CBER: new approaches to biological product testing.
Biological products are complex molecules and their testing presents unique technical challenges. Furthermore, there are certain expectations for the validation of methods applied for regulatory purposes. A few recent CBER policy initiatives which have an impact on the use of animal tests for biological products will be discussed, followed by an exposé of the MAPREC test for polio virus neurovirulence as an example of alternative test development and the validation process. Finally, some general comments about the validation process will be made.
Donlon
J A
JA
Center for Biologics Evaluation and Research, U.S. Food and Drug Administration, Rockville, MD 20852-1448, USA.
D000818:Animals; D001688:Biological Products / Q000737:chemistry / Q000592:standards*; D006801:Humans; D017955:Poliovirus / Q000472:pathogenicity; D011054:Poliovirus Vaccine, Inactivated / Q000009:adverse effects / Q000592:standards; D011786:Quality Control; D015203:Reproducibility of Results; D014774:Virulence
D001688:Biological Products; D011054:Poliovirus Vaccine, Inactivated