INDs for PET molecular imaging probes-approach by an academic institution
| Autor: | Mosessian, Sherly, Duarte-Vogel, Sandra M, Stout, David B, Roos, Kenneth P, Lawson, Gregory W, Jordan, Maria C, Ogden, Amanda, Matter, Cheryl, Sadeghi, Saman, Mills, George Q, Schelbert, Heinrich R, Radu, Caius G, Czernin, Johannes, Couto, Marcelo, Phelps, Michael E |
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| Rok vydání: | 2014 |
| Předmět: |
Male
Investigational New Drug application Physiology Investigational Clinical Sciences Bioengineering Diagnostic Radiology FDA regulations Animals Humans Drug Approval United States Food and Drug Administration Cytarabine Academies and Institutes Drugs PET probes Cost-effective United States Rats Molecular Imaging Clinical trial Nuclear Medicine & Medical Imaging Molecular Probes Positron-Emission Tomography Biomedical Imaging Female Sprague-Dawley Biotechnology |
| Zdroj: | Molecular imaging and biology, vol 16, iss 4 Mosessian, S; Duarte-Vogel, SM; Stout, DB; Roos, KP; Lawson, GW; Jordan, MC; et al.(2014). INDs for PET Molecular Imaging Probes-Approach by an Academic Institution. Molecular Imaging and Biology. doi: 10.1007/s11307-014-0735-2. UCLA: Retrieved from: http://www.escholarship.org/uc/item/6jh269h0 |
| Popis: | We have developed an efficient, streamlined, cost-effective approach to obtain Investigational New Drug (IND) approvals from the Food and Drug Administration (FDA) for positron emission tomography (PET) imaging probes (while the FDA uses the terminology PET drugs, we are using "PET imaging probes," "PET probes," or "probes" as the descriptive terms). The required application and supporting data for the INDs were collected in a collaborative effort involving appropriate scientific disciplines. This path to INDs was successfully used to translate three [18 F]fluoro-arabinofuranosylcytosine (FAC) analog PET probes to phase 1 clinical trials. In doing this, a mechanism has been established to fulfill the FDA regulatory requirements for translating promising PET imaging probes from preclinical research into human clinical trials in an efficient and cost-effective manner. © 2014 The Author(s). |
| Databáze: | OpenAIRE |
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