Chemistry for Toxicological Risk Assessment —Transitions in Expected Approach

One of the cornerstones of biocompatibility evaluations is the use of toxicological risk assessment to screen for potential hazards and safeguard against long-onset risks like cancer. While there is an abundance of toxicological literature available, and the techniques of toxicological risk assessment are generally accepted, the process for conducting the underlying chemistry studies is less mature. FDA has been building finesse in reviewing chemistry studies, helping the testing facilities to be more aware of the nuances in chemistry. New internal awareness and recent reports with poorly conducted studies used for regulatory submissions have raised anxiety regarding the extent of use of chemistry for toxicology (“ChemTox”) within the agency over the last year and motivated changes in expectations. A key change in ChemTox is the amount and type of information expected for submission. Regulators are asking for details regarding the methods used in identification of compounds and providing suggestions on when a compound should be considered an unknown. Part of this scrutiny is arising due to recent publications that focus on the shortcomings of external databases and automatic compound matching algorithms. Another focus is on detailed information regarding the type and quality of concentration quantification. FDA has been asking for details regarding the number and type of internal standards used and how this extrapola...
Source: MDDI - Category: Medical Devices Authors: Tags: Testing Source Type: news