1. Strategies for method comparison when changes in the immunogenicity method are needed within a clinical program
- Author
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Joleen T. White, Johanna R Mora, Qiang Qu, Linlin Luo, Amy Lavelle, Dennis Stocker, and Shannon D Chilewski
- Subjects
Data Pooling ,Computer science ,Immunogenicity ,Design of experiments ,010401 analytical chemistry ,Clinical Biochemistry ,Comparability ,Small sample ,General Medicine ,computer.software_genre ,030226 pharmacology & pharmacy ,01 natural sciences ,0104 chemical sciences ,Analytical Chemistry ,Pooling data ,03 medical and health sciences ,Medical Laboratory Technology ,0302 clinical medicine ,Method comparison ,Research Design ,Allergy and Immunology ,Humans ,Data mining ,General Pharmacology, Toxicology and Pharmaceutics ,computer - Abstract
Aim: To present the reader with different approaches used to compare immunogenicity methods when changes are needed during a clinical program. Results: Five case studies are presented, in the first two case studies, the approach utilized a small sample size for the comparison. In the third case, all samples from a study were analyzed by both methods. In the fourth case, the intended use of noncomparable assays in an integrated summary drove design of experiments to establish the expected limits of pooling data. In the fifth case, a selectivity approach was used as an alternate to use of incurred samples. Conclusion: When data pooling across methods is needed, it is important to define the limits of comparability.
- Published
- 2020
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