Xem 1-7 trên 7 kết quả Approved drug products
  • The publication Approved Drug Products with Therapeutic Equivalence Evaluations (the List, commonly known as the Orange Book) identifies drug products approved on the basis of safety and effectiveness by the Food and Drug Administration (FDA) under the Federal Food, Drug, and Cosmetic Act (the Act). (For more information, see the Orange Book Preface.)

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  • Description: Identifies drug products approved on the basis of safety and effectiveness by the Food and Drug Administration under the Federal Food, Drug, and Cosmetic Act.

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  • Safe and effective medical countermeasures, including vaccines, drugs, and diagnostics, are critical for responding to large-scale public health emergencies. Such situations, be they natural (e.g., pandemic influenza) or man-made (e.g., terrorism), have the potential to rapidly overwhelm public health and medical systems. America’s national security depends on having appropriately licensed chemical, biological, radiological, and nuclear medical countermeasures in its arsenal of defenses.

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  • Glofish is the first transgenic animal approved to be consumed by human in the USA  The insertion of different constructs of GFP into the fish genomes to give different green colors.The idea for recombinant DNA was first proposed by Peter Lobban, a graduate student of Prof. Dale Kaiser in the Biochemistry Department at Stanford University Medical School. The first publications describing the successful production and intracellular replication of recombinant DNA appeared in 1972 and 1973.

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  • On the federal level, three agencies regulate ART. The Centers for Disease Control and Prevention (CDC) collects and publishes data on ART procedures. The Food and Drug Administration (FDA) controls approval and use of drugs, biological products, and medical devices and has jurisdiction over screening and testing of reproductive tissues, such as donor eggs and sperm. The Centers for Medicare and Medicaid Services (CMS) is responsible for implementation of the Clinical Laboratory Improvement Act to ensure the quality of laboratory testing....

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  • 2’,3’-Dideoxynucleosides (ddNs) are the most important class of compounds active against HIV/AIDS. They act as DNA chain terminators and competitive inhibitors of viral reverse transcriptase (RT). Currently, stavudine (d4T, Zerit) is one six drugs belonging to the ddNs family that are approved by the FDA. This article describes the synthesis of generic stavudine drug from thymidine in three steps. By mean of this synthesis, stavudine was obtained in a good yield. The structure of product and intermediate were established by NMR spectroscopies.

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  • Registration or market approval of a drug by a country’s drug regulatory agency grants permission for a product from a specific manufacturer to be marketed in that country for the medical indications for which the application is made. The drug is then added to the country’s list of registered medicines. Since oxytocin and magnesium sulfate are included in national policies for maternal health in most countries, it is expected that these medicines would be registered in most countries.

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