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Description

This three-day bioassay course consists of a two-day lecture presentation and a one-day hands-on laboratory experience. It will focus on the essential factors to be considered in the design, development and validation of bioassays.<br>The course introduces related USP general chapters, terminology, bioassay life cycle, important statistical tools and best practices, followed by a detailed discussion on the topics of design and development, robustness, validation and post-validation, with examples of USP pharmacopeial bioassay. The course reflects statistical tools in USP General Chapters <111>, <1030>, <1032>, <1033> and <1034>.<br>The lab portion of the course introduces attendees to best practices and techniques for successful bioassay development and validation. (Classroom 24 hours)

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Certificate of Analysis (specimen)

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Product data sheet

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USP | United States Pharmacopeia

US Pharmacopeia Standards set a global benchmark, enabling efficient, reliable, and cost-effective development and quality control of pharmaceuticals.

Official USP Reference Standards are highly characterized physical specimens intended for quality control use when conducting assays and tests for medicines as described in the USP-NF. When you conduct tests and assays required by the USP-NF using the USP reference standards specified, the results can be considered conclusive.

As a USP-Authorized Distributor, we offer the following products and services:

  • USP Reference Standards
  • USP Pharmaceutical Analytical Impurities
  • USP Training and educational programs