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Pharmacokinetics
(PK)

Rodent pharmacokinetics (in life) vivarium studies are conducted in-house 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
Quality
Systems
  • Procurement of animals from certified vendors (local subsidiaries of Taconic Biosciences, Charles River Laboratories and The Jackson Laboratory)
  • Documentation of animal health status at receipt
  • Subjecting all newly arrived animals to quarantine
  • Physical examination of animals by a veterinarian
  • Clinical tests:
    – Parasitological examination
    – Haematological
    – Biochemical
    – Microbiological examination of feces for pathogenic organisms on blood agar
    – Feed, water and bedding material analysis
  • Ethical efforts to avoid pain and distress to experimental animals
  • Anaesthesia and euthanasia as per CPCSEA guidelines

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 TypeTAT (Days)Compound Requirement (mg)
Rat PK525
Mouse PK: serial sampling510
Mouse PK: parallel sampling520
Rat Blood Brain Barrier515
Mouse Blood Brain Barrier515
Cassette dosing525 in rats