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NMB Editor-in-CHIEF, William C. Eckelman's Commentary
Selected Presentations from Past Meetings
From Various Presymposium Workshops at ISRS 2015
[18F]fluoride and nucleophilic aromatic substitutions
Johannes Ermert, PhD
[18F]Fluoride and Nucleophilic Aliphatic Substitution
Andrews Katsifis, PhD
Molecular Imaging of Cancer
Jonathan McConathy, PhD
Successes and pitfalls in tracer development: Lessons learned from neuroinflammation, Bert Windhorst, PhD
Macromolecules and their labeling with fluorine-18
Frank Wuest, PhD
Radiolabeled peptides - Radiopharmacology
Frank Wuest, PhD
From the Pre-Symposium Workshop on the Production of Radiopharmaceuticals for Clinical and Research Uses at ISRS 2013
The European Perspective
Philip Elsinga, PhD, UMC Groningen, The Netherlands
The Asian Perspective (Japan and Korea)
Yasuhisa Fujibayashi, PhD, D.Med.Sci., National Institute of Radiological Sciences, Chiba, Japan
The U.S. Perspective
Sally W. Schwarz, MS, BCNP, Washington University at St. Louis, MO USA
Presentations from symposia prior to ISRS 2013
Targeted Imaging: the right radiolabeled probe for the right target for the right disease
William C. Eckelman, PhD
Graduate Training in Imaging Sciences at Washington University
Carolyn J. Anderson and Michael J. Welch
Reversing The Trend: Radiochemistry at the University of Missouri-Columbia
J. David Robertson, et. al.
The SRS provides the below links as a resource to members who would like to learn more about clinical regulatory requirements. However, providing these links should not be interpreted as complete endorsement of stated recommendations and procedures.
Japanese Guidelines for PET Clinical Research - in includes:
1. Guideline for production of PET RP (JSNM cGMP for PET Drugs)
2. Guideline for preclinical tests for PET RP
3. Guideline for clinical trial for PET RP.
~ Unfortunately, there is no English version of this document.
The European Association of Nuclear Medicine's Radiopharmaceutical Guidelines
1. FDA CGMP for PET Rule
2. FDA Guidance document
3. CMC Postapproval Manufacturing Changes To Be Documented
5. FDA Oversight of PET Drug Products - Q&A
6. IND Applications for PET Drugs
7. Sterile Drug Products via Aseptic Processing - CGMP
If you would like to recommend documents and links to add to the Regulatory Corner, please provide your suggestion(s) through the Contact page.
Radiosynthesis Database of PET Probes (RaDaP) is an online database for radiosynthesis of PET probes, published in peer-reviewed scientific journals. Learn more.
The Molecular Imaging and Contrast Agent Database (MICAD) is an online source of information on in vivo molecular imaging agents based on recommendations from the extramural community. Learn more