Incurred sample reanalysis in bioequivalence studies for abbreviated new drug applications-Reference-Cited by-同舟云学术

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Incurred sample reanalysis in bioequivalence studies for abbreviated new drug applications

Published:2014-12 Issue:24 Volume:6 Page:3349-3354
ISSN:1757-6180
Container-title:Bioanalysis
language:en
Short-container-title:Bioanalysis

Author:

Subramaniam Sriram¹,Stier Ethan¹,Davit Barbara M²

Affiliation:

1. Division of Bioequivalence II, Office of Generic Drugs, Food & Drug Administration, 10903 New Hampshire Avenue, Silver Spring, MD 20993, USA

2. Merck Sharp & Dohme Corp, Whitehouse Station, NJ, USA - The work was conducted while the author was with the FDA.

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.14.232

Reference14 articles.

1. Workshop/conference report—Quantitative bioanalytical methods validation and implementation: Best practices for chromatographic and ligand binding assays

2. Incurred sample reanalysis (ISR): a decisive tool in bioanalytical research

3. Investigation and resolution of incurred sample reanalysis failures: two case studies

4. Identifying trends and developing solutions for incurred sample reanalysis failure investigations in a bioanalytical CRO

5. Impact of Differential Recovery in Bioanalysis: The Example of Bortezomib in Whole Blood

Cited by 4 articles. 订阅此论文施引文献订阅此论文施引文献，注册后可以免费订阅5篇论文的施引文献，订阅后可以查看论文全部施引文献

1. Considerations and perspectives on the practice of incurred sample reanalysis assessment for chiral drugs;Biomedical Chromatography;2024-07-04

2. The Prevalence of Several Treatments in Preventing the Back Conversion of Acyl Glucuronide Metabolites in Abbreviated New Drug Applications;The AAPS Journal;2023-03-01

3. A decade of incurred sample reanalysis: failures, investigations and impact;Bioanalysis;2018-11-01

4. Incurred sample reanalysis: adjusted procedure for sample size calculation;Bioanalysis;2017-11

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