PBPK and mechanistic model based solutions

A predictive future of smart decisions 

Our strong expertise in Physiological pharmacokinetic modelling (PBPK) provides you a wide range of possibilities to speed up your research by making informed decisions and or creating better clinical designs. These solutions provide significant cost advantages as well as allowing early regulatory acceptance of your research. Regulatory agencies acknowledge PBPK-based mechanistic model driven assessments as a valid methods for crucial decisions in areas like dose selection, evaluation of interaction potential with deciding on the optimum number of studies or study waivers, as well as studies in special populations etc.

Being mechanistic and modular in design, PBPK models are flexible and can be enhanced as more information becomes available.

This opens up a spectrum of possibilities for optimisation and minimising uncertainity.

Evaluate DDI  potential

Pharmacokinetic drug-drug interactions can cause clinically relevant changes in magnitude of blood and tissue concentrationof the investigational drug, its metabolites. or a co-administered drug . This may alter the safety and efficacy profile, regardless of whether they have a wide or narrow therapeutic index and may result in serious adverse events.

Drug-drug interaction can differ among individuals based on genetic variation (polymorphism) as well as in special populations (organ impairment, pediatric or geriatric).

Derive from a series of carefully planned  experimental  studies on in-vitro metabolism, enzyme inhibition and transporter assays, the early indications of the potential for drug interaction utilizing various static or mechanistic models , finally evaluating critical areas with PBPK based simulation.

"Utilize the vital information for optimal clinical trial designs or in support of study waiver"

Power of mechanistic model based simulations

Mechanistic simulations could be expanded to include various facets of clinical development exploring various "What if scenario's" enhancing the power of simulations

• Disease progression models

• Systems biology pathways

• BioPharmaceutical performance

Simulation of drug profiles in various Sub populations

• Pediatric

• Geriatric

• Renal and Hepatic impaired

Comparative evaluation with Standard of Care

A powerful tool to compartively evaluate clinical profiles and PKPD indices to known standard of care to identify potential merits, course correction or re-visit clincial development strategy