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AI drug development
About B²O

Leveraging Artificial Intelligence
integrated with computer modeling and simulation
to guide clinical drug development, optimize or waive clinical trials and accelerate new drug research & development

We adopt a problem‑oriented mindset to deliver regulatory‑aligned, practical overall strategies for new drug clinical research. Our team provides AI‑enabled clinical pharmacology and quantitative pharmacology services to accelerate drug development programs.

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Service Scope

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Clinical Trial Protocol Design
Clinical Trial Protocol Design
  • First‑in‑Human (FIH) Trial Design
  • Phase I Single‑ and Multiple‑Ascending‑Dose (SAD/MAD) Trials
  • Phase II Trial Design & Dosing Regimen Optimization
  • Phase III Dosing Regimen Exploration
  • Translational Pharmacology and ADME Studies
  • Clinical Pharmacology Study Design
  • Study Timing and Strategic Planning
  • Customized Solutions by Drug Modality
  • Small Molecules and Biologics
  • Early‑ and Late‑Stage Drug Development
  • Clinical Pharmacology Gap Analysis & Development Roadmaps for Decision Support
  • IND to NDA/BLA/MAA Submission Support (Briefing Books, eCTD Modules 2.7.1 & 2.7.2)
  • iPSP and Pediatric Investigation Plan (PIP) for Phase 3 Programs
Pharmacokinetic Analysis
Pharmacokinetic Analysis
  • Non‑Compartmental Analysis (NCA)
  • First‑in‑Human Dose Selection
  • Allometric Scaling and Dose Projection
  • Dose Proportionality Assessment
  • Bioequivalence (BE) and Relative Bioavailability Analysis
  • Food Effect and Drug‑Drug Interaction (DDI) Evaluation
  • CDISC PC/PP/IS Domains and ADaM ADPC/ADPP/ADIS Datasets
  • PK Study Reports and Clinical Study Report (CSR) Support
Modeling and Simulation
Modeling and Simulation
  • Translational PK/PD Modeling
  • Population PK Dataset Curation and Exploratory Data Analysis
  • Population PK (PopPK) Modeling and Simulation
  • Exposure‑Safety and Exposure‑Efficacy (Exposure‑Response) Analysis
  • PopPK/PD Analysis Reports and Simulation Reports
  • Mechanistic Modeling and Sensitivity Analysis
  • PK/QTc Prolongation Risk Assessment
  • Drug‑Drug Interaction (DDI) Modeling
  • In Vitro‑In Vivo Correlation (IVIVC) for Biopharmaceutics
  • Model‑Informed Drug Development (MIDD) and Pediatric Dose Extrapolation Frameworks
Biological Software Development
Software Platform Development
  • AI‑PBPK Platform
  • Drug‑Drug Interaction (DDI) Simulator
  • Virtual Bioequivalence (VBE) Simulator
  • Inhaled Drug Product Simulator
  • Proton Pump Inhibitor (PPI) Simulator
  • Special Population Database

B²O Pharma is an innovative pharmaceutical R&D enterprise focusing on AI‑enabled clinical pharmacology and quantitative pharmacology, committed to advancing model‑informed drug development.

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