Safety Studies

Safety Studies

Mediford Corporation offers comprehensive safety assessment of pharmaceuticals, medical devices, cellular and tissue-based products, cosmetics, agricultural chemicals (including microbial pesticides), 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).

Mediford Corporation is SEND* compliant which was mandated since December 2016 for FDA application. The SEND preparation function has been added to our safety system since 2017, which has made quick correspondence possible. In addition, we are collaborating with corporation who have a proven track record with SEND, we have built a system that is able to respond to various formats of SEND data material preparation (datasets, define.xml, and n SDRG**). Please feel free to contact us.

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

Service Details

Single Dose Toxicity Study (Acute Toxicity Study)

Repeated Dose Toxicity Study (Subacute and Chronic Toxicity Study)

Carcinogenicity Study

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

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.

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.

ICH-I, II, III

Two-Generation Reproduction Toxicity Study

Combined Repeated Dose Toxicity Study with Reproductive and Developmental Toxicity Study

Reproductive/Developmental Toxicity Screening Test

Irritation Study

We have numerous achievements in topical irritation 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.

Primary Skin Irritation Study

Primary Eye Irritation Study

Cumulative Skin Irritation Study

Repeated Eye Irritation Study

Vascular Irritation Study

Muscular Irritation Study

Skin Irritation Study with Human 3-Dimensional Cultured Tissue Model

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.

Skin Sensitization Study

Skin Photosensitization Study

Antigenicity Study

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

Immunotoxicity Study

The immune system plays an important role in protection of the body by eliminating foreign pathogens such as bacteria and viruses, as well as tumors. When the balance of the immune system tends toward suppression, infectious diseases and tumors occur, and when it tends toward renewal, allergies and autoimmune diseases occur. Therefore, it is necessary to conduct immunotoxicity studies to determine whether the balance of the immune system has been disrupted by the test substance. 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).

Phototoxicity Study

Skin/Systemic Phototoxicity Study

In vitro 3T3 NRU Phototoxicity Study

This study is to determine the cytotoxicity of a compound activated by irradiation with light.
In vitro phototoxicity studies have good correlation with in vivo results and are considered effective in evaluating the phototoxicity of test substances.
Since we apply a cellular testing method (NR method) that uses neutral red uptake into cells as an indicator, we can obtain results with high sensitivity and reproducibility in a short period of time. We are able to conduct this study in compliance with OECD432 guideline using our abundant background data.

Cytotoxicity Study

Exploratory Toxicity

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