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Oncology Drug Development World Europe 2008
Venue
The Hilton London Euston Hotel
Pre-conference workshop
14 October 10.30am - 4:00pm
Day 1
15 October 8.30am - 5:30pm
Day 2
16 October 8.30am - 5:30pm
London, United Kingdom
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Pre-conference Workshop - Tuesday 14 October 2008, The Hilton Euston Hotel
Biomarker assay development and validation
This practical and interactive tutorial will focus on the recommendations for the best practices in the development and validation of bio-marker assay development, method validation and sample analysis, with special emphasis on assays where a reference standard material is available.
Agenda:
- Introduction - Nomenclature, types of biomarker methods/assays, biomarker method development & validation road-map, fundamental validity, similarity to PK assays & difference from diagnostic application.
- Pre-analytical and Bioanalytical elements: Target range, standards, validation & QC samples, stability, matrix ef-fect, and relative selectivity.
- Calibration curve model selection, evaluation, and weighting.
- Method feasibility and optimization with precision profiles.
- Evaluation of some pre-study validation characteristics such as precision, bias, sensitivity and quantification limits.
- Illustrations of pre-study validation and in-study validation (sample analysis).
Your workshop leader:
 John Allinson, is a Fellow of the Institute of Biomedical Sciences (FIBMS) and, having spent 22 years in diagnostic laboratories in the National Health Service, has experience in all major fields of clinical pathology. He has managed and developed specialist laboratory services for drug monitoring, trace metals, and immunoassays. During a tenure in a large CRO, he developed analytical services for a large central clinical laboratory conducting all phases of pre-clinical and clinical trials. This work necessitated the validation of more than 100 immunoassays on a variety of analytical platforms.
Registration is from 9:30am. The workshop will begin at 10:30am and will end at 16:00. Lunch and refreshments will be provided.
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