Clearance Assays & Toxicity Testing

Understand the onset, duration, and extent of toxic effects a drug candidate may produce at various doses with independent assessments of drug in vitro cytotoxicity and preclinical toxicology studies. Element problem solves and consults on next steps, drawing on a long history testing and formulating both biopharmaceuticals and medical devices.

Drug safety assessments are supported by fully integrating this work with an ADME toolkit, providing a full framework for DMPK-toxicology studies. Confirm molecular clearance in complex matrices from animal sources, including food with an expanded collection of residual and clearance assays, in addition to combined ADME-toxicology testing. Get a quote for clearance and toxicity testing today. 

In vitro cytoxicity testing

Make informed, key decisions to carry a candidate or formulation forward or not with toxicity data. Understand the molecular toxicity of candidate drugs and molecules with in vitro cytotoxicity assays, performed to the strict standards set forth by ISO 10993-5 cytotoxicity guidelines. Information on candidate cytotoxic concentration is provided, as well as any observable adverse cellular effects associated with your drug or formulation.

Lean on Element's breadth of expertise and opt to expand cytotoxicity testing to other potential risk areas in drug development, including pharmaceutical formulation, extractable and leachables, contaminant analysis, trace elements, and beyond.

In vitro cytotoxicity testing provides drug developers with insight into the effects of their drug candidate on living human cells. While extrapolation from in vitro to in vivo is not perfectly linear, molecules shown to be highly toxic on cultured humans cells tend to pose greater toxicity risks in patients. Interested in our in vitro cytotoxicity testing services? Start the conversation. 

Preclinical toxicology studies

Uncover potential organ failures or adverse effects that may translate to human patients with preclinical toxicology studies. Once drugs are administered and samples collected, drug developers submit sample collections to understand how living organisms respond to a range of drug concentrations delivered to living organisms using intended administration routes.

Receive the most complete view of drug toxicity, short of phase 1 and 2 trials when preclinical toxicology studies are combined with Element's in vitro cytotoxicity testing using human cells. Request a quote for preclinical toxicology studies today.

Note: Element does not have animal storage and care facilities. Animal samples can be tested and analyzed in preclinical toxicology studies only once sent to the toxicity testing lab.

Residuals and clearance assays

Measuring the presence of residual drugs and testing for molecular clearance is important for both clinical trials and food safety. While clinical trial clearance assays are a key aspect of our DMPK/ADME testing services, clearance assays are offered as a separate service for analyzing complex matrices from animal sources, particularly animal food products. As these residual drugs and chemicals can be detrimental to humans once consumed, we help determine whether residuals are present in the food product and whether they are below allowable abundance thresholds (e.g., safe harbor levels).

Food products, be it meat or milk, are tested to determine molecular residuals with outstanding precision and very low limits of detection. Interested in getting a quote? Get in touch with Element today.

The Element advantage

Measure the presence of residual drugs and test for molecular clearance with excellent precision and extremely low limits of detection - important exercises in clinical trial and food safety. While clinical trial clearance assays are a key aspect of Element's DMPK/ADME testing services, clearance assays are offered as a separate service for analyzing complex matrices from animal sources, particularly animal food products.

Since these residual drugs and chemicals can be detrimental to humans once consumed, we help determine whether residuals are present in the food product and whether they are below allowable abundance thresholds (like safe harbor levels). Need support determining product safety? Talk with a bioanalysis expert today.