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Clinical Research and Regulatory Affairs Volume 14, 1997 - Issue 2

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Original Article

Acceptance Limits for Bioequivalence Studies

C. T. Rhodes Department of Applied Pharmaceutical Sciences, University of Rhode, Kingston, RI, Island, 02881

Pages 127-137 | Published online: 02 Jul 2009

Cite this article
https://doi.org/10.3109/10601339709019634

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Rhodes C. T. Clinical Research and Drug Regulatory Affairs 1994; 11: 181–184
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Benet L., Goyan J. Pharmacotherapy 1995; 15: 433–440
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Rhodes C. T. Clinical Research and Drug Regulatory Affairs 1995; 12: 267–272
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Rosenbaum S. E., Lam J. Drug Development and Industrial Pharmacy 1997; 22: 337–344
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CFR. 320–33
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James Benson S. Acting Commissioner of Food and Drugs. 1 October, 1990, Letter from
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FDA Compliance Program Guide Manual. 15 August, 1994, published
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SUPAC Guidelines. November, 1995, published
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Rhodes C. T. Chapter on Bioequivalence. Drugs for Clinical Trials, Monkhouse, Rhodes. Marcel Dekker. 1997
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Rosenbaum S. E.A., Carter A., Dudley M. N. Drug Development and Industrial Pharmacy 1995; 9: 1115–1139
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