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IDEA TO IND

Toxicology and Safety Assessment

Ensuring Drug Safety from Concept to Clinic

In the intricate world of drug development, ensuring the safety of innovative drugs before they reach human trials is paramount. Toxicology and safety assessments are essential in evaluating potential risks and guiding safe and effective drug development. Nona Biosciences, with its extensive expertise and a wide range of GLP and non-GLP services, offers a robust framework to navigate these challenges.

Our Services


Early Stage Drug Candidate Selection

  • Identifying Potential Risks

Early identification of risky molecules or targets is crucial. This involves detailed data analysis based on mechanisms of action (MoA) and in vitro results.

  • Animal Species Testing

Selection of relevant animal species for testing.

  • Method Development

Includes biomarker and PK/PD detection.

  • Integrated Safety Testing

Incorporates safety assessments into early phase pharmacology studies.

Investigative Toxicity Assessment

  • De-risking Innovative Molecules

Early-stage investigational toxicity studies in vivo to make informed Go/No-Go decisions with minimal drug requirement and cost.

  • Animal Models Used
  • Rodent (mice, rats)
  • Transgenic mouse
  • Canines
  • Non-human primates (Cynomolgus).
  • Accreditation and Compliance

All animal studies are conducted in facilities accredited by the Association for Assessment and Accreditation of Laboratory Animal Care (AAALAC), ensuring high standards of animal welfare and ethical compliance.

Dose-Range Finding (DRF) Toxicity Study

  • Non-GLP DRF Studies

Non-GLP DRF studies are essential for informing decisions on moving forward with IND-enabling GLP toxicity studies.

  • Types of Studies
    • Dose Ranging/Maximum Tolerated Dose (MTD) Studies: Determine appropriate dosage levels.
    • Single Dose (Acute Toxicity) Studies: Identify potential adverse effects from a single dose.
    • Repeat Dose Studies: Evaluate effects of repeated administration over a defined period.
  • Routes of Administration
    • IV bolus/infusion
    • Subcutaneous
    • Intravenous
    • Oral (gavage/capsule)
    • Topical
    • Intramuscular
    • Intradermal
    • Ocular
    • Implant
    • Other routes upon request
    • IV bolus/infusion
    • Subcutaneous
    • Intravenous
    • Oral (gavage/capsule)
    • Topical
    • Intramuscular
    • Intradermal
    • Ocular
    • Implant
    • Other routes upon request

Full GLP Compliance Toxicity Study

  • GLP Toxicity Studies

Complete GLP compliance toxicity studies are conducted in accordance with FDA, OECD, and NMPA guidelines, supporting IND submissions for various species including rodents, canines, and monkeys.

Translational Safety and Efficacy Biomarkers

  • Biomarker Development

Design, develop, and implement translational safety and efficacy biomarkers for both nonclinical and clinical safety studies.

Advantages of Using Nona Biosciences’ Toxicity Services

  • Timeline Saving

Save over three months compared to average CRO study schedules.

  • Economic Efficiency

Achieve greater financial efficiency with our competitively priced services.

  • Regulatory Compliance

Meet US/EU/China GLP requirements and ICH/FDA guidelines.

  • Animal Welfare

Partner with CROs certified by global animal welfare agencies and an independent IACUC committee.

  • Study Monitoring and Management

Provide real-time study design, data interpretation, quality control, documentation, and reporting.

  • Logistics

Utilize qualified shipment providers for secure tracking and fast customs clearance.

Nona Biosciences’ nonclinical Toxicology and Safety Assessment services are designed to streamline the drug development process, offering significant time and cost savings while ensuring regulatory compliance and high standards of animal welfare. With expert leadership and comprehensive service offerings, Nona Biosciences supports the successful transition from drug candidate selection to IND submission.

FAQs

1. What are nonclinical toxicology and safety assessments?

Nonclinical toxicology and safety assessments involve evaluating potential safety risks of new drug candidates through various studies before they are tested in humans.

2. Why are nonclinical toxicology and safety assessments important?

These assessments help ensure that drugs are safe for initial human use, protecting public health and aiding in regulatory approval processes.

3. What types of studies are included in nonclinical toxicology and safety assessments?

Studies include early-stage drug candidate selection, investigative toxicity assessment, dose-range finding studies, and full GLP compliance toxicity studies.

4. How does Nona Biosciences ensure compliance with regulatory guidelines?

Nona Biosciences adheres to US, EU, and China GLP requirements and ICH/FDA guidelines, providing comprehensive regulatory and technical support.

5. What animal models are used in nonclinical safety assessments?

Common animal models include rodents (mice, rats), transgenic mice, canines, and non-human primates (Cynomolgus).

6. How can Nona Biosciences’ services benefit drug developers?

Nona Biosciences offers significant time and cost savings, expert regulatory and technical guidance, and a commitment to ethical research practices, making them a valuable partner in drug development.

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