Rodent pharmacokinetic (in life) studies are conducted in the Aragen vivarium on different strains of mice and rats, in accordance with the following certifications, compliances and quality systems:
Certification & Compliance
AAALAC accredited rodent vivarium facility
In-house facility for rodent equipped IVC/ conventional cages
OHSAS (Occupational Health and Safety Assessment Series) compliant
Procedures compliant to Institutional Animal Ethics Committee (IAEC) comprised of external members and a Committee for the Purpose of Control and Supervision of Experiments on Animals (CPCSEA) nominee
IAEC approved and committee reviewed protocols of study experimentation
Institutional Bio Safety Committee (IBSC) registered under the Department of Biotechnology, India
Bio-waste disposal management registered under the State Pollution Board
EMS (Environment Management System) as per ISO 14001
Certification & Compliance
AAALAC accredited rodent vivarium facility
In house facility for rodent equipped IVC/ Conventional cages
OHSAS (Occupational Health and Safety Assessment Series) compliant
Procedures compliant to Institutional Animal Ethics Committee (IAEC) comprised of external members and a Committee for the
Purpose of Control and Supervision of Experiments on Animals (CPCSEA) nominee
IAEC approved and committee reviewed protocols of study experimentation
Institutional Bio Safety Committee (IBSC) registered under the Department of Biotechnology, India
Bio-waste disposal management registered under the State Pollution Board
Environment management system (EMS) as per ISO 14001
Ninety SOPs have been established for the regular functioning of the vivarium and for the various studies being conducted.
Cannulations
Jugular vein
Portal vein
Bile duct
Femoral vein
Double cannulation
In-house, experienced scientists conduct cannulations, ensuring minimal stress to the animals, with cost-effectiveness. Sampling can be done through portal/ tail/ saphenous/ submandibular veins. Wherever possible, we employ the principle of 3Rs. Serial sampling is preferred, to reduce the number of animals and generate quality, robust data.
Routes of
Administration
Oral
Intravenous
Intra-peritoneal
Subcutaneous
Intramuscular
Intra-tracheal
Sublingual
Buccal
Intra-duodenal
Intracolonic
Intranasal
Intra-articular
Types of Studies
Single/ multiple doses
Dose linearity
Tissue distribution (49 different tissues can be extracted after perfusion): cold compound
Alternate dosing
Cassette dosing (n=5, inclusive of one reference compound)
Broncho-alveolar lavage study
Drug-drug interactions
Fed/fasted state
Blood brain barrier and cerebrospinal fluid (even from mice)
Excretion studies (bile, urine and faeces: collected in temperature-maintained metabolic cages)
PK/PD
Cytochrome P450 inhibition by 3-amino-benzotriazole
Mechanistic studies
Strains
Rats: Wistar, Han Wistar and Sprague Dawley
Mice: Swiss Albino, CD1; Balb/c, C57BL6
Rabbits
Mini pigs
Guinea pigs
Large Animals: Canine PK studies are conducted with an external collaborator having a colony of more than 400 animals at a time.
We offer a combination of in vitro and in vivo toxicology assays coupled with GLP bioanalysis to help de-risk drug candidates and enable critical and timely go/no-go pipeline decisions.
FAQ
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