Related Experiment Videos
Repeat analysis and incurred sample reanalysis: recommendation for best practices and harmonization from the global
Eric Fluhler1, Faye Vazvaei, Puran Singhal
1Pfizer, PDM-NBE, Pearl River, New York, USA, eric.fluhler@pfizer.com.
The AAPS Journal
|August 20, 2014
Summary
The A7 harmonization team (A7 HT) reviewed best practices for repeat analysis and incurred sample reanalysis (ISR) in regulated bioanalysis. Their recommendations aim to harmonize global bioanalytical practices.
Area of Science:
- Pharmacokinetics and Drug Metabolism
- Analytical Chemistry
- Regulatory Science
Background:
- Regulated bioanalysis requires robust methods for data integrity.
- Repeat analysis and incurred sample reanalysis (ISR) are critical quality control steps.
- International harmonization of these practices is needed.
Purpose of the Study:
- To review and define best practices for repeat analysis and ISR in regulated bioanalysis.
- To develop consensus-based recommendations for global application.
- To identify areas lacking consensus for further discussion.
Main Methods:
- International team (A7 HT) collated common practices and guidance.
- Assessed scientific and logistical suitability of existing methods.
- Developed and refined best practice recommendations through expert discussions and scientific meetings.
Main Results:
- Summarized findings and proposed best practice recommendations for repeat analysis and ISR.
- Highlighted specific areas where consensus was not reached.
- Established a foundation for international harmonization.
Conclusions:
- The A7 HT recommendations contribute to the Global Bioanalysis Consortium's (GBC) harmonization efforts.
- These recommendations will guide future international standards in regulated bioanalysis.
- Further discussion is needed on topics without full consensus.