Carcinogenicity Testing

The objective of the carcinogenicity test is to observe test animals for a major portion of their life span for the development of neoplastic lesions during or after exposure to various doses of a test substance by an appropriate route of administration. The study is usually conducted using two species – rats and mice. The animals are dosed by oral, dermal or other parenteral routes based upon the expected type of human exposure.

Two years Carcinogenicity assay:

Advinus has over two decades of experience under OECD, FDA and ICH guidance and has completed 60 carcinogenicity studies with huge historical control data. Advinus has the largest animal vivarium used for carcinogenicity studies. Advinus has demonstrated high level of consistency and expertise required for carcinogenicity studies with highly skilled and experienced Study Directors and Pathologists who have been Peer Reviewed by Board Certified Pathologists from US, Europe and Israel.

Carcinogenicity studies using Transgenic rasH2 mice:

Recent concern on the part of US FDA on improving the efficiency of carcinogenicity has resulted in recommendation to conduct 26-week carcinogenicity studies in transgenic mice rasH2. Advinus is the only company in India who has conducted three carcinogenicity assays in Transgenic rasH2 mice.

Advinus Experience with Carcinogenicity studies:

Study Type	Total # of studies completed	Studies completed in last 5-yers

Carcinogenicity study in mice	21	2
Carcinogenicity study in rat	10	3
Combined Chronic Toxicity and Carcinogenicity study in rat	26	3
6-Month Carcinogenicity study in Transgenic rasH2 Mice	3	3

Total	60	11

Our carcinogenicity study protocols were approved by the Carcinogenicity Assessment Committee (CAC) of USFDA. All preclinical data at Advinus are handled through Provantis®. Digital Pathology services include efficient and validated in-house software packages for statistical analysis and interpretation of data. Advinus has the capability of submitting the data files to FDA, in format specified by the regulatory agency, for example, Standard for Exchange of Non-Clinical Data (SEND) format

Advinus Therapeutics Ltd.
#21 & #22 Phase II, Peenya Industrial Area
Bangalore 560058, India
Phone: +91-80-28394959 | +91-80-6655 2700
E-Mail: bd@advinus.com | www.advinus.com