1.
US Food and Drug Administration Center for Drug Evaluation and Research. Nonclinical Safety Evaluation of Reformulated Drug Products and Products Intended for Administration by an Alternate Route: Guidance for Industry and Review Staff Good Review Practice.; 2015. https://www.fda.gov/files/drugs/published/Nonclinical-Safety-Evaluation-of-Reformulated-Drug-Products-and-Products-Intended-for-Administration-by-an-Alternate-Route.pdf.