The debate on animal ADME studies in drug development: an update (Q38265373)

1 September 2017

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title

The debate on animal ADME studies in drug development: an update (English)

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1 September 2017

Mario Pellegatti

1

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PubMed ID

25373428

1 September 2017

language of work or name

English

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publication date

6 November 2014

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Expert Opinion on Drug Metabolism & Toxicology

1 September 2017

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1 September 2017

10

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1 September 2017

12

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1 September 2017

1615-1620

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Toxicologic pathology in the 21st century

1 September 2017

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https://api.crossref.org/works/10.1517%2F17425255.2015.979152

Evaluation of preparative high performance liquid chromatography and cryoprobe-nuclear magnetic resonance spectroscopy for the early quantitative estimation of drug metabolites in human plasma.

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A simple liquid chromatography-tandem mass spectrometry method to determine relative plasma exposures of drug metabolites across species for metabolite safety assessments

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Obtaining exposures of metabolites in preclinical species through plasma pooling and quantitative NMR: addressing metabolites in safety testing (MIST) guidance without using radiolabeled compounds and chemically synthesized metabolite standards.

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Meeting report: metabolites in safety testing (MIST) symposium-safety assessment of human metabolites: what's REALLY necessary to ascertain exposure coverage in safety tests?

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Introduction: use of radioactive compounds in drug discovery and development

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The early estimation of circulating drug metabolites in humans

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

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

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Preclinical in vivo ADME studies in drug development: a critical review

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Radiolabeled absorption, distribution, metabolism, and excretion studies in drug development: why, when, and how?

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Pragmatic approaches to determine the exposures of drug metabolites in preclinical and clinical subjects in the MIST evaluation of the clinical development phase

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Practical experience of using human microdosing with AMS analysis to obtain early human drug metabolism and PK data

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Absorption, distribution, metabolism, and excretion (ADME) of ¹⁴C-sonidegib (LDE225) in healthy volunteers

21 January 2018

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Meeting the MIST regulations: human metabolism in Phase I using AMS and a tiered bioanalytical approach.

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Directly coupled high-performance liquid chromatography-accelerator mass spectrometry measurement of chemically modified protein and peptides

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10.1517/17425255.2015.979152

21 January 2018

Identifiers

DOI

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1 September 2017

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PubMed ID

25373428