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A Practical Approach to Effective Design of Experiments (DOE) in Pharma Development

Held in conjunction with Novel Formulation Strategies

19 Apr 2017, at 9:00 AM - 5:00 PM in Hyderabad


Course Background and Objectives

Design of experiments helps in determining empirical models of your processes in the fewest experiments possible – minimum time, minimum cost, MAXIMIUM information. The design-of-experiments (DOE) is NOT just a statistical technique, it is a thought process that allows extremely complex problems to be addressed in an effective manner. The objective of this course is to provide efficient strategies in using experimental design in product development without the need to become a highly skilled statistician. And how to apply QbD in Pharmaceutical Development for ANDA.

Who Should Attend?

This course provides practical advice and strategies for performing multivariate experimental design in pharmaceutical development that is now required in Drug Submissions to the Regulatory Agencies.  This course is useful for managers and scientists working in pharmaceutical industries and academia.

Course Outline 

This course will be divided in four sections:

1. Introduction to Multivariate Experimental Design (MED) using Design of Experiments (DOE)

  • What does MED bring to the scientist and engineer in accelerating drug development?
  • Real world examples of MED
  • When and when not to use DOE
  • Basic strategies in DOE
  • Introduction to DOE designs.

2. Design Process for Effective Experimentation

  • The Design cycle
  • Using DOE in multivariable experimental design format.

3. Practical Applications of Experimental Design for Accelerating Product Development

  • Case studies in formulation using high throughput technologies 
  • Case study in assay validation

4. Practical aspects of QbD in Pharmaceutical Product Development

  • Concepts of QbD based ANDA
  • Understanding Process and Product by identifying Critical Process Parameters (CPP) and Critical Quality Attributes (CQA) using DOE.
  • Examples from ANDAs submitted to FDA.

Rajiv Nayar

Rajiv Nayar, CEO, HTD Biosystems Inc.