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Regulatory Aspects of Chemistry Manufacturing and Controls for Investigational New Drug Applications and Biologic License Applications to the United States Food and Drug Administration
Comprehensive Biotechnology
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10.1016/b978-0-444-64046-8.00178-6
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2019
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pp. 473-486
Author(s):
K. Lee
Keyword(s):
United States
◽
Drug Administration
◽
Food And Drug Administration
◽
The United States
◽
Regulatory Aspects
◽
New Drug
◽
United States Food
◽
States Food
Download Full-text
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Regulatory Aspects of Chemistry Manufacturing and Controls for Investigational New Drug Applications and Biologic License Applications to the United States Food and Drug Administration
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10.1016/b978-0-08-088504-9.00452-9
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pp. 439-452
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Update on regulatory review intervals for ophthalmic new drug applications at the United States Food and Drug Administration
American Journal of Ophthalmology
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10.1016/s0002-9394(00)00579-1
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2000
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Vol 130
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Developing Drugs for Prevention of Chemotherapy-Induced Nausea and Vomiting: Draft Guidance from the United States Food and Drug Administration
Clinical Cancer Research
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10.1158/1078-0432.ccr-21-1941
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2021
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pp. clincanres.1941.2021
Author(s):
Erica Lyons
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Charles Line
◽
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Keyword(s):
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Effects of hypoxia and glutathione depletion on hemoglobin- and myoglobin-mediated oxidative stress toward endothelium1The opinions and assertions contained herein are the scientific views of the authors and are not to be construed as policy of the United States Food and Drug Administration or the United States Army.1
Biochimica et Biophysica Acta (BBA) - Molecular Cell Research
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10.1016/s0167-4889(99)00163-9
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2000
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Vol 1495
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pp. 150-159
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Cited By ~ 28
Author(s):
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The Regulation of Drug Products by the United States Food and Drug Administration
The Textbook of Pharmaceutical Medicine
◽
10.1002/9780470987391.ch20
◽
2007
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pp. 565-601
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The United States Food and Drug Administration and ICH Guidance for Industry Q7A Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients
GMP/ISO Quality Audit Manual for Healthcare Manufacturers and Their Suppliers, (Volume 2 - Regulations, Standards, and Guidelines)
◽
10.3109/9780203026656-8
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2004
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pp. 57-97
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The United States Food and Drug Administration
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10.1142/9789813278851_0008
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pp. 59-77
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Regulatory science: a special update from the United States Food and Drug Administration
Toxicology Letters
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10.1016/s0378-4274(99)00152-6
◽
2000
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Vol 111
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pp. 199-202
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Cited By ~ 19
Author(s):
Kuei-Meng Wu
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Prognostic Implication of the United States Food and Drug Administration-defined BCG-unresponsive Disease
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10.1016/j.eururo.2018.09.028
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2019
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pp. 8-10
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...
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Nonclinical Development of Radiopharmaceuticals: Regulatory Considerations for the United States Food and Drug Administration
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10.1007/978-3-662-07310-0_8
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2004
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pp. 151-165
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