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Anticancer drug development guide : preclinical screening, clinical trials, and approval
2004
2nd ed.
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Black box warnings and drug safety examining the determinants and timing of FDA warning labels
2006
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Clinical trials study design, endpoints and biomarkers, drug safety, and FDA and ICH guidelines
by
Brody, Tom
2016
Second edition
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Multiple Online Resources Available
Clinical trials study design, endpoints and biomarkers, drug safety, FDA and ICH guidelines
by
Brody, Tom
2012
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FDA's drug review process and the package label strategies for writing successful FDA submissions
by
Brody, Tom
2018
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Building a national framework for the establishment of regulatory science for drug development workshop summary
2011
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Cardiovascular drug development protocol design and methodology
1999
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The CDER reference guide
1995
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CDER ... report to the nation
by
Center for Drug Evaluation and Research (U.S.)
1997
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Joyner - Fed Docs Stacks
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HE 20.4701: 2002
CDER ... report to the nation : improving public health through human drugs
by
Center for Drug Evaluation and Research (U.S.)
1997
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