DMPK studies are conducted to determine the disposition of the drug and its metabolites using suitable animal models. The regulatory requirement for such studies both in rodent, rabbits and dog species used for the safety assessment of drugs reflects the importance of these data in understanding and interpreting findings from pharmacological and toxicity studies and in extrapolating to humans. Further, DMPK studies provide the bridge between safety studies in animals to humans and support the relevance of safety data generated in animal studies to humans. At present Vimta has capability to conduct the following studies:

Fast Track non-GLP & GLP PK/TK Profiling

• Single or multiple dose (s) – in Mice, Rat and/or Dog
• Oral &/or IV (or intended) route
• 2-6 animals/dose; 5-12 time points / client specific designs
• PK study in canulated animals as per client's requirement
• Tissue distribution studies
• In -vivo blood – brain barrier penetration studies.
• Submission of encrypted results through secured electronic media
• Data generation & compilation

End-points

• Oral BA (provided data on PO & IV is available)
• Elimination half life/cleavage, Clearance, Distribution vol.
• Metabolite identification and Follow up with GLP support with tissue kinetics