DMPK
SAI offers a broad set of DMPK-related services that support the specific needs of early discovery (Tier 1) as well as late discovery / early preclinical (Tier 2) programs.  The suite of services ranges from determination of physicochemical properties through in vitro stability testing to full-fledged in vivo PK studies in rodents.  Sai will begin offering dog PK services in 4Q 2010.  

Representation Tier 1 and Tier 2 assays include:

• Physicochemical properties including solubility, chemical stability, pKa, LogP and LogD
• Permeability assays (PAMPA, Caco-2 or MDCK)
• Metabolic stability using liver microsomes (rodent, dog, human) or cryopreserved hepatocytes
• CYP inhibition versus induction studies
• Plasma stability and protein binding
• Full PK studies in rodent (bioavailability and dose proportionality)
• Radioactive studies including in vitro metabolism and in vivo mass balance & tissue distribution studies in rats and mice
  

Toxicology
Sai offers non-GLP toxicology testing services to enable timely assessment of our client’s late-stage lead molecules.  We have well-established procedures and protocols to conduct acute toxicology assessment in rodent species including two-week non-GLP dose-ranging safety studies.   Early toxicological assessment includes general physiological and behavioral observations, clinical chemistry and pathology, necropsy and histopathology, and toxicokinetics.    

Sai is committed to continue expansion of DMPK and toxicology services to further support our clients’ needs.  Our near-terms plans include GLP Certification and AAALAC certified dog PK capabilities and expansion to accommodate chronic toxicology studies in multiple species.