Nonclinical Efficacy Testing » Non-Clinical CROs and Agencies » Biotoxtech Co.,Ltd.

Biotoxtech Co.,Ltd.

Table of Contents
Table of Contents

Biotoxtech Co.,Ltd. is a Korean CRO(contract research organization) specializing in safety studies. The company conducts GLP-compliant non-clinical studies covering toxicity, efficacy, and pharmacokinetics. Biotoxtech operates as a direct research partner, providing contract research services without intermediaries or agents.

Features of Biotoxtech Co.,Ltd.’s Non-Clinical Testing Services

Efficacy evaluation services for disease-specific in vitro and in vivo models

Biotoxtech Co.,Ltd. has established both in vitro and in vivo models for efficacy evaluation across a wide range of disease areas, including diabetes, hypertension, dementia, osteoporosis, and liver disease.
In addition to pharmaceuticals, the company supports the acquisition of various data required for functional evaluation and regulatory approval of health foods and cosmetics.

Biotoxtech Co.,Ltd. is well-versed not only in Korean regulations but also in international guidelines and global research trends, maintaining a comprehensive non-clinical evaluation system to meet diverse client needs.

Support for juvenile animal model studies in pediatric drug development

Another distinctive feature of Biotoxtech Co.,Ltd. is its capability to conduct non-clinical safety studies using juvenile animal models.
For the evaluation of growth, development, motor activity, cognition, and toxicokinetics in pediatric drug development, the company have various established study protocols, which are corresponding to human developmental stages from birth to over 21 days of age.

Their ability to accurately capture the unique physiological responses of pediatric populations—distinct from those of adults—is one of Biotoxtech Co.,Ltd.’s key strengths.

Extensive GLP certifications and proven track record in Korea

Biotoxtech Co.,Ltd. has obtained multiple GLP certifications from Korean authorities, including the Ministry of Food and Drug Safety, the National Institute of Environmental Research, and the Rural Development Administration.
With extensive experience in toxicology, pharmacology, and metabolic studies, Biotoxtech is a highly reliable partner for companies seeking robust, reproducible non-clinical data.

Example of Biotoxtech Co.,Ltd.’s Disease Models

Diabetes model (in vitro / in vivo evaluation models for diabetes)

Biotoxtech has developed in vitro and in vivo preclinical models for diabetes, enabling comprehensive evaluation of candidate compounds through analyses of glucose regulation mechanism, insulin sensitivity, and improvements in glucose metabolism.

In addition to diabetes, the company also offers multiple experimental models and disease progression models that generate high-quality, reliable data for pharmaceutical drugs and functional materials.

Reference: Biotoxtech Co.,Ltd.( http://jpn.biotoxtech.com/pageLink.do?baseMenuNo=9910000&menuNo=9912100)

Biotoxtech Co.,Ltd. Non-Clinical Case Study

PK/TK Combined Pharmacokinetic and Toxicokinetic Study (Simultaneous Evaluation of Efficacy and Safety)

This integrated study evaluates the absorption, distribution, metabolism, and excretion (PK) of drug candidates, as well as the kinetics of toxicity onset (TK).
By analyzing both toxicity and efficacy with a focus on blood concentration—and utilizing advanced analytical techniques such as HPLC, LC/MS, and LC/MS/MS—Biotoxtech Co.,Ltd., they can deliver precise, reliable, and regulatory-compliant data.

Reference: Biotoxtech Co.,Ltd.( http://jpn.biotoxtech.com/pageLink.do?baseMenuNo=9910000&menuNo=9913100)

Biotoxtech Co.,Ltd. Company Information

Address53, Yeongyudanji-ro, Yanggok-eup, Cheongwon-gun, Cheongju-si, Chungcheongbuk-do, Korea
Tel+82 43-210-7777
Websitehttp://jpn.biotoxtech.com/

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