Validation of Endotoxin Methods and Resolving Test Interference

Jun 20 2013

The bacterial endotoxins test (BET) is based on an enzymatic cascade that is highly sensitive but is susceptible to interference. This discussion will focus on the causes of BET interfering conditions and ways to resolve them. Acceptance criteria for validating BET methods include an interference screening procedure and successful recovery of an endotoxin positive control in at least three lots of drug product. FDA expectations for approval of BET methods in new drugs will be discussed during this webinar.

Presenter

• Dr. James Cooper, PharmD, FAPhA, Consultant