Regulatory Strategies
and Safety
Assessment
Dose Escalation Study (DRF)

TriApex is ready to design a DRF study (Non-GLP) to rapidly evaluate the toxicology risks of your drug candidate and help you decide whether the program is suitable to move forward.

Service Advantages

1. Efficient

TriApex makes scientific design to promote the efficient initiation and implementation of the study, and accelerate the data collection and analysis.

2. Professional

TriApex is staffed by more than 100 experts and experimental technicians with rich experience in toxicology. We are ready to provide toxicity assessment protocols according to the requirements and work with sponsors to formulate key R&D strategy.

3. High-quality

TriApex conducts studies in GLP-certified facilities to ensure the integrity and reliability of the data, and effective data transformation in subsequent studies.

Service Capacities

TriApex is ready to rapidly evaluate the preliminary safety of drug candidate using a limited animals, and support the dose level or dose frequency design in subsequent GLP-compliant toxicology studies.

Applications

TriApex realizes rapid early molecular screening by formulating customized study protocols, and provides guidance for the design of subsequent nonclinical studies.

Project Experience

TriApex has completed more than 300 DRF studies of drugs including new chemical entities (NCEs), biologics, gene therapies to support the early druggability evaluation and provide reference for subsequent toxicology studies. 

In the case of one antibody-drug conjugate (ADC) candidate, we conducted a DRF study to investigate the safety characteristics of drug candidate at different drug antibody ratio (DAR), and the evaluation parameters included clinical observation, body weight, food consumption, clinical pathology. Through short-term research, we helped the sponsor to screen candidate molecules, made key R&D decisions, and promote drug candidate into the development phase.