Nonclinical Efficacy Testing » Non-Clinical CROs and Agencies » New Drug Research Center

New Drug Research Center

Table of Contents
Table of Contents

Effective October 1, 2024, Shinyaku Research Center, Inc. and Anpaku Center, Inc. merged, and the merged entity changed its name to TransGenic, Inc.

Below is a description of the pre-merger information.

NDRcenter is a contract research organization with extensive experience in evaluating the pharmacological effects of pharmaceuticals. This page provides an overview of the company’s non-clinical capabilities, examples of disease models, and representative study cases. We hope you can use this information for a reference when selecting a CRO for your non-clinical needs.

Features of NDRcenter’s Non-clinical Contract Services

High-Quality GLP-Compliant Studies

NDRcenter provides GLP(Good laboratory Practice) non-clinical studies. This ensures clients with highly reliable data. The company offers a wide range of safety study in general toxicity, reproductive/developmental toxicity studies. These rigorous safety evaluation are essential during the development of pharmaceutical drugs and medical devices.

Broad Study Capabilities and Flexibility

NDRcenter provides a wide range of non-clinical studies in pharmaceutical drugs, medical devices, and foods. They are particularly known for their flexibility in handling a variety of safety studies —such as skin sensitization and cytotoxicity assays —they will provide an efficient, one-stop-for-all service for a variety of study types.

Specialized Testing and Analytical Expertise

They offer biochemical testing and histopathological evaluation with the team of experienced specialists. The company also has a dedicated quality assurance department to ensure the delivery of accurate and reliable data: detailed analysis and in-depth evaluation that is tailored to each client’s research needs.

Examples of Disease Models Available at NDRcenter

It is essential to go through the testing of candidate compounds in animal models that reproduce the target disease before advancing to clinical trials.

However, clinically relevant disease models may not always exist, thus there are demands for animal models with strong clinical correlation.

Below are some examples of disease models offered at Ina Research.

UMAI-Luc Mouse (Stress Visualization Model)

This model carries the UMAI-Luc gene, in which luciferase acts as a reporter, enabling visualization of the translational induction of ATF4—a key regulator of stress-response gene expression. These mice serve as a valuable tool for time-course observation of stress responses.

ERAI-Luc Mouse (Endoplasmic Reticulum Stress Visualization Model)

This model uses luciferase as a reporter and allows visualization of endoplasmic reticulum stress caused by the accumulation of unfolded or misfolded proteins during protein synthesis. The ERAI gene enables luminescent detection of stressed cells.

Examples of Non-Clinical Studies Conducted by NDRcenter

Experimental Autoimmune Encephalomyelitis (EAE) Model

To establish a mice model of multiple sclerosis, antigen emulsions were injected subcutaneously at two sites, followed by intraperitoneal administration of PTX solution. Another PTX dose was given 22–26 hours later. After the initial PTX administration, mice received either vehicle or the test substance orally once daily. As a result, co-administration with the adjuvant successfully induced the EAE model.

Brain Microdialysis in Rats and Mice

Research in the central nervous system requires sophisticated techniques and evaluation systems. Using brain microdialysis in freely moving rats and mice, NDRcenter collected extracellular molecules and measured neurotransmitter release in the brain. This technique has been applied to assess fluctuations in neurotransmitters following administration of antidepressants and anxiolytics, as well as to evaluate changes in target substances under specific experimental conditions.

Company Information

NDRcenter is a CRO that conducts a wide range of studies in pharmaceuticals, medical devices, chemicals, foods, and other fields.

Address 1-7-1 Yurakucho, Chiyoda-ku, Tokyo
Tel 0120-34-0412
Website http://www.ndrcenter.co.jp/

3 Recommended Contract Research Organizations
for Non-Clinical Studies
— by Target goal and Expertise

In non-clinical development, the choice of contract research organization shapes the quality of the data and the time it takes to reach the next decision. Below, three CROs are introduced by the type of study they support: pharmacology (efficacy) studies, safety studies, and pharmacokinetic (PK/PD) studies. Each summary describes the services the company offers so that you can match a provider to your target and development objective.

Pharmacology (Efficacy) StudiesDisease-Relevant Models for
Translational Drug Evaluation
SMC Laboratories, Inc.
Reference: SMC Laboratories, Inc. official website (https://www.smccro-lab.com/)

SMC Laboratories, Inc.

SMC Laboratories is a specialized non-clinical CRO focused on in vivo pharmacology and efficacy studies using disease-relevant animal models, particularly in fibrosis, inflammation, metabolic diseases, and oncology.

Areas of Expertise
Disease-Relevant Model Portfolio

SMC Laboratories offers models covering the liver, lung, kidney, intestine, and oncology. Its portfolio includes the proprietary STAM™ model for MASH, fibrosis, and hepatocellular carcinoma.

Study Design Based on Target Biology

Study plans are developed around the target biology, mechanism of action, disease stage, and development objective. Pharmacological endpoints can be combined with histopathology, biomarkers, and disease-specific readouts.

Support from Target Validation to Proof of Concept

With experience from more than 1,000 studies for clients in 30 countries, SMC Laboratories supports programs from target validation and candidate selection through in vivo proof-of-concept studies.

Safety StudiesComprehensive Safety Assessment for
Preclinical Development
Charles River Laboratories
Reference: Charles River Laboratories official website (https://www.criver.com/)

Charles River Laboratories

Charles River provides non-clinical toxicology and safety assessment services for programs ranging from exploratory safety studies to IND-enabling development.

Areas of Expertise
General Toxicology Across Study Designs

Services include single- and repeat-dose toxicology, dose-range finding, and general toxicology studies across multiple species and administration routes.

Non-GLP and GLP Study Support

Charles River supports both non-GLP and GLP studies, allowing sponsors to progress from early safety characterization to studies intended for regulatory submissions.

Integrated IND-Enabling Safety Assessment

Toxicology studies can be integrated with toxicokinetics, clinical pathology, histopathology, and safety pharmacology to support interpretation and IND-enabling safety packages.

Pharmacokinetic (PK/PD) StudiesConnecting Drug Exposure with
Pharmacological Response
Inotiv
Reference: Inotiv official website (https://www.inotiv.com/)

Inotiv

Inotiv provides integrated PK/PD, DMPK, and bioanalytical services to characterize drug exposure and its relationship with pharmacological response.

Areas of Expertise
Pharmacokinetic Characterization

PK studies characterize exposure, half-life, clearance, and other pharmacokinetic parameters needed to understand how a candidate behaves in the selected model.

Exposure–Response Evaluation

Pharmacokinetic data can be combined with pharmacodynamic endpoints and bioanalysis to evaluate the relationship between drug exposure and pharmacological response.

Integrated DMPK and Development Support

Integrated DMPK, pharmacology, and safety information supports candidate comparison, dose selection, dosing-frequency optimization, and decisions about subsequent preclinical development.

By Therapeutic Area
Disease Animal Models
and Reviews
Proven Capability, Expertise and Track Record
Top 3 Non-Clinical CRO Services