Nonclinical Services


Safety Studies

LSIM Safety Institute offers comprehensive safety assessment of pharmaceuticals, medical devices, cellular and tissue-based products, cosmetics, agricultural chemicals, food additives, food for specified health uses, drugs intended for animal use, and general chemicals, etc. in compliance with various GLP or other guidelines. We are experienced in administering through various administration routes such as oral, percutaneous, subcutaneous, intravenous, intramuscular, intraperitoneal, intratracheal, intracavity knee joint, etc. Our animal laboratory researchers have received qualifications of junior laboratory animal technician, senior laboratory animal technician, and JACL certified technician in addition to having highly reliable technique through abundant experience and the ability to perform quick and detailed analysis. For pathological examinations, our pathologists with specialized qualifications (JCVP and JSTP, etc.) provide an accurate diagnosis. For cellular and tissue-based products, we are able to offer various GLP-compliant single dose toxicity studies, repeated dose toxicity studies, and tumorigenicity studies (in vivo and in vitro).

LSIM Safety Institute is SEND* compliant which was mandated since December 2016 for FDA application. The SEND preparation function has been added to our safety system since 2018, which has made quick correspondence possible. In addition, we are collaborating with Fujitsu Limited who have a proven track record with SEND, and, as our global strategies, established a support system with UK’s Instem LSS Ltd. We have built a system that is able to respond to various patterns of SEND data material preparation (datasets, define.xml, and n SDRG**). Please feel free to contact us.

*: Standard for Exchange of Nonclinical Data
**: Study Data Reviewer’s Guides for Nonclinical Data

Our Service

  • 1.Single Dose Toxicity Study (Acute Toxicity Study)

  • 2.Repeated Dose Toxicity Study (Subacute and Chronic Toxicity Study)

  • 3.Carcinogenicity Study

    We are able to conduct oral and percutaneous dose carcinogenicity studies on rodents. With our abundant background data, we are able to more accurately evaluate study results. Please feel free to contact us about other possible administration routes.

  • 4.Inhalation Toxicity Study

    We are able to conduct inhalation studies of almost any test article including dust, mist, gas, smoking agent, etc. In addition to whole-body inhalation exposure, we are also able to conduct nose-only inhalation exposure that minimizes the use of valuable test article. We possess both gas chromatography and high performance liquid chromatography which allows us to measure accurate exposure levels. We are not limited to toxicity studies but are able to perform pharmacological experiments etc. by inhalation exposure. Please feel free to contact us about above and any other inquiries.

  • 5.Reproductive and Developmental Toxicity Study, Reproduction Toxicity Study, Teratogenicity Study

    We are able to conduct reproductive and developmental toxicity studies in compliance with various pharmaceutical, agricultural chemical and general chemical guidelines. We have the capability to conduct tests which correspond to various reproductive development processes. We also offer screening tests for reproductive toxicity and mechanism analysis.

    • 5.1ICH-I, II, III

    • 5.2Two-Generation Reproduction Toxicity Study

    • 5.3Combined Repeated Dose Toxicity Study with Reproductive and Developmental Toxicity Study

    • 5.4Reproductive and Developmental Toxicity Screening Test

  • 6.Irritation Study

    We have numerous achievements in topical irritation, phototoxicity and cumulative skin irritation studies while maintaining compliance with various guidelines. In addition, we are able to offer irritation studies by intrarectal, intravenous, or intramuscular administrations.

    • 6.1Primary Skin Irritation Study

    • 6.2Primary Eye Irritation Study

    • 6.3Cumulative Skin Irritation Study

    • 6.4Repeated Eye Irritation Study

    • 6.5Vascular Irritation Study

    • 6.6Muscular Irritation Study

    • 6.7Skin Irritation Study with Human 3-Dimensional Cultured Tissue Model

  • 7.Sensitization Study

    We are able to offer skin sensitization and photosensitization studies. Although there are numerous methods for these studies, we have a proven record in almost all of them. The option of mouse local lymph node assay (LLNA) is also available.

  • 8.Antigenicity Study

    We are able to offer active systemic anaphylaxis reaction studies (ASA reaction tests), Homo-PCA reaction studies, and Hetero-PCA reaction studies.

  • 9.Immunotoxicity Study

    Analyses of lymphocyte subsets and production of specific antibody are available. Furthermore, we are able to measure various cytokines by enzyme linked immunosorbent assay (ELISA) and electrochemiluminescence immunoassay (ECLIA).

  • 10.Phototoxicity Study

    • 10.1Skin/Systemic Phototoxicity Study

    • 10.2In vitro 3T3 NRU Phototoxicity Study

      This short term toxicity study detects toxicity of photoreactive substances with Balb/c 3T3 cells. We are able to conduct this study in compliance with OECD432 guideline, and, produce accurate reliable results owing to our abundant background data.

  • 11.Cytotoxicity Study

  • 12.Toxicity Study for Cellular and Tissue-Based Products

  • 13.Exploratory Toxicity

    We also take on various studies (non-GLP) during developmental stages. Please feel free to contact us about study design.

Contact Us

We provide information for clients concerning development of pharmaceuticals, agrichemicals, and chemical substances etc.
Please note and understand that we cannot respond to requests from competitors or free e-mail addresses.

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