Proprietary Quantitative Preclinical and Clinical Sciences Case Studies

View Praedicare's case studies utilizing proprietary and innovative Quantitative Preclinical and Clinical Sciences.

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Standard PK / PD Modeling and Simulation Case Studies

View Praedicare's case studies utilizing standard PK/PD modeling and simulation


Quantitative Clinical Forecasting from Preclinical Data

We use advanced mathematical models, category theory, quantitative outputs from customized wet lab tools, artificial intelligence and pharmacometrics for an integrated output to make quantitative clinical predictions using data generated early during preclinical stages.

Our quantitative predictions de-risk the drug development process by:

  • Shortening drug development
  • Helping make informed early decisions on compounds/leads to continue or stop developing
  • Develop diagnostic biomarkers and algorithms for adaptive trials reducing the numbers of patients in clinical trials and the duration of treatment for these patients volunteering for clinical trials

Our integrated modeling team consists of medicinal chemists, engineers and physicians – our primary aim during the preclinical stage of drug development is early transition to the clinic for both adults and children.

Our approach is a winning formula for clients

  • We pioneered many of these approaches
  • We wrote the original models (and the corresponding code)
  • We authored and created SOPs
  • We have used these approaches multiple times

Praedicare is a world-renowned leader in the standard PK/PD modeling and simulation, with combined expertise of greater than a century. Praedicare was part of writing the book. Here are some of Praedicare's PK/PD publications (out of many) spanning 3 decades.

Quantitative Preclinical and Clinical Sciences

  1. Morphism mapping and category theory from preclinical models to patients to identify response trajectories & therapy duration
  2. Development of biomarkers for clinical response outcomes from preclinical models using Morphism mapping
  3. Pediatric maturation pharmacology using integrated approaches with sui generis multiscale systems modeling from the level of cellular chemical reactions such as Michaelis-Menten reaction kinetics constructed de novo based on serum/plasma PKs, the child’s genome, to whole body physiological and age/sex parameters to model drug PKs
  4. Mathematical mapping of drug concentrations across organs, lesions and 3D space using dynamical sink models
  5. Modeling to map hundreds of physiological pathways and complex adaptive systems using multipl ‘omics across organs, 3D disease lesions and histopathological space using dynamical sink models and simulations for design of vaccines and therapeutics
  6. Use of machine learning algorithms to identify PK covariates & use of fractals obese patients
  7. Use of machine learning algorithms and clinical trial data to identify clinical MIC/resistance breakpoints
  8. Use of AI to deconvolute the effect & concentration thresholds associated with optimal efficacy of component drugs in combinations
  9. Use of AI and clinical trial data to identify optimal doses for efficacy & concentration thresholds associated with toxicity

Standard PK/PD Modeling and Simulation

  1. Candida glabrata Fungemia. Clinical features of 139 patients
  2. Anidulafungin pharmacokinetics and microbial response in neutropenic mice with disseminated candidiasis
  3. Once-weekly micafungin therapy is as effective as daily therapy for disseminated candidiasis in mice with persistent neutropenia
  4. Pegylated interferon fractal pharmacokinetics: individualized dosing for hepatitis C virus infection
  5. Integrating pharmacokinetics, pharmacodynamics and pharmacogenomics to predict outcomes in antibacterial therapy
  6. A program to create short-course chemotherapy for pulmonary Mycobacterium avium disease based on pharmacokinetics/pharmacodynamics and mathematical forecasting
  7. Pharmacokinetic-Pharmacodynamic and Dose-Response relationships of antituberculosis drugs: Recommendations and standards for industry and academia
  8. An oracle: Antituberculosis pharmacokinetics-pharmacodynamics, clinical correlation and clinical trial simulations to predict the future
  9. Levofloxacin pharmacokinetics/pharmacodynamics, dosing, susceptibility breakpoints and artificial intelligence in the treatment of multi-drug tuberculosis

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