The following guideline can be ordered through the address listed in the "Source/Publisher"-category. In cases in which you can order through the Internet we have established a hyperlink.

Stability Testing of Drug Substances and Drug Products


Freedom of Information Staff, (HFI 35), Food and Drug Administration, Rm. 12 A - 30, 5600 Fishers Lane, Rockville, MD 20857, USA,

Document Type:
FDA guidance for industry
114-page document issued by FDA on the topic of stability testing, both for conventional and for biotechnology products. Withdrawn in the meantime!

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