14C-radiolabeled (radiocarbon) drug studies are central to defining the disposition of therapeutics in clinical development. Concerns over radiation, however, have dissuaded investigators from conducting these studies as often as their utility may merit. Accelerator mass spectrometry (AMS), originally designed for carbon dating and geochronology, has changed the outlook for in-human radiolabeled testing.
Marijuana Effect on Differentiating an Opioid from Placebo During the Discrimination Phase of a Human Abuse Potential Study
Subjects of human abuse potential (HAP) studies must be able to detect liking with the investigational drug. However, many subjects recruited for HAP…
The Fundamentals of Human Abuse Potential (HAP) Studies: A 7-Point Checklist
Improving the science of abuse assessment before a drug is marketed is a unified goal for the FDA and pharmaceutical industry. It is the hope that…
Clinical Trials in Children with Impaired Mental Capacity
Download this resource to learn how to conduct studies with patients who lack legal competence and the 4 ethical pillars of medical research.