Pre-Clinical Toxicology & Safety Services
Post pre-clinical phase of drug development, the questions that arise are critical for each drug program. These questions directly relate to preparedness towards human clinical trials and enables the design of trials to allow adequate benefit-risk profiles for normal healthy volunteers as well as patients.
The questions that typically come up are:
Safety and Tolerability
- What is the Maximum Tolerated Dose (MTD) in animals?
- What is the no-effect dose in animals?
- Has the target been engaged?
- Does the engagement of the target show a biological response?
- Can an early proof of concept using the drug in a specific indication be identified?
At FlowMetric, to answer some of the above questions for our partners, we perform assays that:
- Identify changes in the number and percentage of cell types before and after treatment (Cell Phenotype).
- Identify changes in biological (cellular) response before and after treatment by evaluating cell proliferation, cell signaling, cytokine secretion and other functional readouts.
- Identification of change in cellular signaling before and after treatment.
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