1. Erläuterungen des BGA zum Antrag auf Zulassung eines Arzneimittels (Febr. 1988).
2. The Rules Governing Medicinal Products in the European Community, volume 3 Addendum (1990).
3. CDER Guideline on Validation of Chromatographic Methods, Reviewer Guidance of Chromatographic Methods, U.S. Food and Drug Administration, Center for Drugs and Biologics, Department of Health and Human Services (1994).
4. Guidelines for Submitting Samples and Analytical Data for Methods Validation, U.S. Food and Drug Administration, Center for Drugs and Biologics, Department of Health and Human Services (1987).
5. United States Pharmacopeia, Section 〈1225〉 ‘Validation of Compendial Methods’, United States Pharmacopeial Convention, Rockville (1995).