Guidance for industry [electronic resource] : submission of documentation in applications for parametric release of human and veterinary drug products terminally sterilized by moist heat processes.
Imprint
Silver, Spring, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research ; Rockville, MD : Center for Veterinary Medicine : Center for Biologics Evaluation and Research, [2008]