Conception, realization and qualification of a radioactive clean room lab facility dedicated to the synthesis of radiolabeled API for human ADME studies-Reference-Cited by-同舟云学术

Conception, realization and qualification of a radioactive clean room lab facility dedicated to the synthesis of radiolabeled API for human ADME studies

Published:2016-06-10 Issue:14 Volume:59 Page:611-614
ISSN:0362-4803
Container-title:Journal of Labelled Compounds and Radiopharmaceuticals
language:en
Short-container-title:J. Label Compd. Radiopharm

Author:

Loewe Claudia¹,Atzrodt Jens¹,Reschke Kai²,Schofield Joe³

Affiliation:

1. Sanofi R&D; DSAR-DD Isotope Chemistry and Metabolite Synthesis; Frankfurt Germany

2. Sanofi R&D; Site Quality Operations; Frankfurt Germany

3. Sanofi R&D; DSAR-DD Isotope Chemistry and Metabolite Synthesis; Vitry Sur Seine France

Publisher

Wiley

Subject

Organic Chemistry,Spectroscopy,Drug Discovery,Radiology Nuclear Medicine and imaging,Biochemistry,Analytical Chemistry

Reference17 articles.

1. U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) PET Drugs - Current Good Manufacturing Practice (CGMP) 2009

2. U.S. Department of Health and Human Services Food and Drug Administration, FDA Guidance for Industry Q7A Good Manufacturing Practice for Active Pharmaceutical Ingredients (APIs) 2001

3. European Commission: Volume 4 of “The rules governing medicinal products in the European Union” Part II-Basic Requirements for Active Substances used as Starting Materials 2014

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