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Exploratory and GLP Toxicology Studies

Aurigene Pharmaceutical Services offers a full range of exploratory and GLP toxicology studies supported by clinical and anatomic pathology services, formulation analysis, toxicokinetic analysis, and interpretation and reporting. General toxicology studies range from single-dose and repeat dose toxicology studies, genetic toxicology, and IND and NDA enabling safety toxicology package. We have a track record of successfully filing IND’s using the in-house data with the US FDA, MHRA, EMA and DCGI and ANDAs with US FDA.

The toxicology services team has experienced and qualified scientists with DABTs and DIBTP certified pathologists. Central to our ability to deliver world-class toxicology services to our global clients from our state-of-the-art vivarium for conducting toxicology studies in rodents. Our facility is GLP certified since 2003 and has sufficient capacity to undertake genetic and GLP toxicology studies.

Our labs are access controlled and spread over 18,040 square feet. The rodent animal facility is a double corridor facility with dedicated experimental rooms equipped with Individually Ventilated Cages (IVC). This animal facility is registered under the Committee for the Purpose of Control and Supervision of Experiments on Animals (CPCSEA), India. Our toxicology facility has been inspected by US FDA and National GLP Compliance Monitoring Authority (NGCMA). Our stringent data management is GLP compliant and periodically backed up and the systems and processes are rigorously monitored by an independent Quality Assurance unit (QAU).

Aurigene Pharmaceutical Services has proven experience to carry out a range of toxicology services to provide seamless integration between discovery and development programs.

Toxicology studies include:

  • General Toxicology (Includes Toxicokinetic)
    • Acute toxicity (GLP/Non-GLP): Rats/ mice
    • Exploratory/Dose range finding (MTD): Rats/ mice
    • Sub-acute (14/28 Day), sub-chronic (90 day) and chronic toxicity (6/12 months): Rats/ mice
    • Drug impurity qualification studies: Rats/mice
  • Reproduction Toxicity Studies (including toxicokinetic)
    • Fertility and reproductive toxicity (Segment 1 study): Rats
    • Male fertility study
  • Genetic Toxicology Studies
    • Aurigene routinely conducts IND enabling studies and the following in-vitro and in-vivo genotoxic studies to support candidate selection.
    • Bacterial reverse mutation test (Ames test), both mini Ames and standard Ames
    • In-vitro chromosome aberration test in CHO cell lines and human peripheral blood lymphocytes
    • In-vitro micronucleus test in CHO cell lines and human peripheral blood lymphocytes
    • Micronucleus test in rodents (rats and mice)
  • Pharmacokinetics
    • Single /multiple-dose PK: Rats/ mice and beagle dogs
    • Tissue distribution in rats/mice using in-situ perfusion techniques
    • Safety Pharmacology services include
  • Safety Pharmacology services include
    • Cardiovascular - In-vitro hERG – Automated patch clamp (Non-GLP)
    • CNS - Functional observational battery tests in Rats/mice

Routes of administration

  • Oral (gavage)
  • Intravenous bolus and infusion
  • Intramuscular
  • Intraperitoneal
  • Subcutaneous
  • Dermal

Bioanalytical

Our GLP facility is specialized in the development of bioanalytical methods to support bioavailability and pharmacokinetics studies. The services include:

  • HPLC-UV and LC-MS/MS based methods
  • Development of analytical methods in the presence of different matrices (plasma, brain, liver, bile, etc)
     

Toxicokinetic

  • Toxicokinetic studies are performed with a variety of animal models in a dedicated and quality-assured GLP environment.
  • Fully integrated bioanalytical analysis
     

Clinical chemistry and histopathology

Our state-of-the-art facility helps us provide a broad-based analysis of a variety of parameters in each of the following categories:

 

Clinical pathology

  • Clinical pathology lab to cater to haematology, clinical chemistry and urinalysis services
  • Biological samples analyzed – blood, plasma/serum and urine
  • Parameters measured: Complete Blood Count (CBC), routine clinical chemistry analytes, electrolytes, coagulation, hormones and urine parameters
  • Instruments: Siemens ADVIA 2120 automated hematology system, Medonic M Series hematology analyzer, Dade Behring Dimension Xpand Plus automated clinical chemistry analyzer, Siemens RAPIDChem electrolyte analyzer, Stago Start coagulation analyzer, Bio-Tek ELISA plate reader and Uriscan Pro II urine analyzer
     

Histopathology

  • Dedicated necropsy suite, specimen storage and histopathology lab to support all types of toxicology studies
  • Necropsy procedures, tissue trimming/ tissue processing and slide preparation as per RITA and goRENI guidelines
  • Systematic specimen collection, identification, preservation and archiving
  • Routine and special staining techniques including Immunohistochemistry (IHC)
  • Expert microscopic evaluation of slides by experienced board-certified pathologists and subsequent peer review
  • Instruments: Leica ASP 300S automated tissue processor, Thermo Citadel 2000 tissue processor, Thermo Histocentre 2 embedding station, Leica Histoscore/Arcadia tissue embedding station, Leica ST 5020 multistainer, Thermo Varistain Gemini ES multistainer, Themo Microm HM microtomes and Nikon E800 microscopes with UV lamp

FAQ

Toxicology studies help drug discovery scientists understand the adverse effects of New Chemical Entities (NCE) when administered to treat a disease. The studies are done on in-vitro assays and in in-vivo animal models to know the toxicity profile.

Good Laboratory Practise (GLP) toxicology studies are conducted under certified regulatory conditions. The studies are carried out based on procedures laid down by OEDC principles.

The purpose of toxicology studies/tests is to know the adverse/harmful effects of New Chemical Entities (NCEs) on the body of the organism on administration. These studies/tests help drug discovery scientists to design drugs.

Toxicology tests require a lot of time for chronic toxicity tests (6 to 12 months), other studies such as sub-acute (14 to 28 days), sub-chronic (90 days) require less time when compared to chronic toxicity tests.

Mice, rats, guinea pigs, hamsters, rabbits, dogs, monkeys, and minipigs are commonly used in in-vivo toxicity testing.

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