Isranalytica2017-baner

Dr. Orna Dreazen

Method validation, can the theory work in reality? - Pharmaceutical industry experience

Method validation is defined as: "Validation is the confirmation, by examination and the provision of objective evidence, that the particular requirements for a specific intended use are fulfilled. There is a consensus on the parameters that may be examined during the validation however there is no consensus on how it should be done.
The validation design is usually affected by practical considerations such as samples availability, their cost, duration of the study etc.
Validation study very often may indicate that the method is suboptimal in different characteristics. I.e. too high imprecision, inaccuracy, non-robust method etc..
A few cases will be discussed in the presentation to show what should be done when such results are shown and how should the industry react in such cases.