Design and Construction of a Radiochemistry Laboratory and cGMP-Compliant Radiopharmacy Facility.

FDA guidelines air quality control cGMP cleanroom clinical testing quality control radiation shielding radiochemistry laboratory radiopharmaceuticals radiopharmacy translational research

Journal

Pharmaceuticals (Basel, Switzerland)
ISSN: 1424-8247
Titre abrégé: Pharmaceuticals (Basel)
Pays: Switzerland
ID NLM: 101238453

Informations de publication

Date de publication:
25 May 2024
Historique:
received: 01 05 2024
revised: 16 05 2024
accepted: 18 05 2024
medline: 27 6 2024
pubmed: 27 6 2024
entrez: 27 6 2024
Statut: epublish

Résumé

The establishment of a compliant radiopharmacy facility within a university setting is crucial for supporting fundamental and preclinical studies, as well as for the production of high-quality radiopharmaceuticals for clinical testing in human protocols as part of Investigational New Drug (IND) applications that are reviewed and approved by the U.S. Food and Drug Administration (FDA). This manuscript details the design and construction of a 550 ft

Identifiants

DOI: 10.3390/ph17060680 PMID: 38931348
pubmed: 38931348
pii: ph17060680
doi: 10.3390/ph17060680
pii:
doi:

Types de publication

Journal Article

Langues

eng

Auteurs

Angela Asor (A)

Institute for Quantitative Health Science and Engineering, Michigan State University, East Lansing, MI 48824, USA.
Department of Chemistry, Michigan State University, East Lansing, MI 48824, USA.
ORCID: 0009-0001-0691-2989

Abdullah Metebi (A)

Institute for Quantitative Health Science and Engineering, Michigan State University, East Lansing, MI 48824, USA.
Comparative Medicine and Integrative Biology, Michigan State University, East Lansing, MI 48824, USA.
Radiological Science Department, Taif University, Taif 21944, Saudi Arabia.

Kylie Smith (K)

Institute for Quantitative Health Science and Engineering, Michigan State University, East Lansing, MI 48824, USA.
Department of Radiology, Michigan State University, East Lansing, MI 48824, USA.

Kurt Last (K)

WorkingBuildings, Atlanta, GA 30309, USA.

Elaine Strauss (E)

WorkingBuildings, Atlanta, GA 30309, USA.

Jinda Fan (J)

Institute for Quantitative Health Science and Engineering, Michigan State University, East Lansing, MI 48824, USA.
Department of Chemistry, Michigan State University, East Lansing, MI 48824, USA.
Department of Radiology, Michigan State University, East Lansing, MI 48824, USA.
ORCID: 0000-0003-3098-3397

Classifications MeSH