Abstract
The ultimate goal of any facility involved in the preparation of radiopharmaceuticals should be the generation of products that are safe and effective. Although this is a fairly obvious statement and almost all nuclear medicine personnel and radiopharmaceutical chemists would affirm that they do this, they cannot always prove their assertion; the failure is evidenced by a lack of sufficient data, lack of proper validation, or lack of documentation.
This is a preview of subscription content, log in via an institution to check access.
Access this chapter
Tax calculation will be finalised at checkout
Purchases are for personal use only
Preview
Unable to display preview. Download preview PDF.
References
Alexoff, D.L., Fowler, J.S., and Gatley, S.J., 1991, Removal of the 2.2.2. cryptand (kryptofix 2.2.2.™) from 18FDG by cation exchange, Appl. Radiat. Isot. 42:1189.
Alexoff, D.L., Casati, R., Fowler, J.S., Wolf, A.P., Shea, C., Schlyer, D.J., and Shuie, C-Y., 1992, Appl. Radiat. hot. 43:1313.
Boothe, T.E. and Emran, A.M., 1991, The Role of High Performance Liquid Chromatography in Radiochemical/Radiopharmaceutical Synthesis and Quality Assurance, in: Radiopharmaceutical synthesis, quality assurance and regulatory control, A.M. Emran, ed. Plenum, New York.
Chaly, T. and Dahl J. Robert, 1989, Thin layer chromatographic detection of kryptofix 2.2.2 in the routine synthesis of [18F]2-fluoro-2-deoxy-D-glucose, Nucl. Med. Biol. 16:385.
Coenen, H.H., Pike, V., W. Stöcklin, and Wagner, R., 1987, Recommendation for practical production of [2–18F]fluoro-2-deoxy-D-glucose, Appl. Radiat. hot. 38:605.
DeSain, S., 1991, Drug, Devise, and Diagnostic Manufacturing, Interpharm Press, Inc., Buffalo Grove.
FDA Public Hearing, March, 1993, Regulatory approach to positron emission tomographic (PET) radiopharmaceuticals, Rockville, MD, Institute of Clinical PET, Arlington.
FDA, 1984, Nuclear Pharmacy Guidelines: Criteria for Determining When to Register as a Drug Establishment, Office of Compliance, Washington, D.C.
Ferrieri, R.A., Schlyer, D.J., Alexoff, D.L., Fowler, and Wolf, A.P, 1993, Direct analysis of kryptofix 2.2.2.in 18FDG by ga chromatography using a nitrogen-selective detector, Nucl. Med. Biol. 20:367.
Finn, R. and Boothe, T., 1991, Quality assurance considerations related to “in-house” radiopharmaceutical preparations utilizing positron emitting radionuclides, in: Radiopharmaceutical synthesis, quality assurance and regulatory control, A.M. Emran, ed., Plenum, New York.
Hamacher, K., Coenen, H.H., and Stöcklin, 1986, Efficient stereospecific synthesis of no-carrier-added [2–18F]fluoro-2-deoxy-D-glucose using aminopropylether supported nucleophilic substitution, J. Nucl. Med. 27:235.
International Organization for Standardization, ISO 9000: International Standards for Quality Management, 2nd, ed., Geneva, Switzerland.
Johnson, B.F., Sabourin, C.L., and Finn, R.D., 1993, Improving the purity of [F-18]2FDG preparations, J. Nucl. Med. 34:239P.
Namavari, M., Satyamurthy, N., and Barrio, J.R., 1993, Efficient removal of tin contaminants from the preparation of 6-[F-18]fluoro-L-DOPA and analogs, J. Nucl. Med. 34:238P.
Padgett, H.C., Schmidt D.G., Luxen, A., Bida, G.T., Satymurthy, N., and Barrio, J.R., 1989, Computer-controlled Radiochemical Synthesis: A Chemical Process Control Unit for the Automated Production of Radiochemicals, Appl. Radiat. hot. 40:433.
Pike, V.W., Waters, S.L., Kensett, M.J., Bateman, D., Considine, D., Turton, D.R., Luthra, S.K., Braby, F., Sha, A., and Silvester, D.J., 1991, Radiopharmaceutical production for PET: quality assurance practice, experience and issues, in: New trends in: Radiopharmaceutical synthesis, quality assurance and regulatory control, A. M. Emran, ed. Plenum, New York.
Tewson, T.J., 1983, Synthesis of no-carrier-added fluorine-182-fluoro-2-deoxy-D-glucose, J. Nucl. Med. 24: 718.
Tewson, T.J., 1989, Procedures, pitfalls, and solutions in the production of [18F]2-deoxy-f- fluoro-D-glucose: a paradigm in the routine synthesis of fluorine-18 radiopharmaceuticals, Nucl Med. Biol 16:533.
USP XXII, Supplement 1, p.2129, 1989, United States Pharmacopeial Convention, Inc., Rockville, MD.
Vera-Ruiz, H., Marcus, C.S., Pike, V.W., Coenen, H.H., Fowler, J.S., Meyer, G.J., Cox, P.H., Vaalburg, W., Cantineau, R., Helus, F., and Lambrecht, 1990, Report of an international atomic energy agency’s advisory group meeting on “quality control of cyclotron-produced radiopharmaceuticals”. Nucl Med. Biol 17:445.
Vora, M., Boothe, T., Finn, R., Kothari, P., Emran, A., Carroll, S. and Gilson, A., 1985, Multimillicurie preparation of 2-[18F]fluoro-2-deoxy-D-glucose via nucleophilic Displacement with fluoride-18 labelled fluoride, J. Labelled Compd. Radiopharm. 22:953.
Author information
Authors and Affiliations
Editor information
Editors and Affiliations
Rights and permissions
Copyright information
© 1995 Springer Science+Business Media New York
About this chapter
Cite this chapter
Boothe, T.E., Emran, A.M. (1995). Role of Current Good Manufacturing Practices in Establishment of Quality Assurance for in-House Radiopharmaceuticals. In: Emran, A.M. (eds) Chemists’ Views of Imaging Centers. Springer, Boston, MA. https://doi.org/10.1007/978-1-4757-9670-4_19
Download citation
DOI: https://doi.org/10.1007/978-1-4757-9670-4_19
Publisher Name: Springer, Boston, MA
Print ISBN: 978-1-4757-9672-8
Online ISBN: 978-1-4757-9670-4
eBook Packages: Springer Book Archive