Approved Drug Products with Therapeutic Equivalence Evaluations

Approved Drug Products with Therapeutic Equivalence Evaluations PDF 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of any product is that the product is the subject of an application with an effective approval that has not been withdrawn for safety or efficacy reasons.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.

Approved Drug Products with Therapeutic Equivalence Evaluations

Approved Drug Products with Therapeutic Equivalence Evaluations PDF Author: Barry Leonard
Publisher: DIANE Publishing
ISBN: 0788173243
Category :
Languages : en
Pages : 829

Get Book Here

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of any product is that the product is the subject of an application with an effective approval that has not been withdrawn for safety or efficacy reasons.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.

Lehne's Pharmacotherapeutics for Advanced Practice Nurses and Physician Assistants - E-Book

Lehne's Pharmacotherapeutics for Advanced Practice Nurses and Physician Assistants - E-Book PDF Author: Laura D. Rosenthal
Publisher: Elsevier Health Sciences
ISBN: 0323598129
Category : Medical
Languages : en
Pages : 946

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Book Description
**Selected for Doody's Core Titles® 2024 in Pharmacology** Lehne's Pharmacotherapeutics for Advanced Practice Nurses and Physician Assistants, 2nd Edition builds on the same foundation of clearly explained, up-to-date, and clinically current content as the trusted Lehne undergraduate text, while focusing on the information that advanced practice nurses and Physician Assistants specifically need for safe and effective prescribing. Three introductory chapters provide foundational content for new prescribers in the areas of prescriptive authority, rational drug selection, prescription writing, and promoting positive outcomes of drug therapy. Core drug chapters are focused on the drugs that prescribers will most commonly see in clinical practice. A sharp focus is also placed on pharmacotherapeutic decision-making, with Black Box Warnings and new bulleted Key Prescribing Considerations features. The second edition features completely new chapters on Genetic and Genomic Considerations, Muscarinic Antagonists and Immunomodulators, and updated content throughout. It's everything advanced practice nursing and Physician Assistant students need to be safe and effective prescribers! - Introductory chapters tailored to the specific needs of prescribers cover topics such as prescriptive authority, rational drug selection and prescription writing, and promoting positive outcomes of drug therapy. - Carefully focused pharmacotherapeutic content reflects the drugs most commonly seen and used by prescribers, with emphasis not on the first drug discovered or developed in each class but on the agents most often used today. Primary care drugs are addressed first in each chapter as appropriate, followed by acute care drugs. - UNIQUE! Prescriber-focused pedagogical aids further reinforce the most important information for prescribers. - Integrated coverage of Canadian trade names appears throughout the text and is highlighted with a familiar maple-leaf icon. - Integrated coverage of interprofessional collaboration addresses the growing global interest in interprofessional collaboration and incorporates opportunities for interprofessional collaborative practice throughout.

Handbook of Pharmaceutical Manufacturing Formulations, Third Edition

Handbook of Pharmaceutical Manufacturing Formulations, Third Edition PDF 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

Androgen Deprivation Therapy

Androgen Deprivation Therapy PDF Author: Richard J. Wassersug, PhD
Publisher: Springer Publishing Company
ISBN: 0826183956
Category : Health & Fitness
Languages : en
Pages : 247

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Book Description
Praise for Androgen Deprivation Therapy: "To my knowledge [this] is the only book written in plain language (no medical jargon) explaining what’s happening during ADT, and detailing how to limit and often solve most associated side effects. It should be read by every man undergoing ADT, as well as family members and also healthcare providers. They will find all the details they need to get the most from this treatment..." Prof. N. Mottet, MD, PhD, Urologist, Medical Oncologist, Head of the Prostate Cancer Guidelines panel of the European Association of Urology Androgen Deprivation Therapy is the only guide written exclusively about the side effects of hormone therapy. The authors have collaborated with the European Association of Urology to produce this specially revised new edition to serve men affected by ADT across the globe. This comprehensive workbook for prostate cancer patients and their loved ones is filled with practical advice from experts in the field. The book covers a wealth of strategies to help men cope with ADT and maintain a good quality of life while on this treatment. It is not only an informational manual, but a guide for both patients and partners about ways to make changes in their lives that can keep them healthy and positive when the patient is on ADT. New to this Edition: Updates on the physical side effects of ADT and management strategies Expanded information on exercise and nutrition for men diagnosed with prostate cancer Updates on the primary drugs used to treat prostate cancer and extensive drug tables with common brand names worldwide Revisions throughout based on critical feedback from international medical experts in the field of prostate cancer and related disciplines Exercises, activities, worksheets, and other tools to promote discussion and inspire behavioural changes that can reduce the burden of ADT Officially endorsed by the European Association of Urology

The APRN and PA’s Complete Guide to Prescribing Drug Therapy 2020

The APRN and PA’s Complete Guide to Prescribing Drug Therapy 2020 PDF 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

Approved Drug Products With Therapeutic Equivalance Evaluations - FDA Orange Book 26th Edition (2006)

Approved Drug Products With Therapeutic Equivalance Evaluations - FDA Orange Book 26th Edition (2006) PDF 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)

The PA’s Complete Guide to Prescribing Drug Therapy 2019

The PA’s Complete Guide to Prescribing Drug Therapy 2019 PDF 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

Approved Drug Products with Therapeutic Equivalence Evaluations

Approved Drug Products with Therapeutic Equivalence Evaluations PDF Author:
Publisher:
ISBN:
Category : Drugs
Languages : en
Pages : 1048

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Book Description


Litt's Drug Eruption Reference Manual Including Drug Interactions

Litt's Drug Eruption Reference Manual Including Drug Interactions PDF 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

Approved Drug Products with Therapeutic Equivalence Evaluations - FDA Orange Book 31st Edition (2011)

Approved Drug Products with Therapeutic Equivalence Evaluations - FDA Orange Book 31st Edition (2011) PDF 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)