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 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 |
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