Desorption/Ionization-MS Methods for Drug Quantification in Biological Matrices and Their Validation Following Regulatory Guidance-Reference-Cited by-同舟云学术

Desorption/Ionization-MS Methods for Drug Quantification in Biological Matrices and Their Validation Following Regulatory Guidance

Published:2021-04-29 Issue:19 Volume:93 Page:7152-7163
ISSN:0003-2700
Container-title:Analytical Chemistry
language:en
Short-container-title:Anal. Chem.

Author:

Fresnais Margaux¹,Burhenne Jürgen¹^ORCID,Haefeli Walter E.¹,Longuespée Rémi¹^ORCID

Affiliation:

1. Department of Clinical Pharmacology and Pharmacoepidemiology, Heidelberg University Hospital, Im Neuenheimer Feld 410, 69120 Heidelberg, Germany

Funder

Deutsche Forschungsgemeinschaft

Dietmar Hopp Stiftung

Publisher

American Chemical Society (ACS)

Subject

Analytical Chemistry

Link

https://pubs.acs.org/doi/pdf/10.1021/acs.analchem.1c00647

Reference33 articles.

1. Rapid MALDI-MS Assays for Drug Quantification in Biological Matrices: Lessons Learned, New Developments, and Future Perspectives

2. Advanced MALDI mass spectrometry imaging in pharmaceutical research and drug development

3. FDA. Bioanalytical method validation guidance for industry. US Food and Drug Administration, 2018. https://www.fda.gov/downloads/drugs/guidances/ucm070107.pdf (accessed 2021-04-07).

4. EMA. Guidelines on bioanalytical method validation. European Medicines Agency, 2011. https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-bioanalytical-method-validation_en.pdf (accessed 2021-04-07).

5. Rapid and Sensitive Quantification of Osimertinib in Human Plasma Using a Fully Validated MALDI–IM–MS/MS Assay

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