Carcinogenicity studies
The 6-month carcinogenicity study is a shorter-duration assay designed to provide early insisht into the tumorigenic potential of new pharmaceutical compounds. Often used in parallel with other toxicity studies or as a part of a weight-of-evidence strategy, it serves as a valuable tool for screening and prioritizing drug candidates during development. We offer GLP-compliant 6-month studies that deliver high-quality data quickly and efficiently helping you make informed decisions on the path to regulatory approval.
Preclinical regulatory CRO
Established – 2000
Typically performed in transgenic mouse models, such as Tg.rasH2, this assay enables rapid evaluation of carcinogenic potential using sensitive endpoints and shorter timeframes. It is often used as an alternative to 2-years studies under the ICH S1B testing paradigm when supported by a comprehensive toxicological and pharmacological data package. Main advantages of this model include a shorter study duration of approximately 26 weeks , the use of genetically modified animal models such as rasH2 or p53+/-, and the ability to detect early-stage carcinogenic effects with high sensitivity.
Pharmaceutical
Biotechnoly
Advanced Therapy Medicinal Products
Vivotecnia has a highly specialized bioanalytical unit that combines state-of-the-art technology with a multidisciplinary team of experts in regulated preclinical studies.
Our team helps you to select the optimal sutdy model and integrate data from prior toxicology to reduce unnecesary long-term testing.
In-house pathology team with experience in tumor diagnosis and grading, ensurign consistency and precision.
We guide clients in using 6-month sata within ICH S1B frameworks for possible waiver of the 2-year study when justified.
Digital SOPs, real time study tracking, and Provatins platform integration ensure full traceability and data integrity.
Looking to assess carcinogenicity without
committing to a 2-year study?
Our 6-month carcinogenicity studies offer
a fast, reliable solution with full
regulatory relevance.
