Shokukanken Inc.

Shokukanken, Inc. (hereinafter referred to as “Shokukanken”) is among the few CROs in Japan specializing in veterinary drugs and conducts a large volume of contracted studies. This overview presents the features of its nonclinical studies, an example disease model, and representative case studies. It is intended as a reference when selecting a CRO for nonclinical studies.

Non-Clinical Studies at Shokukanken

High-quality safety, pharmacology, and pharmacokinetic studies

Shokukanken provides high-quality safety studies, drug efficacy/pharmacology studies, and pharmacokinetic studies in accordance with applicable guidelines. In the veterinary field, the organization conducts contracted studies as a contract research organization (CRO).

To apply for registration of veterinary drugs with Japan’s regulatory authorities, both clinical and nonclinical studies are required to address efficacy, safety, and quality control. Shokukanken supports new-drug development for food-producing animals and companion animals in accordance with GCP and GLP regulations.

In-house Non-Clinical testing and clinical collaborations

Shokukanken conducts nonclinical testing in in-house breeding facilities and performs clinical trials in collaboration with livestock farms. The organization also maintains a robust testing and analytical framework. Available analytical instruments include LC/MS, LC/MS/MS, GC/MS/MS, TOF-MS, and dissolution testers.

Shokukanken conducts programs spanning nonclinical studies, clinical studies, and postmarketing use-results surveys for veterinary drugs. In addition, the organization undertakes veterinary pharmaceutical affairs and consulting services related to marketing authorization and re-examination.

Partner Companies associated with Shokukanken

Fuji Micra Co., Ltd.

Fuji Micra has independently developed ultra-small experimental pigs that weigh under 10 kg and measure less than 80 cm in length at six months of age—small enough to be housed in standard dog cages. Other disease models including atherosclerosis and chronic renal failure Micro Minipigs are available.

Hoku-shin Clinical Co.

Hoku-shin Clinical provides comprehensive contracted clinical laboratory services and consultation related to clinical testing and laboratory equipment, primarily in Nagano Prefecture. As a partner to regional medical institutions, the company supplies reliable clinical laboratory data through outsourced testing services.

Non-Clinical Case Studies — Shokukanken

Quality control testing

Testing is performed based on Attachment 2, “Guidelines for Application Materials for Approval of Veterinary Drugs,” within “Handling of Administrative Affairs Related to the Act on Quality, Efficacy and Safety Assurance of Drugs and Medical Devices.” Conducted test examples stipulated in the Standards for Biological Products for Veterinary Use include safety tests, potency tests, toxicity limit confirmation tests, adventitious virus–negative tests, sterility tests, characteristics tests, pH tests, and moisture-content tests.

Various toxicity tests

Development studies are conducted under appropriate information storage and management in accordance with GLP and ISO. Available services include toxicity tests and skin irritation tests. Supported species include medaka (for fish) and, among rodents, mice, rats, hamsters, guinea pigs, and rabbits.

Laboratory of food environment and hygiene (Shokukanken) Company Information

The company's strength lies in its proposals to create "one" from "zero" in business domains ranging from "farms" to "dining tables.