.FDA发布咀嚼片关键质量属性指导原则（中英文对照）I. INTRODUCTIONI.引言This guidance provides manufacturers of chewable tablets for human use with the Center for Drug Evaluation and Researchs (CDER) current thinking on the critical quality attributes that should be assessed during the development of these drug products.2 This guidance also provides recommendations about submitting developmental, manufacturing, and labeling information for chewable tablets that must be approved by CDER before they can be distri
