PBPK and Mechanistic Model-based Solutions
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PBPK models represent the best of both worlds with a mechanism based assimilation of physiology and disease pathology with drug data. While integrating data into a mechanistic framework, PBPK models are great tools to generate simulated exposures and related response outcomes in a population for various clinically untested scenarios.
· PBPK is arguably the best tool for planning FIH dose and regimen, provide clinical rationale or de-risk clinical strategy
· PBPK models could be coupled as exposure-response, exposure-safety or exposure-population for strategic assessments
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, Bio-waivers, extrapolation to special populations etc.
Being mechanistic and modular in design, PBPK models are flexible and can be enhanced by linking with various other techniques
Disease progression models
Systems biology network
BioPharmaceutical performance assessments (Virtual BE)
PBPK models allow extrapolations of drug profiles to various Sub populations as well
Pediatric
Geriatric
Renal and Hepatic impaired
Translational Resarch require unique combination of skillsets. Works best when Invitro biology, Pharmacokinetics, Clinical pharmacology and formulation sciences are well integrated.
Our cross-domain expertise is synergised with the power of mathematical modeling and simulations. Our Mathematical modeling approach binds together various domains into an integrated system for making informed decisions.
We have spent good time evaluating how smaller Reserch teams can become effective in identifying and exploiting therapeutic opportuniteis without following traditional approaches.
Our expertise identifies us as Discovery and Development Scientists with hands on expertise.
We also do mathematical modeling, bringing the best of both worlds
Bio- simulations are useful to address various facets of clinical development
FIH Dose selection
Trial Design
Formulation selection or Optimisation
Dissolution Safe Space
Justification of Clinical strategy
exploring various "What if scenario's" enhancing the power of simulations
Synergising with Integration with ML and AI
A carefully curated approaach to utilize the best of available technologies for Literature search, summaries and code development enhancing productivity while isolated from intellectual property.
Novel and locally run Machine Learning (ML) tools imlemented for creative problem solving, pattern identification and analysis.
At Pleroo Research, we have been building mathematical models for more than a decade addressing various facets of NCE and formulation development. Our solutions are always cross functional involving thought patterns from clinical practice, clinical pharmacology, formulation science and regulatory. Solutions rooted in science but business relevant.
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