The Shanghai location is pleased to announce an expansion of its general toxicology capabilities to include safety pharmacology studies, allowing our Asia-Pacific clients to more easily complete their IND requirements for CFDA regulations.
What are the new safety pharmacology offerings?
The general tox team in Shanghai is now capable of running cardiovascular safety studies with dogs, using DSI PhysioTel Digital L11 telemeters to monitor drug elicited effects on electrocardiograms and hemodynamic parameters, heart rate and blood pressure. They are also able to run neurological and respiratory studies in rat models.
Team members from Shanghai were trained in these experimental procedures by experienced safety pharm specialists from the Madison site. After several months of personnel training, beginning in June 2018, validation studies at the Shanghai site were completed in early 2019.
The new safety pharm offerings are GLP-compliant and can be included in IND submissions. Most importantly, the Shanghai team can run safety pharm studies that meet the different regulatory guidelines set by the FDA and CFDA concerning the number and gender of animals used in each study.
The nonclinical development team in Shanghai already offers a fully-accredited preclinical general toxicology program with carcinogenicity, acute and chronic toxicity studies. With the addition of safety pharm capabilities, we can now offer our local Chinese clients a full in-house IND package.
When will the safety pharmacology capabilities be available to clients?
The safety pharmacology models have received both their FDA and CFDA approval.
Interested in other Asia-Pacific development facilities and capabilities?
Check out the Aland Center for bioanalysis, labs and clinical trials.