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Safety Evaluation Technology

Nitto Denko is engaged in the development of products based on the application of polymer materials. These include transdermal pharmaceutics and other pharmaceutical products and wound-dressing materials and other medical devices and products.
As these products are used in direct contact with the human body, biological evaluations are applied to ensure their safety and efficacy.

For pharmaceutical products and medical devices, in order to design products that combine safety with efficacy, the safety of drugs, additives (e.g. adhesives), and other raw materials and the safety of the products is evaluated in accordance with GLP standards and with toxicity study guidelines.
For medical products, safety evaluation in line with the individual characteristics of the product is carried out with reference to the Product Liability Law.

Safety Evaluation of Pharmaceutical Products

Pharmaceutical products are subject to biological evaluation from the product design stage aimed at ensuring safety.

Drug screening
Product design for composition

In vitro
Drug permeability study

Study of drug transfer to skin

Screening for skin irritation
 

Product design for drug content and controlled release

Measurement of drug concentration in skin in experimental animals

Measurement of drug concentration in blood
Pharmacology studies

Safety studies

  • General toxicity study (single-dose toxicity, repeated-dose toxicity) (rat, mouse)
  • Mutagenicity studies (bacteria, cultured cells, rat, mouse)
  • Skin toxicity studies　　
    • Primary skin irritation, cumulative skin irritation studies (rabbit)
    • Skin sensitization study, phototoxicity study, photosensitization study (guinea pig)
    • Intracutaneous reaction study (rabbit)
Safety studies

Safety Evaluation of Medical Devices and Products

For wound-dressing materials, large first-aid bandages, surgical tape, and similar products, biological evaluation of safety and usefulness is carried out in line with the specific applications and characteristics of the product.

Safety Evaluation of Medical Devices and Products

  • General toxicity
    • Single-dose toxicity study (rat, mouse)
  • Skin toxicity
    • Primary skin irritation study (rabbit)
    • Skin sensitization study (guinea pig)
    • Intracutaneous reaction study (rabbit)
  • Cytotoxicity (cultured cells)
  • Biocompatibility study (rat, rabbit, etc.)
  • Wound-healing study (rat, rabbit, etc.)

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