Sai offers Exploratory/Discovery Toxicology (non-GLP) services in Rodents (Rat and Mouse). Systems and Procedures are closely monitored and supervised by independent Quality Assurance Unit (QAU). Sai is capable of identifying potential toxicity of a NCE at an early stage of drug discovery, which facilitates candidate selection and rapid decision making for drug development.
Sai has proven experience to carry out a range of toxicology services for more than 200 NCE’s, which provided unified integration between discovery and development programs of our clients.
Study types include:
Acute Toxicity Studies
- Single-dose toxicity studies (Acute Toxicity/Maximum Tolerated Dose toxicity) with or without Toxicokinetics.
- Single Dose Administration and Observations for 7/14 Days
Sub-acute Toxicity Study
- 7-14 Day Repeated Dose Toxicity with or without Toxicokinetics study in Rats or Mice
- Dose Range Finding (DRF) studies (7/14 Days) with or without Toxicokinetics in Rats or Mice
- 14-28 Day Repeated Dose Toxicity with or without Toxicokinetics study in Rats or Mice
Study Duration/Dosing regimen/Study deigns/Parameters are followed as per sponsor’s objectives and need.
Routes of Administration
- Parenteral (Intravenous, Intra-peritoneal, Intra-muscular, Subcutaneous, Intradermal, Dermal, etc.)
- Rat (Wistar, Sprague Dawley)
- Mouse (Swiss albino, BALB/c, C57BL/6, etc.)
Parameters include study in-life phase observations (Body weights, Food consumptions, clinical signs, etc.), clinical pathology (Hematology, Clinical Chemistry and Urinalysis) gross and Histopathology.
Sai has a well-organized, Genetic Toxicology facility to conduct In-Vivo or In-Vitro Exploratory/Discovery Gentox assays required to predict potential mutagenesis of NCE’s in living organisms, including human which helps in selecting lead candidate as well as designing regulatory studies in development stage.
- Full Ames assay: In-Vitro Bacterial Reverse Mutation Test using Salmonella typhimurium (5 strains and 5 concentrations)
- Mini-Ames assay: In-Vitro Bacterial Reverse Mutation Test using Salmonella typhimurium (2 strains and 3 concentrations)
Chromosomal Aberration Assay (CA):
- In-Vitro Mammalian Chromosome Aberration Test using Human Peripheral Blood Lymphocytes
Micronucleus Test (MNT):
- In-Vitro Micronucleus test using Human Lymphocytes
Cell Gene Mutation Test (CGMT):
- In-Vitro Mammalian Cell Gene Mutation Test (HPRT assay) using CHO cell lines
Micronucleus Test (MNT):
- In-Vivo Mammalian Erythrocyte Micronucleus Test in Mice
Chromosomal Aberration Assay:
- In-Vivo Mammalian Bone Marrow Chromosome Aberration Test in Mice
Laboratory Animal Facility
The Laboratory Animal Facility at Sai is built in compliance with the Committee for the Purpose of Control and Supervision of Experiments on Animals (CPCSEA), under regulations set down by the Ministry of Environment, Forests and Climate Change, Government of India (Reg. No. 1240/PO/RcBi/S/08/CPCSEA) and has been accredited by AAALAC (Unit No. 001384) with excellent remarks in February 2011 and OLAW certification (Animal Welfare Assurance No. A5937-01) in May, 2012 for Animal Care and Use. The state-of-the-art animal facility is designed to conduct all animal experiments using rodents (rats and mice).
Animal experimentation protocols are approved and closely monitored by Institutional Animal Ethics Committee (IAEC)
[equivalent to IACUC]. The animal facility has been constructed with double corridor concept (clean and service) with a total area of 10,000 square feet with dedicated HVAC for 10 animal holding, 4 procedural rooms with isolated quarantine, surgery, necropsy and formulation preparation area.
Sai is committed to conducting animal experiments in an ethical and responsible manner.
Quality Assurance Unit
Sai operates as Quality Assurance Unit (QAU) that ensures quality and integrity of all our preclinical toxicology services as well as to maintain standard Animal care and use program.
The QAU affirms the stringent adherence to and compliance with our standard practices followed in all preclinical discovery services.
- Schedule and conduct study audits
- Schedule and conduct facility audits
- Generation of SOPs for all repetitive procedures,
- Generation of Recording formats for recording raw data
QAU performs frequent audits of all facilities involved in conduct of preclinical discovery services like animal house, pre-formulation, pathology area and supporting sections bioanalytical, maintenance and safety to assure quality services.
QAU also take care of Document Control activities (DOC), Test Item Control Office (TICO) and Archival Procedures.
Document Control Activities (Doc)
- Issuance of controlled recording formats
- Issuance of controlled copies of SOPS.
- Preparation and maintenance of master lists of SOPs, forms, instrument and equipment maintained in the facility
- Maintenance of Signature Log
- Maintain Master Schedule of all preclinical toxicity studies
Test Item Control Office (TICO)
Ensures safe receipt of the test items, maintains its inventory and issue logs. TICO maintains the test item in environmentally controlled storage till experimental usage or archiving.
Sai has an advanced and secured archival facility, spread across 1000 sq. feet in an environmentally controlled area, which offers strong traceable archiving and retrieval systems with in-house tracking system.