Approved Drug Products with Therapeutic Equivalence Evaluations PDF Download
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Author: Barry Leonard
Publisher: DIANE Publishing
ISBN: 0788173243
Category :
Languages : en
Pages : 829
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Book Description
Identifies drug products approved on the basis of safety and effectiveness by the FDA under the Federal Food, Drug, and Cosmetic Act. Drugs on the market approved only on the basis of safety (covered by the ongoing Drug Efficacy Study Implementation review) or pre-1938 drugs are not included in this publication. The main criterion for the inclusion of any product is that the product is the subject of an application with an effective approval that has not been withdrawn for safety or efficacy reasons. Contains therapeutic equivalence evaluations for approved multisource prescription drug products.
Author: Barry Leonard
Publisher: DIANE Publishing
ISBN: 0788173243
Category :
Languages : en
Pages : 829
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Book Description
Identifies drug products approved on the basis of safety and effectiveness by the FDA under the Federal Food, Drug, and Cosmetic Act. Drugs on the market approved only on the basis of safety (covered by the ongoing Drug Efficacy Study Implementation review) or pre-1938 drugs are not included in this publication. The main criterion for the inclusion of any product is that the product is the subject of an application with an effective approval that has not been withdrawn for safety or efficacy reasons. Contains therapeutic equivalence evaluations for approved multisource prescription drug products.
Author: Sarfaraz K. Niazi
Publisher: CRC Press
ISBN: 1351592238
Category : Medical
Languages : en
Pages : 453
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Book Description
The Handbook of Pharmaceutical Manufacturing Formulations, Third Edition: Volume Six, Sterile Products is an authoritative and practical guide to the art and science of formulating drugs for commercial manufacturing. With thoroughly revised and expanded content, this sixth volume of a six-volume set, compiles data from FDA and EMA new drug applications, patents and patent applications, and other sources of generic and proprietary formulations including author’s own experience, to cover the broad spectrum of cGMP formulations and issues in using these formulations in a commercial setting. A must-have collection for pharmaceutical manufacturers, educational institutions, and regulatory authorities, this is an excellent platform for drug companies to benchmark their products and for generic companies to formulate drugs coming off patent. Features: Largest source of authoritative and practical formulations, cGMP compliance guidance and self-audit suggestions Differs from other publications on formulation science in that it focuses on readily scalable commercial formulations that can be adopted for cGMP manufacturing Tackles common difficulties in formulating drugs and presents details on stability testing, bioequivalence testing, and full compliance with drug product safety elements Written by a well-recognized authority on drug and dosage form development including biological drugs and alternative medicines
Author: Mari J. Wirfs, PhD, MN, APRN, ANP-BC, FNP-BC, CNE
Publisher: Springer Publishing Company
ISBN: 0826179347
Category : Medical
Languages : en
Pages : 778
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Book Description
Includes more than 30 new diagnoses and eBook with digital updates as needed! Updated to deliver the most current standards, this is a unique prescribing reference for APRN students and advanced health care providers in all practice settings who need guidance on prescribing drugs for patients with acute, episodic, and chronic health problems. Concise, easy to read, and updated throughout, the resource delivers pharmacotherapy regimens for more than 600 diagnoses—including over 30 that are new. The print format includes an eBook with digital updates to assure immediate access to essential information. Listed alphabetically by diagnosis, pharmacotherapy regimens include, for each diagnosis, drug choices listed by generic name, FDA pregnancy category, generic/over-the-counter availability, adult/pediatric dosing regimens, brand names, forms of dosage, and additives. Clinically useful information such as laboratory values to be monitored, patient teaching points, and safety information is interspersed throughout each diagnosis. Additional quick-access features include information presented in convenient table format and an alphabetical cross-reference index of drugs by generic and brand name, with FDA pregnancy category and controlled drug schedule (I, II, III, IV, V). Key Features: Includes 31 new diagnoses totaling over 600 organized alphabetically Serves as a quick-access prescribing reference for APRN and PA students and health care providers in all primary care settings Presents drug information in condensed and summary form for ease of use Within each diagnosis, drug choices are listed alphabetically by generic /trade name, FDA pregnancy category, adult/pediatric dosing, dose forms, and additives Delivers guidance on lab values to be monitored, patient education points, and safety information Includes 30 Appendices with ready access to key drug classifications, FDA Pregnancy Categories, US Schedule of Controlled Substances, Immunization Schedules, Contraceptive Guidance, categories Anti-Infectives, and more! Offers brand/generic cross-reference
Author: Food and Drug Administration
Publisher: DrugPatentWatch.com
ISBN: 1934899763
Category : Medical
Languages : en
Pages : 1023
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Book Description
FDA Orange Book 26th Edition - 2006 (Approved Drug Products With Therapeutic Equivalence Evaluations)
Author: Mari J. Wirfs, PhD, MN, APRN, ANP-BC, FNP-BC, CNE
Publisher: Springer Publishing Company
ISBN: 082615106X
Category : Medical
Languages : en
Pages : 857
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Book Description
A quick-access guide to current drug recommendations with regular digital updates! Organized for speedy retrieval of vital information, this prescribing reference is designed for PAs and other advanced healthcare providers in all clinical practice settings. Available in print with ebook and regular digital updates, it guides practitioners involved in the primary care management of patients with acute, episodic, and chronic health problems in selecting appropriate pharmacology options and treatment regimens for over 500 diagnoses. Concise and easy to use, it is the only such resource organized by diagnosis, delivering drug choices alphabetically by generic name, with FDA pregnancy category, generic/over-the-counter forms, adult/pediatric dosing regimens, brand names, available dose forms, and additives. A helpful feature is the Comments interspersed throughout, offering such clinically useful information as laboratory values to monitor, patient teaching points, and safety information. Thirty appendices present information in table format, and an alphabetical cross-referenced index of drugs by generic and brand names, with FDA pregnancy category and controlled drug schedule, facilitates quick identification of drugs by alternate names and safety during pregnancy. KEY FEATURES: Presents information in concise format for speedy drug information retrieval Organized by diagnosis in a consistent format that lists drug choices alphabetically by generic name, FDA pregnancy category, availability of generic and trade name, adult/pediatric dosing, dose forms, and more Highlights clinically important information such as lab values to be monitored, patient education points, and safety information Offers 30 tables providing ready access to key drug classifications, FDA pregnancy categories, Schedule of Controlled Substances, and many others Presents brand-generic cross reference Includes free ebook and regular updates with purchase
Author:
Publisher:
ISBN:
Category : Drugs
Languages : en
Pages : 1048
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Book Description
Author: Jerome Z. Litt
Publisher: CRC Press
ISBN: 184214250X
Category : Medical
Languages : en
Pages : 1986
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Book Description
The most widely acclaimed book for practicing dermatologists, now expanded and improved. A must for every dermatologist's office --and for hospital consultations--this updated and substantially enlarged edition answers the busy physician's need for a comprehensive, authoritative guide to the known adverse side effects of newly approved as well as commonly prescribed and over-the-counter drugs, herbals, and supplements. The easy-to-use format and wealth of information make this book and CD-ROM combination an essential resource for dermatologists and general practitioners. Important features in this edition: Extensive listing of over 1,000 adverse reactions More than 950 generic and over 5,400 trade name drugs, herbals, and supplements Identification of potentially hazardous drug-drug interactions Citations of more than 25,000 references, up to October 2003 Coverage of dermatologic and other side effects that can develop from the use of commonly prescribed medications, OTC drugs, herbals, and supplements Sixty-four color illustrations and descriptions of 101 common reaction patterns Fully cross-referenced by drug and trade names with names of pharmaceutical companies plus indications, category, and half-life for each drug The CD-ROM provides rapid access to all the drug profiles in the book
Author: Food and Drug Administration
Publisher: DrugPatentWatch.com
ISBN: 193489981X
Category : Medical
Languages : en
Pages : 1253
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Book Description
FDA Orange Book 31st Edition - 2011 (Approved Drug Products With Therapeutic Equivalence Evaluations)
Author: Simon Poole
Publisher: John Wiley & Sons
ISBN: 1119912598
Category : Medical
Languages : en
Pages : 455
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Book Description
The book that’s been helping people with diabetes live their best lives for 20 years Diabetes For Dummies is a trusted resource that guides those diagnosed with diabetes and pre-diabetes and their caregivers towards optimal health. This book helps you, or those you love, achieve the life you want while managing diabetes with lifestyle changes, alternative therapies and the latest medications. This fully updated edition helps you tackle your symptoms with the confidence that you’re doing the latest stuff and following the newest advances in diabetes treatment. Powerful lifestyle strategies, new medications, monitoring equipment, nutritional guidelines, delicious recipes, and insulin delivery methods—it’s all in this friendly Dummies guide. Understand the types of diabetes and learn about your diagnosis Learn the latest treatment options, medications, and evidence-based therapies Manage your symptoms and live a full life with expert diet and lifestyle tips Answer your questions with this trusted, compassionate guide, now in its 6th edition Take control and understand how to improve or even prevent and reverse prediabetes and diabetes This book is an indispensable resource for those newly diagnosed with diabetes, and prediabetes, their loved ones, and care givers, as well as health care professionals who need an up-to-date reference on the latest in diabetes research.
Author: Jeanne Held-Warmkessel
Publisher: Jones & Bartlett Learning
ISBN: 9780763740467
Category : Medical
Languages : en
Pages : 252
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Book Description
Designed for clinical nurses caring for prostate cancer patients at the bedside, in the hospital, outpatient clinic, or home, this easy-to-use reference provides nurses with practical material that is useful in the day-to-day care of patients with prostate cancer.
