Altasciences

Toxicity studies during drug development are essential. They play a vital role in helping drug sponsors make informed decisions. Your organization wants tests supporting data-driven decision-making to help move your drug development further along toward manufacturing and clinical trials. Your CRO partner can leverage the preclinical data in planning for and designing your first in human clinical trials . Here are six things you need to know before starting repeat-dose toxicity testing.  How Long Does a Repeated-Dose Toxicity Test Take? Once the design of the repeated-dose toxicity test is finalized, the tests usually range from 2 to 6 weeks. Using bioanalysis to identify biomarkers and other key translational endpoints during preclinical toxicology studies can help reduce the risk to clinical study participants and greatly benefit your research. It helps to have a team well-versed in selecting species, treatment group size, frequency, duration of treatment, administrati...

If your organization is developing a drug for the first time, you may not know the required regulatory phases. Each is essential to the drug development cycle and regulatory acceptance prior to taking a drug to market. If this is the first time your organization is on its way to first in human clinical trials , whether you are partnering with a contract research organization or not, here is all the most important information you need to know.  The Preclinical Phase The preclinical phase occurs before clinical trials can begin. Researchers must conduct laboratory research and present results to the FDA. The FDA then evaluates and potentially approves the results, paving the way for the clinical trial to begin in earnest. In this phase, regulatory approval is key. If your organization has not submitted results and procedures for regulatory approval in the past, partnering with a CRO with experience may be worthwhile. Phase 1: Safety The first phase of a clinical stud...