicity test in daphnia
  • Acute toxicity test in alga
  • Acute toxicity test in earthworm
  • Acute toxicity test in honey bee (oral & contact)
  • Ready biodegradability study (carbon dioxide evolution test)
  • Acute Toxicity in birds
  • Avian Dietary Toxicity in birds
  • Avian Reproduction Test
  • Oral through gavage, dietary or drinking water
  • Inhalation
  • Ocular
  • Dermal

Advinus has a long history of performing Good Laboratory Practice (GLP) compliant toxicology studies for regulatory filing. Advinus’ facilities has been GLP accredited by BfR German Health Ministry since 1992, when it became the first laboratory in India to get GLP accreditation . In 1999, W&V Netherlands, and in 2005, Indian GLP authorities also accredited this facility. In addition, the facility is also AAALAC International certified since 2001. The facility was also the first GLP facility in India, inspected by USFDA in 2012.
We have conducted more than 10,000 GLP studies for submissions to regulatory authorities globally including USFDA, EMA, MHRA, TGA, Health Canada and DCGI. Advinus has capabilities for full range of toxicology studies required by agrochemicals, , chemicals (REACH), dyes, and other such industries.

The studies conducted are compliant with OECD GLP and the study guidelines prescribed by the international regulatory agencies including but not limited to USFDA, USEPA (OPPTS), OECD, EEC, JMAFF, WHO, DCGI, DBT and CIB of India.
Our broad spectrum of GLP and non-GLP service offerings, along with our experience of over 3 decades, ensures meeting the current global toxicology testing requirements. Advinus’ experienced team enables study completion in the shortest possible time period such that regulatory submissions can be expedited.

All animal study protocols are reviewed and approved by Institutional Animal Ethics Committee (IAEC) which is similar to IACUC of AAALAC International.

Advinus’ vivarium is one of the largest in South Asia with over 80 rooms, which meets global standards of maintenance, operation and is approved by the CPCSEA, Government of India, and accredited by AAALAC International.

Advinus has completed full pesticide registration packages for global regulatory submissions, including US EPA. Further the company routinely undertakes chronic toxicity, reproduction toxicity, juvenile toxicity and carcinogenicity studies. The company has the experience of 58 carcinogenicity studies have been executed till date for submissions primarily to the US and EU regulators. The company has an extensive historical control dataset in rats (Wistar and Sprague Dawley) and mice (Swiss Albino). In addition to regular carcinogenicity studies, the company has also successfully performed 6 month carcinogenicity study in Tg RasH2 transgenic mouse model, a service offering that is offered by only a few global nonclinical contract research organizations.

Advinus takes pride in the fact that the toxicology team has 35 highly qualified study directors with an average of 15 years of industry and regulatory exposure. Advinus also has 9 Diplomates of the American Board of Toxicology (DABT) certified toxicologists.

2 YEAR CARCINOGENICITY STUDIES

  • Over two decades of experience conducting carcinogenicity studies in accordance with OECD guidelines
  • Highly skilled study directors with 15-20 years of experience handling carcinogenicity studies in rodents
  • Completed 58 studies with extensive historical control data both for Agro and Pharma compounds
  • Clients distributed world-wide, including USA and Europe
  • Data successfully submitted to regulatory agencies around the world
  • Only center in the region to support carcinogenicity studies with wealth of experience and historical data
  • Capability to compile study data files in accordance to FDA approved “Standard for Exchange of Non-Clinical Data (SEND)” format for regulatory submission
  • Peer review pathology services by independent overseas ‘Board Certified Pathologists’ is offered

LOCAL LYMPH NODE ASSAY (LLNA)

  • Advinus has more than a decade of experience in conducting LLNA studies in mice.
  • LLNA test has largely superseded the guinea pig maximization test and the Buehler test.
  • Extensive experience in LLNA studies in mice conducted as per OECD guideline No. 429 to provide quantitative data suitable for dose response assessment.
  • Advinus has the necessary analytical support and equipment to support Toxicology services for Agrochemical and Industrial Chemicals.
  • Digital Pathology Services
    • Efficient and validated in-house software packages for statistical analysis and interpretation of data
    • Historical data accumulated over the years available on Clinical signs, Body weight, Feed intake, Hematology and Clinical Chemistry, Histopathology and Tumor incidence. In addition, historical data available for all types of reproduction studies, including fertility, pre and/ or postnatal studies and genetic toxicology studies.
  • IT support to meet client needs
  • An independent Quality Assurance Unit (QAU).