Nonclinical Toxicology

Nonclinical Toxicology

ShanghaiInnoStar Bio-Tech Co. Ltd. (also known as National Shanghai Center for New DrugSafety Evaluation and Research, NCDSER) is the earliest and the mostcomprehensive nonclinical toxicology CRO in China, and also the CRO with themost certificates.

>>Early Toxicity Screening
Earlytoxicity screening is an indispensable step in the drug development process. Earlytermination of compounds not worth developing can save a lot of manpower, materialresources and time. We offer our customers a full range of early toxicityscreening services including toxicity prediction using DEREK,early genetic and general toxicity studies, and a complet set of in-vitrocardiac toxicity assays.
>>General Toxicology
As a leadingnonclinical safety assessment CRO in China, we have more than 40-yearexperiences in this area and have evaluated hundreds of compounds for ourcustomers, including chemical drugs, biotechnology products, Chinese herbalmedicines and chemicals. Our toxicity team is experienced and skilled and ableto provide customers with accurate study design and dose selection to ensurethe smooth conduct of studies. Our team also has the capability to properlydeal with any unexpected situations in a timely manner. We comply with theinternational GLP regulations and make study designs according to different guidelinesand requirements for IND or NDA submission.
>>Genetic Toxicology
Genetic toxicity (mutagenicity) of drugs and chemicals are tested through the genetic toxicology study. We offer customers a complete set of the ICH standard combination and conform to the international GLP regulations. The study design meets the requirement of US FDA and EPA, ICH, OECD and CFDA guidelines. The ample historic database, experienced team and professional senior researchers can ensure us to offer customers a cost-efficient, time-effective and high quality of service. In addition to the ICH standard combination, we can also provide with the rapid and low-cost early screening of genetic toxicity.
>>Developmental & Reproductive Toxicology
Developmental andreproductive toxicology (DART) is an important part of the safety assessment ofpharmaceuticals and chemicals. Our DART team is extensively experienced andoffers a full set of DART studies in line with the requirement of US FDA andEPA, OECD and CFDA guidelines. All studies are conducted in compliance with theinternational GLP regulations.
>>Safety Pharmacology
The objective of safety pharmacology study isto discover any unexpected clinical safety-related pharmacological effects, toevaluate any adverse effects or pathophysiological responses observed in atoxicity study or a clinical trial, and to explore the mechanism of adverseeffects. We have an experienced team and labs equipped with advanced andcomplete imported instruments to offer customers a full set of safetypharmacology studies in line with ICH S7A and S7B guidelines and international GLP regulations.
>>Carcinogenicity Study
We have been taking the lead in China to carry out the carcinogenicity study and have accumulated a large number of toxicology background data.
>>Analysis and Bioanalysis
We offer customers the services of dose formulation analysis, bioanalysis and TK profiling, including the method transfer/development and validation, sample analysis/bioanalysis, and TK data analysis. We have an experienced professional team and advanced imported instruments. Studies conform to the international GLPs.
>>Immunogenicity Test
We have extensive experience in the immunogenicity study and offer a high quality of service. We are compliant with the international GLP regulations.
>>Clinical Pathology
The clinical pathology lab was accreditated by CAP (the College of American Pathologists) in June 2015, which marks the technology and management of our lab has been in the rank of world-class laboratories. The lab is equipped with advanced imported instruments such as automated hematology analyzer, flow cytometry, automated chemistry analyzer, automated coagulation analyzer, electrolyte analyzer, and urine analyzer. The experienced team can offer a high quality of service and establish/develop/validate analytical methods on a need basis. We comply with the international GLP regulations.
>>Pathology
Our experienced and skilled team has being focused on offering customers a high quality of toxicological pathology evaluation service. Our pathologists with JCVP (Japanese College of Veterinary Pathologists) and JSTP (Japanese Society of Toxicological Pathology) can ensure us to offer customers accurate pathology diagnosis, high quality of pathology reports and peer review reports. We have a complete set of advanced imported instruments and digital pathology diagnosis system for remote pathology diagnosis. We conform to the international GLPs. The species used in studies include mice, rats, guinea pigs, rabbits, dogs and NHPs.