CENTER FOR DRUG EVALUATION AND RESEARCH APPLICATION NUMBER: 21-306 PHARMACOLOGY REVIEW(S) 1 REVIEW AND EVALUATION OF PHARMACOLOGY AND TOXICOLOGY DATA Division of Anesthetic, Critical Care, and Addiction Drug Products (HFD-170) Supplemental Review
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Workgroup Report: Review of Genomics Data Based on Experience with Mock Submissions—View of the CDER Pharmacology Toxicology Nonclinical Pharmacogenomics Subcommittee
Over the past few years, both the U.S. Food and Drug Administration (FDA) and the pharmaceutical industry have recognized the potential importance of pharmacogenomics and toxicogenomics to drug development. To resolve the uncertainties surrounding the use of microarray technology and the presentation of genomics data for regulatory purposes, several pharmaceutical companies and genomics technol...
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Punica granatum (Pg), commonly known as pomegranate (Pg), is a member of the monogeneric family, Punicaceae, and is mainly found in Iran which is considered to be its primary centre of origin. Pg and its chemical components possess various pharmacological and toxicological properties including antioxidant, anti-inflammatory (by inhibiting pro-inflammatory cytokines), anti-cancer and anti-angiog...
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Punica granatum (Pg), commonly known as pomegranate (Pg), is a member of the monogeneric family, Punicaceae, and is mainly found in Iran which is considered to be its primary centre of origin. Pg and its chemical components possess various pharmacological and toxicological properties including antioxidant, anti-inflammatory (by inhibiting pro-inflammatory cytokines), anti-cancer and anti-angiog...
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