1、High Drug Development Failure Rate? Non-GLP Pharmacological and Toxicological Studies Accelerate Preclinical Decision-Making and Reduce R&D Risks

• Industry Pain Point: Traditional drug development often faces high failure rates in later stages due to toxicity or efficacy issues, resulting in significant time and cost inefficiencies.
• Value Proposition: Utilizing a customized and efficient non-GLP study platform, we enable rapid assessment of drug safety and efficacy, shortening the R&D cycle by 30% and delivering key data to support IND submissions.

2、Service Overview

A Crucial Phase in Preclinical Drug Safety and Efficacy Evaluation

• Positioning: Non-GLP pharmacological and toxicological studies serve as a pivotal stage prior to clinical trials, focusing on drug safety (acute/chronic toxicity) and pharmacodynamics (PD/PK) assessment.
• Industry Pain Point: Traditional methodologies are often time-consuming, costly, and struggle to accurately simulate human responses.
• Core Objective: By leveraging standardized animal models and a multidimensional testing platform, we deliver highly predictive data to reduce the risk of clinical failure.

3、Our Services

By Research Phase and Application Scenario: Covering Full-Process Needs

• Acute Toxicity Study
  • Application: Single-dose safety assessment.
  • Key Endpoints: Animal behavioral observation, blood biochemistry (AST/ALT), histopathology (H&E staining).
• Chronic Toxicity Study
  • Application: Repeat-dose toxicity (4-13 weeks).
  • Key Endpoints: Body weight changes, organ coefficients, hematology, histopathology.
• Pharmacokinetic (PK)/Pharmacodynamic (PD) Studies
  • Techniques: Quantification of plasma drug concentrations and tissue drug levels via High-Performance Liquid Chromatography (HPLC), determination of pharmacokinetic parameters including half-life (T₁/₂) and clearance (CL).

4、Technology Platforms and Advantages

GLP-Aligned Technology System Ensuring Data Reliability

• Technology Platforms
  • Flow Cytometry Platform: Detection of cell apoptosis, cycle, and inflammatory cytokines (TNF-α, IL-6).
  • Molecular Detection Platform: qPCR, WB.
• Infrastructure
  • SPF-Grade Animal Facility: Capacity for 5,000 mouse/rat cages, compliant with AAALAC standards.
  • BSL-2 Laboratory: Supports pathogen infection models (e.g., Staphylococcus aureus endocarditis).
• Differentiated Advantages
  • Matrix Resources: 300+ PDX sample library, 1,000+ cell lines, enabling multi-dimensional model construction.
  • Cross-Species Models: Full coverage of mouse, rat, and rabbit models.

5、Service Process

Transparent Collaboration with 48-Hour Rapid Response

• Requirement Communication: Provide tailored proposals within 24 hours, clarifying models, testing indicators, and timelines.
• Experimental Execution: Share progress in real time (VR mini-program oversight) and visualize data at key milestones.
• Data Delivery: Deliver comprehensive reports within 7–10 business days, including raw data, statistical analysis, and pathological section images.

6、Quality Control and Compliance

GLP-Aligned Standards with Data Traceability

• Compliance Standards: Experimental designs adhere to FDA, EMA, and NMPA regulations, and execution follows GLP-aligned processes.
• Quality Control: Double-blind data review and third-party cross-validation (e.g., STR profiling for cell lines).
• Equipment Calibration: Regular maintenance of key equipment such as flow cytometers and HPLC systems.

7、Case Studies

Empowering Pharmaceutical R&D with Data-Driven Decisions

• Case 1: Repeat-Dose Toxicity Study of a Small-Molecule Drug
  • Process: A 28-day continuous dosing study in SD rats, conducted under a GLP-referenced project management system.
  • Result: The test substance demonstrated significant liver and kidney toxicity.
• Case 2: Efficacy Validation of an Anti-Infective Drug
  • Model: Staphylococcus aureus endocarditis rat model.
  • Result: The treatment group showed a 40% increase in survival rate and a 50% reduction in inflammatory cytokine (IL-1β) levels, as detected by flow cytometry.
  • View More Cases: Jennio Efficacy Evaluation Handbook.

8、Collaboration Advantages

One-Stop Solution Balancing Efficiency and Flexibility

• Customization: Tailored protocols for different drug types (small molecules/biologics), supporting projects from early screening to IND submission.
• Fast Turnaround: Acute toxicity studies completed in 10–15 business days, 30% faster than industry average.
• End-to-End Support: Integrated services covering model establishment, testing, and data analysis, reducing client coordination efforts.

9、FAQ

• Q1: Are cross species models supported?

A: Yes, we support customized models in mice, rats, rabbits, and non-human primates (NHPs).

• Q2:Is expedited data delivery available?

A: Expedited service is available (additional 30% fee), with delivery in as fast as 5 business days.

• Q3: Are special formulations (e.g., nanomedicines) supported?

A: We have expertise in toxicity assessment of nanocarriers (particle size/stability analysis).

10、Laboratory Highlights

Professional Facilities Ensuring High-Precision Output

• Automated Workstations: SPF animal housing equipped with workstations to maintain a sterile environment
• In Vivo Imaging Systems: Real-time monitoring of tumor growth
• View Laboratory Panorama:

View More

11、Contact Us

24-Hour Response, Free Consultation to Start Collaboration

• Email: 3691125803@qq.com
• : +86 18802035152
• Download booklet:Download Service Handbook at: https://www.jennio-bio.com/contact-us/
• Additional Resource: Whitepaper on Pharmacological and Toxicological Research.