Meeting report of the 3rd European Biotransformation Workshop-Reference-Cited by-同舟云学术

Meeting report of the 3rd European Biotransformation Workshop

Published:2023-01-31 Issue:2 Volume:53 Page:123-127
ISSN:0049-8254
Container-title:Xenobiotica
language:en
Short-container-title:Xenobiotica

Author:

Walles Markus¹,Pähler Axel²,Isin Emre M.³,Ahlqvist Marie M.⁴

Affiliation:

1. Department of Pharmacokinetic Sciences, Novartis Institutes for Biomedical Research, Basel, Switzerland

2. F Hoffmann-La Roche AG Research and Development Division, Pharma Research and Early Development, Basel, Switzerland

3. Les Laboratoires Servier SAS Recherche and Developpement, DMPK, Translational Medicine, Servier, France

4. Drug Metabolism and Pharmacokinetics, Research and Early Development, Cardiovascular, Renal and Metabolism, BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden

Publisher

Informa UK Limited

Subject

Health, Toxicology and Mutagenesis,Pharmacology,Toxicology,Biochemistry,General Medicine

Link

https://www.tandfonline.com/doi/pdf/10.1080/00498254.2023.2173105

Reference9 articles.

1. Absorption, Distribution, Metabolism, and Excretion of Therapeutic Proteins: Current Industry Practices and Future Perspectives

2. EMA 2008. ICH Topic M 3 (R2). Note for the guidance on non-clinical safety studies for the conduct of human clinical trials and marketing authorisation for pharmaceuticals.

3. FDA. 2020. Safety testing of drug metabolites: guidance for industry. Silver Spring (MD): FDA.

4. FDA. 2022. Clinical pharmacology considerations for human radiolabeled mass balance studies. Draft guidance. Silver Spring (MD): FDA.

5. On the separation of enantiomers by drift tube ion mobility spectrometry

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