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A Guide to Assay Development
Drug and Market Development Publishing, March 2003, Pages: 300
This Guide thoroughly evaluates the capabilities, strengths, weaknesses, and expectations of leading assays and assay technologies.
Assay development is often time consuming and frustrating. But reliable, robust assays are key to every phase of pharmaceutical development. This Guide to Assay Development provides critical information to speed and simplify the development and optimization of most technologies. This Guide eliminates the tendency to 'reinvent the wheel' by providing valuable tips that incorporate the author's many years of hands-on experience in the field.
This Guide provides the information necessary to select and develop the appropriate assay for the task at hand, including:
- The most common and rapidly-growing assays in the drug discovery and drug development industries.
- Charts and tables cut through the sales hype and facilitate comparisons of different assay types.
- Tips and tricks learned over 15 years of professional experience and collaborative work in laboratory assays.
- The often neglected topics of biological sample matrix and high-volume data analysis.
- Step-by-step instructions and checklists for assay optimization, validation, automation, scale-up, and miniaturization.
- Emerging platforms, formats, and technologies for high-throughput screening (HTS) and ultra-high-throughout screening (UHTS).
- Detailed comparisons of technologies designed to help scientists determine the best format to meet their assay needs.
- Lists of instrument manufacturers and supply vendors-including original references and historical developments, with resources for finding detailed modern laboratory recipes.
The following professionals involved in drug discovery, screening, lead generation, and assay technology will greatly benefit from this Guide:
Directors, Lab Managers, Group Leaders, Senior Scientists, Principal Scientists, Project Managers, Heads of Research & Development, Quality Control Managers, and more
This Guide Will Answer the Following Questions:
- How does a scientist determine the best assay for a particular application?
- What questions must be asked and answered during assay development?
- What steps are involved in optimization and validation of an assay?
- How can a scientist determine that an assay is fully optimized, sufficiently validated, and ready for full-scale operation?
- How can controls be used to provide the earliest warning of assay problems?
- How does sample throughput and assay miniaturization really affect data quality and reagent consumption?
- Will migrating to a higher-density microplate format improve throughput?
- How do state-of-the-art assay instruments fail during normal operation, and what can be done to minimize failure and the impact of failure on operations?
- What universal considerations are critically important for every assay?
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