Guideline on the Preparation of Investigational New Drug Products (Human andAnimal)

摘要

The Food and Drug Administration guideline informs interested persons on certainpractices and procedures for the preparation of investigational new drug products for human and animal use that may be useful to persons seeking to comply with certain sections of the Current Good Manufacturing Practice (CGMP) Regulations for Finished Pharmaceuticals (Title 21 of the Code of Federal Regulations, Parts 210 and 211).