Radiolabeled metabolite and disposition studies in support of safety assessment-Reference-Cited by-同舟云学术

Radiolabeled metabolite and disposition studies in support of safety assessment

Published:2015-03 Issue:5 Volume:7 Page:507-511
ISSN:1757-6180
Container-title:Bioanalysis
language:en
Short-container-title:Bioanalysis

Author:

Beattie Ashley¹,Madden Stephen²,Lowrie Chris¹,MacPherson David³

Affiliation:

1. Department of Environmental Sciences, Charles River, Edinburgh, EH33 2NE, UK

2. Department of Metabolism & Pharmacokinetics, Preclinical Services, Charles River, Edinburgh, EH33 2NE, UK

3. Department of Chemistry, Charles River, Edinburgh, EH33 2NE, UK

Publisher

Future Science Ltd

Subject

Medical Laboratory Technology,Clinical Biochemistry,General Pharmacology, Toxicology and Pharmaceutics,General Medicine,Analytical Chemistry

Link

http://www.future-science.com/doi/pdf/10.4155/bio.15.18

Reference9 articles.

1. ICH M3 (R2) – Non-Clinical Safety Studies for the Conduct of Human Clinical Trials and Marketing Authorization for Pharmaceuticals. (2008) www.ema.europa.eu/docs

2. The debate on animal ADME studies in drug development: an update

3. Radiolabelled mass-balance excretion and metabolism studies in laboratory animals: are they still necessary?

4. Radiolabeled mass-balance excretion and metabolism studies in laboratory animals: a commentary on why they are still necessary

5. From definition to implementation: a cross-industry perspective of past, current and future MIST strategies

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