Clinical Pharmacology

Linking Truth Technology Co., Ltd. is a subsidiary of R&G, established in January 2018, and focuses on clinical pharmacology-related services. Linking Truth, led by clinical pharmacology experts Prof. Bei Hu and Dr. Ping Liu, has a high-level clinical pharmacology/quantitative pharmacology research team and currently has nearly 60 professionals. The team specializes in excavating the biological mechanisms associated with clinical observation data and using predictive and extrapolated quantitative science techniques in modeling and simulation to improve decision-making quality, R&D efficiency, and cost-effectiveness during drug development and lifecycle management. Company can customize the overall clinical pharmacology R&D strategy for customers and provide end-to-end clinical pharmacology support for the full lifecycle from the first-in-human trial of the product to the registration of new drugs and post-marketing studies. The team has so far provided more than 400 clinical pharmacology/quantitative pharmacology services for clinical studies of innovative drugs, generic drugs, biosimilars, complex dosage forms and others to more than 100 customers at home and abroad, providing deliverables that meet NMPA, FDA, EMA, and PMDA standards. Linking Truth provides customers with high-quality clinical pharmacology-related services with adhering to the principle of data as the basis, science as the criterion.

Non-clinical to Clinical Transition Phase

Construct the overall clinical pharmacology strategy;

Dose prediction in first-in-human trial, dose selection basis, pharmacokinetic/pharmacodynamic (PK/PD) design and protocol writing.

 Early Clinical Development Phase (Phase 1)

Provide real-time analysis to guide dose escalation based on traditional clinical pharmacology study method (PK NCA analysis);

Support critical decisions (dose selection in phase 2, etc.) in new drug development based on quantitative pharmacology analytical methods (population PK modeling and simulation, PK/PD, dose-response relationship analyses);

Various traditional clinical pharmacology study designs, protocol writing, complete data statistical analysis, and CSR writing.

Late Clinical Development Phase (Phase 2/3, Post-Marketing Studies, Pediatric Indication Development)

PK/PD design and quantitative pharmacology analysis (population PK and PK/PD analysis, dose-response relationship analysis, C-QT analysis; supporting dose selection in phase 3, dose adjustment in special populations, pediatric dose extrapolation, etc.) in the clinical study protocol.

Registration Phase

Assist in the writing of IND, NDA/BLA and ANDA application dossiers, including CTD2.7.1, CTD2.7.2, CTD2.5, clinical pharmacology-related sections in the package insert, ethnic sensitivity analysis report, etc.;

Provide clinical pharmacology consultation for global registration application: pre-IND, pre-NDA/BLA attendance.