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Drug Safety Evaluation Services

Drug safety evaluation refers to the evaluation of the safety of therapeutic drugs through laboratory studies and animal in vitro systems. With many years of experience in rare disease therapy research and a proven track record of quality, innovation, and customer support, our company provides comprehensive drug safety evaluation services to leading and emerging biopharmaceutical companies and scientific research institutions.

Overview of Drug Safety Evaluation

New types of drugs and new preparations are constantly emerging, and various safety issues are also arising. The purpose of drug safety evaluation is to determine the safe amounts and timing of drugs to avoid the occurrence of adverse events. Drug safety evaluation is a necessary procedure and an important step before new drugs enter final clinical trials and final approval. Traditional drug safety evaluation technologies and methods can no longer meet the growing needs. Research focuses on finding and establishing fast and accurate drug safety evaluation technologies and methods.

Applications of Drug Safety Evaluation

  • Discovery of the toxic dose
    Understand the toxic dose after a single administration, and initially understand the dose range that will produce toxic reactions when administered multiple times, which provides a basis for further toxicity studies and/or clinical study design.
  • Determination of safe dosage range
    Understand the dosage range within which the drug is effective without causing toxic side effects when administered single or repeatedly, providing information for clinical drug safety and observation of toxic and side effects.
  • Discovery of toxic target organs
    When toxic effects occur in animals, the organs or tissues involved in the toxicological effects of the drug are discovered, which provides a basis for monitoring the toxic and side effects of clinical drugs and modifying the structure of new drugs.
  • Determination of toxicity reversibility
    Understand whether the toxic effects of drugs on the body can be recovered, as well as the extent and time required for recovery, which provides a basis for further research on new drugs.

Our Services

As an integrated CRO, our company has the capabilities and resources to provide professional drug safety evaluation services to ensure that we can quickly respond to the changing needs of your rare disease research projects.

Genetic Toxicology Evaluation

  • Chromosomal Aberration Assay
  • Microwell Micronucleus Assay
  • Bacterial Mutation Assay

Immunogenicity and Immunotoxicity Evaluation

  • T-cell Dependent Antibody Response (TDAR)
  • Tissue Cross Reactivity (TCR)
  • White Blood Cell Differential Count

Phototoxicity Evaluation

  • Photoallergy Studies in Guinea Pigs
  • Photodynamic Drugs Evaluation
  • 3D Epidermal Cell Systems Evaluation

Tissue Cross-Reactivity Evaluation

  • Automated IHC Processing
  • Monoclonal Safety Evaluation
  • Slide Evaluation and Interpretation

Toxicokinetics Evaluation

  • TK/TOX Analysis
  • Metabolite Analysis
  • Immunogenicity Analysis
  • Microsampling for TK Profiling

Project Workflow

1-3-2 Drug Safety Evaluation Services-10

Why Choose Us?

With a research team with extensive expertise in drug safety evaluation, our company provides professional communication and problem-solving support to ensure that we can quickly respond to the changing needs of your rare disease therapy research projects. If you are interested in our services, please feel free to contact us for more information.

All of our services and products are intended for preclinical research use only and cannot be used to diagnose, treat or manage patients.

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