The Dosage Form — US and EEC Requirements for Documenting its Stability for Clinical Trials and Marketing

Guideline for submitting documentation for the stability of human drugs and biologics. Washington, DC: Center for Drugs and Biologics, Food and Drug Administration, US Department of Health and Human Services; February 1987.

Stability tests on active substances and finished products, note for guidance concerning the application of Section F of Part I of the Annex to Directive 75/318/EEC. III/66/87-EN Rev. 4. Brussels; 1988.

USP Subcommittee on Containers and Materials. Room temperature and controlled room temperature — general notices definitions. Pharmacop Forum. 1988;14: 3895.

Grimm W Schepky GN . Stability testing in pharmacy — theory and practice. Der Pharmazeut Betrieb. 1980;28: 335–372.

Fusari SA Hostetler GL . Reference thermal exposure and performance of room temperature stability studies. Pharmaceut Technol. 1984;8: 48.

Guideline for the format and content of an application summary. Washington, DC: Center for Drugs and Biologies, Food and Drug Administration, US Department of Health and Human Services; June 1985.

Guidance notes for application for product licenses (MAL 2). EEC Guidelines (Directive 75/318/EEC). London: Her Majesty's Stationer; 1987.