FDA Guidance for Industry: Quality Attribute Considerations for Chewable Tablets

Titel:
FDA Guidance for Industry: Quality Attribute Considerations for Chewable Tablets
Herkunft/Verlag:

FDA, http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM507098.pdf

Inhalt:
This guidance provides manufacturers of chewable tablets for human use with the Center for Drug Evaluation and Research’s (CDER) current thinking on the critical quality attributes that should be assessed during the development of these drug products

Zurück

GMP Seminare nach Thema