Biomarkers of Safety

One key aspect where biomarkers of safety differ from those of efficacy is that they preferably predict rather than report the biological effect they are flagging. Thus the biomarker should ideally precede that biological effect either in dose (i.e., be detectable at doses below where the damage occurs) or in time

(be detectable perhaps after one dose when the damage requires repeated dosing). These biomarker characteristics would provide support and confidence to the clinician during dose escalation in early clinical trials or during the transition from single to multiple doses. During later clinical development, a predictive biomarker could monitor for onset in a patient who is beginning to develop toxicity perhaps after several months of drug use. In the absence of evidence that a biomarker can predict onset, an ideal biomarker of drug-induced toxicity would characteristically show detectable changes prior to any serious or irreversible tissue injury and would also show reversibility of the biomarker signal upon removal of the toxicological insult.

Project Management Made Easy

Project Management Made Easy

What you need to know about… Project Management Made Easy! Project management consists of more than just a large building project and can encompass small projects as well. No matter what the size of your project, you need to have some sort of project management. How you manage your project has everything to do with its outcome.

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