Design of clinical trials.

  title={Design of clinical trials.},
  author={David Rollo and Sanjay Machado and Mauro Ceschin},
  journal={Seminars in nuclear medicine},
  volume={40 5},
Clinical trial design for nuclear medicine diagnostic imaging radiopharmaceuticals must include a design for preclinical safety studies. These studies should establish that the investigational product (IP) does not have a toxic effect. As a further requirement, radiopharmaceutical clinical trials include a human study (phase 1) that provides biodistribution… CONTINUE READING