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In the pharmaceutical industry, drug dissolution testing is routinely used to provide critical in vitro drug release information for both quality control purposes, i.e., to assess batch-to-batch consistency of solid oral dosage forms such as tablets, and drug development, i.e., to predict in vivo drug release profiles. [1]
One exception occurred during the 2010 Swine Flu Epidemic when the FDA authorized expired Tamiflu based on SLEP Data. [9]The US FDA is able to extend the shelf life of drugs throughout national, state, local, tribal, and territorial stockpiles through two legal means: by issuing an Emergency Use Authorization on using a drug past its expiration date (which is legally an unapproved use of a ...
Approved Drug Products with Therapeutic Equivalence Evaluations, commonly known as the Orange Book, is a publication produced by the United States Food and Drug Administration (FDA), as required by the Drug Price and Competition Act (Hatch-Waxman Act).
FDA Building 51 is one of the main buildings in its White Oak campus that houses the Center for Drug Evaluation and Research. The Center for Drug Evaluation and Research (CDER, pronounced "see'-der") is a division of the U.S. Food and Drug Administration (FDA) that monitors most drugs as defined in the Food, Drug, and Cosmetic Act.
How To Find Out If Your State Is Affected By The FDA’s Massive Soda Recall. Allison Arnold. December 13, 2023 at 4:02 PM. Three Coca-Cola Brand Sodas Have Been Recalled NurPhoto - Getty Images.
Therapeutic Targets Database Zhejiang University: drugs and targets SMILES InChI CAS PubChem "TTD". 37,316 T3DB Toxin and Toxin-Target Database Toxic Exposome Database. University of Alberta: toxins and toxin targets T3D "T3DB". 3,678 UniChem EMBL-EBI pointers to existing chemicals; indexes 41 databases [12] Structure; StdInChI; links to databases
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The FDA Adverse Event Reporting System (FAERS or AERS) is a computerized information database designed to support the U.S. Food and Drug Administration's (FDA) postmarketing safety surveillance program for all approved drug and therapeutic biologic products.