GET IN TOUCH

Pharmacokinetics
(PK)

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.

Typical Compound Requirements for PK Studies
Study Type TAT (Days) Compound Requirement (mg)
Rat PK 5 25
Mouse PK: serial sampling 5 10
Mouse PK: parallel sampling 5 20
Rat Blood Brain Barrier 5 15
Mouse Blood Brain Barrier 5 15
Cassette dosing 5 25 in rats
× img

Contact An Expert Today!