7. U.S. Food and Drug Administration; on Medical Device Patient Labeling; Final Guidance “Guidance for Industry and FDA Reviewers,” April 19, 2001. 8. Lin, S.C.; size for therapeutic equivalence based on confidence interval,” Drug Information “Sample Vol. 1995; 29, 45-50. Journal
7. U.S. Food and Drug Administration; “Guidance on Medical Device Patient Labeling; Final Guidance for Industry and FDA Reviewers,” April 19, 2001. 8. Lin, S.C.; “Sample size for therapeutic equivalence based on confidence interval,” Drug Information Journal Vol. 1995; 29, 45-50.
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