Welcome. If you're a registered user, please log-in. If not, please sign-up.
  • registration@pti-europe.co.uk
  • phone:+44 (0) 20 7017 7481
  • GO

Analysing Biological Assays

Course Objectives

This 2-day course will cover basic computational processes necessary for analysis of the data from immunoassays and bioassays. Important considerations will be examined such as determining optimal assay conditions, choosing the appropriate nonlinear or linear regression fit, calculating correct residual weights, computing practical limits of sensitivity and acceptable error, measuring nonparallelism and potency, and compensating for matrix effects. These and other computational decisions will be discussed and examples will be presented showing different considerations.

 

The course will also outline a comprehensive and stepwise method for inspecting immunoassays and bioassays for problems and troubleshooting failed assays. This method is based upon a statistical comparison to a set of validated, well characterised historical assays performed and validated by the laboratory. This process allows the analyst to set realistic acceptance criteria that will only flag assays with failed components, identify the failed reagent or incubation condition, gauge the impact of that failed component on the results, and indicate a course of action. Attendees will then troubleshoot the failed component from examples selected from thousands of problem assays.

 

What Will You Learn?

  • Learn how to differentiate and handle edge effects, hook effects and other dose effects
  • Utilise the data obtained from preliminary assays, choose the optimal doses, determine realistic confidence limits and minimum and maximum doses, measure expected variation from assay to assay for final validation and approval
  • Understand the impact of different nonlinear and linear regression models particularly the 5 parameter, 4 parameter and 3 parameter logistic, on a variety of results
  • Understand potency testing and how to measure nonparallelism
  • Learn how to avoid dilutional nonlinearity by compensating for different matrix effects
  • Set justifiable guidelines for identifying and masking outliers
  • Develop criteria for evaluating assays so that good assays are not needlessly repeated and failed reagents or incubation conditions are correctly identified in bad assays
  • Receive a comprehensive course book with many examples that will serve as a future reference

Dates and Venues

17 May 2010 - 18 May 2010

Regus Trafalgar Square, London, UK

20 Sep 2010 - 21 Sep 2010

Regus St James's Park, London, UK

06 Dec 2010 - 07 Dec 2010

Regus Trafalgar Square, London, UK

Related Events

Comparability for Biologics

17 Aug 2010 - 18 Aug 2010
Regus Trafalgar Square, London, UK


EU Biosimilar Registration and Marketing Requirements

08 Sep 2010 - 09 Sep 2010
Regus Poultry, London, UK


Who Should Attend

This course is designed for all individuals who develop, validate, perform or monitor bioassays or immunoassays. Individuals who develop assay methodologies, assign computational and analysis criteria, measure and validate performance characteristics, perform, evaluate and troubleshoot problem assays, or are responsible for the quality of the data will benefit from the lessons and examples presented. No mathematical or statistical background is required, but attendees should have a basic understanding of bioassays or immunoassays.

LinkedIN

Connect with the PTI faculty! PTI is a global pharmaceutical training company with over 60 interctive courses focusing on Regulatory Affairs, R&D, Clinical, Business Strategy, Fine Chemicals, Biopharmaceuticals, Manufacturing, Medical Devices and Agrochemicals 

Download Latest Information Now

(updated 27 July 2010)


Bookmark and Share