The future of USP monographs for PET drugs

Journal of Nuclear Medicine

Volumn 54, Issue 3, 2013, Pages 472-475

  Schwarz, Sally ^a,b   Norenberg, Jeffrey ^b,c   Berridge, Marc ^b,d   Dragotakes, Stephen ^b,e   Hung, Joseph ^b,f   Link, Jeanne ^b,g   Mason, N Scott ^b,h   Mattmuller, Steve ^b   Nickel, Richard A ^b   Packard, Alan ^b,i   Paolino, Justin ^b,j   Petry, Neil ^b,k   Ponto, James ^b,l   Quinton, Timothy M ^b   Seifert, Katherine L ^b,m   Swanson, Dennis ^b,n   Weiner, Ronald E ^b,o   Zigler, Steven ^b,p  

^a WASHINGTON UNIVERSITY SCHOOL OF MEDICINE   (United States)

^b Society of Nuclear Medicine   (United States)

^c UNIVERSITY OF NEW MEXICO HEALTH SCIENCES CENTER   (United States)

^d UNIVERSITY OF ARKANSAS FOR MEDICAL SCIENCES   (United States)

^e BETH ISRAEL DEACONESS MEDICAL CENTER   (United States)

^f MAYO CLINIC   (United States)

^g UNIVERSITY OF WASHINGTON   (United States)

^h UNIVERSITY OF PITTSBURGH SCHOOL OF MEDICINE   (United States)

ⁱ BOSTON CHILDREN S HOSPITAL   (United States)

^j BRIGHAM AND WOMEN S HOSPITAL   (United States)

^k DUKE UNIVERSITY MEDICAL CENTER   (United States)

^l UNIVERSITY OF IOWA   (United States)

^m Seifert and Associates   (United States)

ⁿ UNIVERSITY OF PITTSBURGH   (United States)

^o Ron Weiner Services   (United States)

^p PETNET Solutions   (United States)

more..

Author keywords

[No Author keywords available]

Indexed keywords

3 METHYLSPIPERONE C 11; 6 FLUORODOPA F 18; AMMONIA N 13; CARBON MONOXIDE C 11; FLUMAZENIL C 11; FLUORODEOXYGLUCOSE F 18; METHIONINE C 11; RACLOPRIDE C 11; RADIOPHARMACEUTICAL AGENT; RUBIDIUM CHLORIDE RB 89; SODIUM ACETATE C 11; SODIUM FLUORIDE F 18; UNCLASSIFIED DRUG; WATER O 15;

ARTICLE; DRUG APPROVAL; DRUG CONTROL; DRUG MARKETING; DRUG RESEARCH; FOOD AND DRUG ADMINISTRATION; MEDICAL LITERATURE; POSITRON EMISSION TOMOGRAPHY; PRIORITY JOURNAL; PUBLICATION; REIMBURSEMENT; STANDARDIZATION; UNITED STATES;

DRUG COMPOUNDING; DRUGS, INVESTIGATIONAL; HUMANS; LEGISLATION, DRUG; PHARMACOPOEIAS AS TOPIC; POSITRON-EMISSION TOMOGRAPHY; RADIOPHARMACEUTICALS; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 84874897596     PISSN: 01615505     EISSN: None     Source Type: Journal    
DOI: 10.2967/jnumed.112.115089     Document Type: Article

References (7)

1. U.S. Food and Drug Administration. Food and Drug Administration Modernization Act of 1997: section 121. http://www.fda.gov/ RegulatoryInformation/Legislation/FederalFoodDrugandCosmeticActFDCAct/ SignificantAmendmentstotheFDCAct/FDAMA/FullTextofFDAMAlaw/default.htm#SEC. 121. Published January 7, 1997. Accessed November 29, 2012.
2. U.S. Pharmacopeial Convention. USP 22-NF 17, Fludeoxyglucose F 18 Injection. Rockville, MD: U.S. Pharmacopeial Convention; 1990:579-580.
3. Food and Drug Administration. Guidance for industry: CGMP for phase 1 investigational drugs. http://www.fda.gov/downloads/Drugs/ GuidanceComplianceRegulatoryInformation/Guidances/ucm070273.pdf. Published July 2008. Accessed November 29, 2012.
4. Food and Drug Administration. Guidance for industry: analytical procedures and methods validation [draft]. http://www.fda.gov/downloads/Drugs/. . ./Guidances/UCM122858.pdf. Published August 2000. Accessed November 29, 2012.
5. U.S. Pharmacopeial Convention. USP 32-NF 27, Validation of Compendial Procedures, 1225. Rockville, MD: U.S. Pharmacopeial Convention; 2009: 1-33.
6. Food and Drug Administration. Guidance: investigational new drug applications for positron emission tomography (PET) drugs [draft]. http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/ Guidances/UCM291573.pdf. Published February 2012. Accessed November 29, 2012.
7. Food and Drug Administration. Orange book. http://www.accessdata.fda.gov/ scripts/cder/ob/default.cfm. Updated November 16, 2012. Accessed November 29, 2012.