Evaluation of correlation between bioanalytical methods

Author:

Gleason Carol R1,Ji Qin C1,Wickremsinhe Enaksha R2

Affiliation:

1. Bristol-Myers Squibb Company, Princeton, NJ 08543, USA

2. Eli Lilly & Company, Indianapolis, IN 46285, USA

Abstract

Bioanalytical methods evolve throughout clinical development timelines, resulting in the need for establishing equivalency or correlation between different methods to enable comparison of data across different studies. This is accomplished by the conduct of cross validations and correlative studies to compare and describe the relationship. The incurred sample reanalysis acceptance criterion seems to be adopted universally for cross validations and correlative studies; however, this does not identify any trends or biases between the two methods (datasets) being compared. Presented here are graphing approaches suitable for comparing two methods and describing equivalence or correlation. This article aims to generate awareness on graphing techniques that can be adopted during cross validations and correlative studies.

Publisher

Future Science Ltd

Subject

Medical Laboratory Technology,Clinical Biochemistry,General Pharmacology, Toxicology and Pharmaceutics,General Medicine,Analytical Chemistry

Reference21 articles.

1. European Medicines Agency. Guideline on Bioanalytical Method Validation (2011). http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2011/08/WC500109686.pdf

2. National Institute of Health Sciences. Guideline on Bioanalytical Method Validation in Pharmaceutical Development (2013). http://www.nihs.go.jp/drug/BMV/BMV_draft_130415_E.pdf

3. US FDA. Guidance for Industry: Bioanalytical Method Validation (2018). https://www.fda.gov/downloads/drugs/guidances/ucm070107.Pdf

4. Workshop Report and Follow-Up—AAPS Workshop on Current Topics in GLP Bioanalysis: Assay Reproducibility for Incurred Samples—Implications of Crystal City Recommendations

5. Implementing Dried Blood Spot Sampling for Clinical Pharmacokinetic Determinations: Considerations from the IQ Consortium Microsampling Working Group

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