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Toxicology Study

Meeting the requirements of FDA/NMPA/EMA

One-time IND approval

Toxicology Study

Toxicology is an important part of drug development, which explore the damage of drugs to the body under certain conditions. It is forced to carry out before First in human Clinical trials by agencies, and play a critical role in risk identification and control in clinical. ProBio integrated high-quality resources to provide a variety of Preclinical studies for IND filling, including efficacy, PK studies and toxicology study (Non-GLP & GLP).

Screening& Drug Evaluation

In Vivo Efficacy

PK Study

Toxicology

CTP

IND

6 months

8 months

Normal Process

4 months

6 months

Probio Record

Oncology in vivo model

ADME/PK
TK/ADA
RO
Single dose Toxicity
Repeated dose Toxicity
Bioanalysis

IND filling Package

M2.4/M2.6/M4 Package
Briefing book/RCP
Pre-IND meeting slides
CTD Package
IND submission

Service Features

Meeting the requirement for GLP and Non-GLP
Meeting the requirement for IND filling from different agencies, like FDA, NMPA and EMA, etc.
High one-time IND approval rate
One-stop solution with CMC team

Service Package

Service package
1、Single dose toxicology study
2、Dose-response-finding study (DRF)
3、Repeated dose toxicology study
4、Topical toxicity study
5、Safety pharmacology study
6、Tissue cross reactivity
7、Immunotoxicity

Inquiry and order

Please download service quotation form and fill it before sending to us.