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Author: Drug Effectiveness Review Project
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Languages : en
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Author: Drug Effectiveness Review Project
Publisher:
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Languages : en
Pages :
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Author: Janet L. Stringer
Publisher: McGraw Hill Professional
ISBN: 0071769420
Category : Medical
Languages : en
Pages : 254
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Book Description
A time-saving, stress-reducing approach to learning the essential concepts of pharmacology Great for USMLE review! "This could be a very useful tool for students who struggle with understanding the most basic concepts in pharmacology for course and licensure examinations. 3 Stars."--Doody's Review Service Basic Concepts in Pharmacology provides you with a complete framework for studying -– and understanding -- the fundamental principles of drug actions. With this unique learning system, you’ll be able to identify must-know material, recognize your strengths and weaknesses, minimize memorization, streamline your study, and build your confidence. Basic Concepts in Pharmacology presents drugs by class, details exactly what you need to know about each class, and reinforces key concepts and definitions. With this innovative text you’ll be able to: Recognize the concepts you truly must know before moving on to other material Understand the fundamental principles of drug actions Organize and condense the drug information you must remember Review key information, which is presented in boxes, illustrations, and tables Identify the most important drugs in each drug class Seven sections specifically designed to simplify the learning process and help you gain an understanding of the most important concepts: General Principles Drugs That Affect the Autonomic Nervous System Drugs That Affect the Cardiovascular System Drugs That Act on the Central Nervous System Chemotherapeutic Agents Drugs That Affect the Endocrine System Miscellaneous Drugs (Includes Toxicology and Poisoning)
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Languages : en
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Languages : en
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Author: Tom Brody
Publisher: Academic Press
ISBN: 0128146486
Category : Medical
Languages : en
Pages : 671
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Book Description
FDA's Drug Review Process and the Package Label provides guidance to pharmaceutical companies for writing FDA-submissions, such as the NDA, BLA, Clinical Study Reports, and Investigator's Brochures. The book provides guidance to medical writers for drafting FDA-submissions in a way more likely to persuade FDA reviewers to grant approval of the drug. In detail, the book reproduces data on efficacy and safety from one hundred different FDA-submissions (NDAs, BLAs). The book reproduces comments and complaints from FDA reviewers regarding data that are fragmentary, ambiguous, or that detract from the drug's approvability, and the book reveals how sponsors overcame FDA's concerns and how sponsors succeeded in persuading FDA to grant approval of the drug. The book uses the most reliable and comprehensive source of information available for writing FDA-submissions, namely text and data from NDAs and BLAs, as published on FDA's website. The source material for writing this book included about 80,000 pages from FDA's Medical Reviews, FDA's Clinical Pharmacology Reviews, and FDA's Pharmacology Reviews, from one hundred different NDAs or BLAs for one hundred different drugs. Each chapter focuses on a different section of the package label, e.g., the Dosage and Administration section or the Drug Interactions section, and demonstrates how the sponsor's data supported that section of the package label. - Reveals strategies for winning FDA approval and for drafting the package label - Examples are from one hundred FDA-submissions (NDAs, BLAs) for one hundred different drugs, e.g., for oncology, metabolic diseases, autoimmune diseases, and neurological diseases - This book uses the most reliable and comprehensive source of information available for writing FDA-submissions, namely, the data from NDAs and BLAs as published on FDA's website at the time FDA grants approval to the drug
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Languages : en
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Author: Gerald Gartlehner
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Category : Biological response modifiers
Languages : en
Pages : 0
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Category :
Languages : en
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Author: Gerald Gartlehner
Publisher:
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Category : Outcome assessment (Medical care)
Languages : en
Pages : 0
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Author: Susan L. Norris
Publisher:
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Category : Diabetes
Languages : en
Pages :
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