INDs for PET molecular imaging probes - Approach by an academic institution

Molecular Imaging and Biology

Volumn 16, Issue 4, 2014, Pages 441-448

  Mosessian, Sherly ^a   Duarte Vogel, Sandra M ^a   Stout, David B ^a   Roos, Kenneth P ^a   Lawson, Gregory W ^a   Jordan, Maria C ^a   Ogden, Amanda ^a   Matter, Cheryl ^a   Sadeghi, Saman ^a   Mills, George Q ^b   Schelbert, Heinrich R ^a   Radu, Caius G ^a   Czernin, Johannes ^a   Couto, Marcelo ^a   Phelps, Michael E ^a  

^a UNIVERSITY OF CALIFORNIA   (United States)

^b PAREXEL INTERNATIONAL   (United States)

Author keywords

Clinical trial; Cost effective; FDA regulations; Investigational New Drug application; PET probes

Indexed keywords

DEOXYCYTIDINE KINASE; FLUOROARABINOFURANOSYLCYTOSINE F 18; NEW DRUG; RADIOPHARMACEUTICAL AGENT; UNCLASSIFIED DRUG; CYTARABINE; MOLECULAR PROBE;

ARTICLE; COST EFFECTIVENESS ANALYSIS; DOSIMETRY; DRUG APPROVAL; DRUG RESEARCH; DRUG SAFETY; FOOD AND DRUG ADMINISTRATION; HUMAN; MOLECULAR IMAGING; PHASE 1 CLINICAL TRIAL (TOPIC); POSITRON EMISSION TOMOGRAPHY; PRIORITY JOURNAL; REGULATORY MECHANISM; ANIMAL; DIAGNOSTIC USE; ECONOMICS; FEMALE; MALE; MOLECULAR PROBE; ORGANIZATION; SPRAGUE DAWLEY RAT; UNITED STATES;

ACADEMIES AND INSTITUTES; ANIMALS; CYTARABINE; DRUG APPROVAL; DRUGS, INVESTIGATIONAL; FEMALE; HUMANS; MALE; MOLECULAR IMAGING; MOLECULAR PROBES; POSITRON-EMISSION TOMOGRAPHY; RATS, SPRAGUE-DAWLEY; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 84904420514     PISSN: 15361632     EISSN: 18602002     Source Type: Journal    
DOI: 10.1007/s11307-014-0735-2     Document Type: Article

References (24)

1. Vallabhajosula S, Solnes L, Vallabhajosula B (2011) A broad overview of positron emission tomography radiopharmaceuticals and clinical applications: what is new? Semin Nucl Med 41:246-264
2. Harapanhalli RS (2010) Food and Drug Administration requirements for testing and approval of new radiopharmaceuticals. Semin Nucl Med 40:364-384
3. Final rule (21 CFR part 212): (2009) current good manufacturing practice for positron emission tomography drugs Fed Regist 74 (236),65409-65436
4. Guidance on current good manufacturing practice for positron emission tomography (2009) Fed Regist; 74 (236),65538-65539
5. Guidance for small business entities on current good manufacturing practice for positron emission tomography drugs; availability (2011) Fed Regist; 76 (151),47593-47594
6. Final rule (21 CFR 361.1): radioactive drugs for certain research uses (1975) Fed Regist; 40 (144),31298-31311
7. Guidance for industry and researchers on the radioactive drug research committee: human research without an investigational new drug application; availability (2010). Fed Regist; 75 (147),45130-45131
8. Suleiman OH, Fejka R, Houn F, Walsh M (2006) The radioactive drug research committee: background and retrospective study of reported research data (1975-2004). J Nucl Med 47:1220-1226 (Pubitemid 47544919)
9. Guidance for industry on exploratory investigational new drug studies; availability (2006). Fed Regist; 71 (10),2551-2552
10. Carpenter AP Jr, Pontecorvo MJ, Hefti FF, Skovronsky DM (2009) The use of the exploratory IND in the evaluation and development of 18 FPET radiopharmaceuticals for amyloid imaging in the brain: a review of one company's experience. Q J Nucl Med Mol Imaging 53:387-393
11. Final rule (21 CFR 50 and 56): protection of human subjects; informed consent; standards for institutional review boards for clinical investigations (1991). Fed Regist; 56 (117),28025-28032
12. Final rule (21 CFR 312.7): promotion and charging for investigational drugs (1987). Fed Regist; 52, 8831
13. Final rule (21 CFR 312): investigational new drug application (1987). Fed Regist; 52 (53),8831-8847
14. Guidance on investigational new drug applications for positron emission tomography drugs; availability (2012). Fed Regist; 77 (233),71802-71803
15. Final rule (21 CFR 58): good laboratory practice for nonclinical laboratory studies (1978). Fed Regist; 43 (247),59986-60025
16. Stabin MG, Sparks RB, Crowe E (2005) OLINDA/EXM: the second-generation personal computer software for internal dose assessment in nuclear medicine. J Nucl Med 46:1023-1027 (Pubitemid 43733519)
17. Shu CJ, Campbell DO, Lee JT et al (2010) Novel PET probes specific for deoxycytidine kinase. J Nucl Med 51:1092-1098
18. Staub M ES (2006) The role of deoxycytidine kinase in DNA synthesis and nucleoside analog synthesis. In: Peters GJ, ed. Cancer drug discovery and development: deoxynucleoside analogs in cancer therapy, pp 29-52
19. 18F-fluoro-beta- L-arabinofuranosyl)-5- methylcytosine PET. J Nucl Med 53:275- 280
20. Laing RE, Walter MA, Campbell DO et al (2009) Noninvasive prediction of tumor responses to gemcitabine using positron emission tomography. Proc Natl Acad Sci U S A 106:2847-2852
21. Phelps ME (2000) Positron emission tomography provides molecular imaging of biological processes. Proc Natl Acad Sci U S A 97:9226-9233
22. Yaghoubi SS, Couto MA, Chen CC et al (2006) Preclinical safety evaluation of 18 F-FHBG: a PET reporter probe for imaging herpes simplex virus type 1 thymidine kinase (HSV1-tk) or mutant HSV1-sr39tk's expression. J Nucl Med 47:706-715 (Pubitemid 46768473)
23. Abbruzzese JL, Grunewald R, Weeks EA et al (1991) A phase I clinical, plasma, and cellular pharmacology study of gemcitabine. J Clin Oncol 9:491-498
24. Schwarzenberg J, Radu CG, Benz M et al (2011) Human biodistribution and radiation dosimetry of novel PET probes targeting the deoxyribonucleoside salvage pathway. Eur J Nucl Med Mol Imaging 38:711-721