Book chapter
Moving PET Drugs from the Lab to the Patient in the USA
Handbook of Radiopharmaceuticals, pp.491-499
John Wiley & Sons, Ltd
12/21/2020
DOI: 10.1002/9781119500575.ch15
Abstract
Positron emission tomography (PET) drugs are unique in that they are produced in small batches by decentralized manufacturers/pharmacies due to their physical characteristics, which do not lend them to large‐scale production: namely, the shorter half‐lives of positron‐emitting radionuclides. Through congressional action, specific legislative language was added to the Food and Drug Administration Modernization Act, which was signed by President Clinton in 1997. The use of research PET drugs in patients occurs under investigational new drug (IND) or Radioactive Drug Research Committee approval, while clinical PET drugs must be approved under an new drug application (NDA) or abbreviated new drug applications. The rules and regulations for INDs are found in 21 CFR Section 312. Of particular use is the exploratory IND (eIND) mechanism, which is a special type of IND. The content of an IND includes: clinical imaging protocol; chemistry, manufacturing, and controls; pharmacology and toxicology; and human experience with the investigational agent or related compounds.
Details
- Title: Subtitle
- Moving PET Drugs from the Lab to the Patient in the USA
- Creators
- David W Dick
- Contributors
- Peter Scott (Editor)Michael Kilbourn (Editor)
- Resource Type
- Book chapter
- Publication Details
- Handbook of Radiopharmaceuticals, pp.491-499
- DOI
- 10.1002/9781119500575.ch15
- Publisher
- John Wiley & Sons, Ltd; Chichester, UK
- Number of pages
- 9
- Language
- English
- Date published
- 12/21/2020
- Academic Unit
- Radiology; Pharmaceutical Sciences and Experimental Therapeutics
- Record Identifier
- 9984320088502771
Metrics
16 Record Views