SIPRA has lot of expertise in management of toxicology studies on rodent & non-rodent species and toxicokinetic studies on Beagle dogs. A qualified team of study directors work closely with the clients to ensure that the studies are conducted in compliance with GLP principles as per OECD, ICH, FDA and Schedule Y guidelines.
The facility is designed as per CPCSEA/AAALAC and GLP guidelines and its fully equipped pathology laboratory is accredited by NABL for ISO 15189:2007 certification.
| Toxicology | Test Systems |
|
• Single dose (Acute ) toxicity |
• Mouse (Balb-C, Swiss-Albino, C57, Diabetic) |
Sipra Labs offers comprehensive range of in vitro and in vivo Genetic toxicology studies in compliance with GLP principles as per OECD, US-EPA (OPPTS), REACH guideline
Bacterial Reverse Mutation Test (Ames test) -
OECD 471
In Vitro Micronucleus Test - OECD 487
In Vivo Mammalian Bone Marrow Chromosome
Aberration Test - OECD 475
Bioassays, Pyrogen test , Abnormal toxicity and
Undue toxicity
Sipra is experienced in conducting pharmacokinetic (PK) studies including drug half-life, bio-distribution, bio-availability and safety evaluation. Sipra offers bio-analytical method development and validation to identify & quantify test articles, metabolites and degradation products in blood, urine and other biological fluids or tissues.
Permeability (Caco2, MDCK)
CYP Mediated Metabolism
Protein Binding
Microsomal Metabolic Stability
PK & Routs of Excretion
14C Studies (Mass Balance)