Internal standard variability: root cause investigation, parallelism for evaluating trackability and practical considerations-Reference-Cited by-同舟云学术

Internal standard variability: root cause investigation, parallelism for evaluating trackability and practical considerations

Published:2024-05-09 Issue: Volume: Page:1-6
ISSN:1757-6180
Container-title:Bioanalysis
language:en
Short-container-title:Bioanalysis

Author:

Zhang Jinhui¹,Dasgupta Arindam²,Ayala Ruben²,Bonapace Charles²,Kassim Sean³,Faustino Patrick J¹

Affiliation:

1. Division of Product Quality Research, Office of Testing & Research, Office of Pharmaceutical Quality, Food & Drug Administration, Center for Drug Evaluation & Research, 10903 New Hampshire Avenue, Silver Spring, MD 20993, USA

2. Division of New Drug Study Integrity, Office of Study Integrity & Surveillance, Office of Translational Sciences, Food & Drug Administration, Center for Drug Evaluation & Research, 10903 New Hampshire Avenue, Silver Spring, MD 20993, USA

3. Office of Study Integrity & Surveillance, Office of Translational Sciences, Food & Drug Administration, Center for Drug Evaluation & Research, 10903 New Hampshire Avenue, Silver Spring, MD 20993, USA

Publisher

Informa UK Limited

Link

https://www.tandfonline.com/doi/pdf/10.1080/17576180.2024.2348939

Reference25 articles.

1. FDA. M10 bioanalytical method validation and study sample analysis. 2022. https://www.fda.gov/media/162903/download

2. FDA/CDER. Evaluation of internal standard responses during chromatographic bioanalysis: questions and answers guidance for industry. 2019. https://www.fda.gov/media/130451/download

3. Evaluation, identification and impact assessment of abnormal internal standard response variability in regulated LC−MS bioanalysis

4. Internal standard response variations during incurred sample analysis by LC–MS/MS: Case by case trouble-shooting

5. Systematic internal standard variability and issue resolution: two case studies

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