Bioanalytical Methods Validation for Human Studies - Pharmanet
Bioanalytical Methods Validation for Human Studies - Pharmanet
Bioanalytical Methods Validation for Human Studies - Pharmanet
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Guidance <strong>for</strong> Industry<br />
<strong>Bioanalytical</strong> <strong>Methods</strong> <strong>Validation</strong><br />
<strong>for</strong> <strong>Human</strong> <strong>Studies</strong><br />
Additional copies are available from:<br />
Drug In<strong>for</strong>mation Branch (HFD-210)<br />
Center <strong>for</strong> Drug Evaluation and Research (CDER)<br />
5600 Fishers Lane, Rockville, MD 20857 (Tel) 301-827-4573<br />
Internet at http://www.fda.gov/cder/guidance/index.htm<br />
U.S. Department of Health and <strong>Human</strong> Services<br />
Food and Drug Administration<br />
Center <strong>for</strong> Drug Evaluation and Research (CDER)<br />
December 1998<br />
BP #<br />
j:\!guidance\2578dft.wpd<br />
12/14/98
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