1. SNMMI Clinical Trials Network Research Series for Technologists: Clinical Research Primer—Use of Imaging Agents in Therapeutic Drug Development and Approval
2. Efficacy guidelines. ICH website. https://www.ich.org/page/efficacy-guidelines. Accessed November 30, 2022.
3. Members and observers. ICH website. https://www.ich.org/page/members-observers. Accessed November 30, 2022.
4. Good clinical practice. Food and Drug Administration website. https://www.fda.gov/about-fda/center-drug-evaluation-and-research-cder/good-clinical-practice. Updated December 11, 2019. Accessed November 30, 2022.
5. Part 312: investigational new drug application. Code of Federal Regulations website. https://www.ecfr.gov/current/title-21/chapter-I/subchapter-D/part-312. Updated November 28, 2022. Accessed November 30, 2022.