• Aquestive
  • Astellas
  • Axsome
  • 4B Technologies
  • Fudan-Zhangjiang
  • Ascletis
  • Haisco Pharmaceutical
  • Hisun Pharmaceutical
  • Hengrui Medicine
  • China Hinye
  • Gmax Biologics
  • Huadong Medicine
  • ComGen Pharma
  • Carephar
  • Livzon Pharmaceutical
  • Mabwell Biotech
  • MicuRx Pharmaceuticals
  • Otsuka Pharmaceutical
  • QR Pharmaceuticals
  • Humanwell Healthcare
  • CSPC Pharmaceutical
  • Forever Medicine
  • Beijing Hospital
  • Chance Pharmaceuticals
  • Jemincare
  • GenSci Pharmaceuticals
  • Kelun Pharmaceutical
  • Kelun-Biotech
  • InnoCare Pharma
  • Xihua Scientific
  • Kanova Biopharma
  • Impact Therapeutics
  • Peking Union Medical College Hospital
  • Wuxi People's Hospital
  • Shanghai University of Engineering Science
  • Wuhan Institute of Technology
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AI drug development
About B²O

Applying Artificial Intelligence
Integrated with computer modeling and simulation technologies
to guide clinical drug development, optimize or waive clinical trials, and accelerate new drug R&D

Adopting a problem-oriented approach, we deliver regulatory-compliant and practical overall strategies for clinical research of new drugs, and provide AI-driven clinical pharmacology and quantitative pharmacology research services to accelerate drug development.

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Scope of Business

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Clinical Trial Protocol Design
Clinical Trial Protocol Design
  • First-in-Human (FIH) Trial
  • 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
  • Timing and Strategy of Study Design
  • Customized Solutions by Drug Modality
  • Small Molecules and Biologics
  • Early- and Late-Stage Drug Development
  • Clinical Pharmacology Gap Analysis and Development Roadmap 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 Projects
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) Analysis
  • 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 Study Reports and Simulation Reports
  • Mechanistic Modeling and Sensitivity Analysis
  • PK/QTc Prolongation Analysis
  • Drug-Drug Interaction (DDI) Modeling
  • In Vitro-In Vivo Correlation (IVIVC) for Biopharmaceutical Development
  • Model-Informed Drug Development (MIDD) and Pediatric Dose Extrapolation Framework
Biological Software Development
Biological Software 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-driven clinical pharmacology and quantitative pharmacology, dedicated to advancing model-informed drug development.

Contact Information

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ICP License: Hu ICP No.2022000499