EPCLUSA Drug Profile, 2023

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Author :
Publisher : DrugPatentWatch.com
ISBN 13 : 1934899577
Total Pages : 171 pages
Book Rating : 4.9/5 (348 download)

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Book Synopsis EPCLUSA Drug Profile, 2023 by : DrugPatentWatch

Download or read book EPCLUSA Drug Profile, 2023 written by DrugPatentWatch and published by DrugPatentWatch.com. This book was released on 2023-08-15 with total page 171 pages. Available in PDF, EPUB and Kindle. Book excerpt:

EPCLUSA Drug Profile, 2023

This report focuses on EPCLUSA and covers the following critical aspects of this drug:

  • United States patents
  • District Court patent litigation
  • Patent Trial and Appeal Board (PTAB) patent cases
  • European supplementary protection certificates (SPCs)
  • Clinical trials
  • Drug prices
  • Finished product suppliers

HARVONI Drug Profile, 2023

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Author :
Publisher : DrugPatentWatch.com
ISBN 13 : 1934899526
Total Pages : 215 pages
Book Rating : 4.9/5 (348 download)

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Book Synopsis HARVONI Drug Profile, 2023 by : DrugPatentWatch

Download or read book HARVONI Drug Profile, 2023 written by DrugPatentWatch and published by DrugPatentWatch.com. This book was released on 2023-08-15 with total page 215 pages. Available in PDF, EPUB and Kindle. Book excerpt:

HARVONI Drug Profile, 2023

This report focuses on HARVONI and covers the following critical aspects of this drug:

  • United States patents
  • District Court patent litigation
  • Patent Trial and Appeal Board (PTAB) patent cases
  • European supplementary protection certificates (SPCs)
  • Clinical trials
  • Drug prices
  • Annual sales revenues
  • Finished product suppliers

Fundamentals of HIV Medicine 2023

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Author :
Publisher : Oxford University Press
ISBN 13 : 0197679099
Total Pages : 577 pages
Book Rating : 4.1/5 (976 download)

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Book Synopsis Fundamentals of HIV Medicine 2023 by : The American Academy of Hiv Medicine

Download or read book Fundamentals of HIV Medicine 2023 written by The American Academy of Hiv Medicine and published by Oxford University Press. This book was released on 2023-10-24 with total page 577 pages. Available in PDF, EPUB and Kindle. Book excerpt: The essential textbook for HIV care providers and pharmacists--updated for 2023! Fundamentals of HIV Medicine has served as a key resource for clinicians preventing and treating HIV for over a decade. An end-to-end clinical resource for the treatment of individuals with HIV/AIDS, Fundamentals of HIV Medicine 2023 offers practitioners immediate, indexed access to the most recent science, research, and guidelines related to all aspects of HIV care and prevention. Now updated to reflect the convergent knowledge at the intersection of two global pandemics, HIV and COVID-19, Fundamentals of HIV Medicine 2023 offers state-of-the-art continuing education for physicians, pharmacists, nurse practitioners, physician assistants, nurses, and other professionals working in the care of HIV patients. This revised edition features key clinical updates across classic domains of HIV medicine along with new understandings of injectable antiretroviral treatment and explorations into concepts of HIV latency for long-term viral remission. Embodying the American Academy of HIV Medicine's commitment to excellence in the care of seropositive patients, Fundamentals of HIV Medicine 2023 is a must-have for health professionals across HIV care, treatment, and prevention.

Conn's Current Therapy 2023 - E-Book

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Author :
Publisher : Elsevier Health Sciences
ISBN 13 : 0443105626
Total Pages : 1637 pages
Book Rating : 4.4/5 (431 download)

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Book Synopsis Conn's Current Therapy 2023 - E-Book by : Rick D. Kellerman

Download or read book Conn's Current Therapy 2023 - E-Book written by Rick D. Kellerman and published by Elsevier Health Sciences. This book was released on 2022-11-02 with total page 1637 pages. Available in PDF, EPUB and Kindle. Book excerpt: Trusted by clinicians for more than 75 years, Conn’s Current Therapy presents today’s evidence-based information along with the personal experience and discernment of expert physicians. The 2023 edition is an excellent resource for a wide range of healthcare professionals, including primary care, subspecialists, and allied health, providing current treatment information in a concise yet in-depth format. Nearly 350 topics have been carefully reviewed and updated to bring you state-of-the-art content in even the most rapidly changing areas of medicine. Offers personal approaches from recognized leaders in the field, covering common complaints, acute diseases, and chronic illnesses along with the most current evidence-based clinical management options. Follows a consistent, easy-to-use format throughout, with diagnosis, therapy, drug protocols, and treatment pearls presented in quick-reference boxes and tables for point-of-care answers to common clinical questions. Includes new chapters on leg edema and venous stasis, multisystem inflammatory syndrome in children (MIS-C), monoclonal antibodies, and genetic testing. Incorporates more electronic links throughout the text that connect the reader to apps and clinical prediction tools that can easily be accessed in practice. Features thoroughly reviewed and updated information from many new authors and two new associate editors, Drs. Joel J. Heidelbaugh and Ernestine M. Lee, who offer a fresh perspective and their unique personal experience and judgment. Provides current drug information thoroughly reviewed by PharmDs. Features nearly 300 images, including algorithms, anatomical illustrations, and photographs, that provide useful information for diagnosis.

Ferri's Clinical Advisor 2023

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Author :
Publisher : Elsevier Health Sciences
ISBN 13 : 0323755747
Total Pages : 4950 pages
Book Rating : 4.3/5 (237 download)

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Book Synopsis Ferri's Clinical Advisor 2023 by : Fred F. Ferri

Download or read book Ferri's Clinical Advisor 2023 written by Fred F. Ferri and published by Elsevier Health Sciences. This book was released on 2022-06-21 with total page 4950 pages. Available in PDF, EPUB and Kindle. Book excerpt: For 25 years, Ferri’s Clinical Advisor has provided immediate answers on the myriad medical diseases and disorders you’re likely to encounter in a unique, easy-to-use format. A bestselling title year after year, this popular "5 books in 1" reference delivers vast amounts of information in a user-friendly manner. It is updated annually to provide current and clinically relevant answers on over 1,000 common medical conditions, including diseases and disorders, differential diagnoses, clinical algorithms, laboratory tests, and clinical practice guidelines?all carefully reviewed by experts in key clinical fields. Extensive algorithms, along with hundreds of high-quality photographs, illustrations, diagrams, and tables, ensure that you stay current with today's medical practice. Contains significant updates throughout all 5 sections, covering all aspects of diagnosis and treatment. Features 27 all-new topics including coronary artery dissection, perimandibular abscess, retinal vein occlusion, performance enhancing hormones, aphasia, hemorrhagic ovarian cyst, pelvic fracture, lung transplant, penile cancer and obsessive rumination syndrome, among others. Includes useful appendices covering care of the transgender patient, palliative care, preoperative evaluation, nutrition, poison management, commonly used herbal products in integrated medicine, and much more. Offers online access to Patient Teaching Guides in both English and Spanish.

Saunders Nursing Drug Handbook 2023 - E-Book

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Author :
Publisher : Elsevier Health Sciences
ISBN 13 : 0323932851
Total Pages : 1631 pages
Book Rating : 4.3/5 (239 download)

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Book Synopsis Saunders Nursing Drug Handbook 2023 - E-Book by : Robert Kizior

Download or read book Saunders Nursing Drug Handbook 2023 - E-Book written by Robert Kizior and published by Elsevier Health Sciences. This book was released on 2022-02-16 with total page 1631 pages. Available in PDF, EPUB and Kindle. Book excerpt: Ensure safe and effective drug therapy with this easy-to-use handbook! Saunders Nursing Drug Handbook 2023 provides you with current, detailed information on more than 1,000 generic and 4,000 trade name drugs. This handy, user-friendly guide includes updated uses, dosage forms, warnings, side effects and adverse reactions, IV drug administration, nursing considerations, and much more. Organized alphabetically by generic drug name for quick reference, this book stands out from the others in guiding the nurse through the steps essential to quality patient care. New drug monographs cover 25 new FDA-approved medications! More than 1,000 generic name drugs, encompassing over 4,000 trade name drugs, are organized alphabetically with A-to-Z tabs for quick and easy access. UNIQUE! Herbal information is included in the appendix and on the Evolve website, covering the interactions and effects of commonly encountered herbs. Detailed information for each drug includes side effects listed by frequency, and adverse effects and reactions requiring prompt intervention. Drugs by Disorder are listed in the front of the book for easy reference, showing common disorders and the drugs most often used for treatment. Drug Classifications section features an overview of actions and uses for drug families. Black Box Alerts and High Alert drugs are highlighted to promote safe administration of drugs that pose the greatest risk for patient harm, and Do Not Confuse With warnings call out drug names that sound alike or look alike. Top 100 Drugs list identifies the most frequently administered drugs. Cross-references to the 400 top U.S. brand-name drugs are located throughout the book for easy access. List of newly approved medications in the front of the book makes it easy to locate the latest drugs. Nursing considerations are organized in a functional nursing process framework and include baseline assessment, intervention/evaluation, and patient/family teaching. Information on lifespan and disorder-related dosage variations covers special considerations for pediatric, geriatric, hepatic, and immune- or renal-compromised patients. Extensive IV content includes IV compatibilities/IV incompatibilities and breaks down key information on reconstitution, rate of administration, and storage. IV Compatibility Chart foldout includes comprehensive compatibility information for 65 intravenous drugs. Fixed combinations are included in dosages of each combined drug directly within the individual monographs, to help students understand different drug dose options for specific diseases. Customizable and printable monographs for 100 of the most commonly used drugs are located on Evolve, along with quarterly drug updates.

HIV Essentials

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Author :
Publisher : Jones & Bartlett Learning
ISBN 13 : 1284291359
Total Pages : 383 pages
Book Rating : 4.2/5 (842 download)

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Book Synopsis HIV Essentials by : Paul E Sax

Download or read book HIV Essentials written by Paul E Sax and published by Jones & Bartlett Learning. This book was released on 2023-12-29 with total page 383 pages. Available in PDF, EPUB and Kindle. Book excerpt: The world's leading experts provide all the 'essentials' needed to manage HIV patients in the office, on the ward, and in the ICU. HIV Essentials incorporates the latest clinical guidelines into a step-by-step guide to the diagnosis, evaluation, management, and prevention of HIV infection and its complications. Topics include opportunistic infections and other HIV complications, treatment of HIV and pregnancy, antiretroviral drug summaries, post-exposure and pre-exposure prophylaxis, as well as commercially available dosage forms for all ARVs. The Tenth Edition was revised and updated to focus on treatment and prevention and has removed HCV content.

Liver Pathophysiology

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Author :
Publisher : Academic Press
ISBN 13 : 0128043210
Total Pages : 917 pages
Book Rating : 4.1/5 (28 download)

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Book Synopsis Liver Pathophysiology by : Pablo Muriel

Download or read book Liver Pathophysiology written by Pablo Muriel and published by Academic Press. This book was released on 2017-03-02 with total page 917 pages. Available in PDF, EPUB and Kindle. Book excerpt: Liver Pathophysiology: Therapies and Antioxidants is a complete volume on morphology, physiology, biochemistry, molecular biology and treatment of liver diseases. It uses an integral approach towards the role of free radicals in the pathogenesis of hepatic injury, and how their deleterious effects may be abrogated by the use of antioxidants. Written by the most prominent authors in the field, this book will be of use to basic and clinical scientists and clinicians working in the biological sciences, especially those dedicated to the study and treatment of liver pathologies. Presents the most recent advances in hepatology, with a special focus on the role of oxidative stress in liver injury. Provides in vivo and in vitro models to study human liver pathology. Explains the beneficial effects of antioxidants on liver diseases. Contains the most recent and modern treatments of hepatic pathologies, including, but not limited to, stem cells repopulation, gene therapy and liver transplantation.

CEN® Exam Prep Study Guide

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Author :
Publisher : Springer Publishing Company
ISBN 13 : 0826164064
Total Pages : 473 pages
Book Rating : 4.8/5 (261 download)

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Book Synopsis CEN® Exam Prep Study Guide by : Springer Publishing Company

Download or read book CEN® Exam Prep Study Guide written by Springer Publishing Company and published by Springer Publishing Company. This book was released on 2023-03-16 with total page 473 pages. Available in PDF, EPUB and Kindle. Book excerpt: CEN® Exam Prep Study Guide gets right to the point with a targeted content based on the latest BCEN® exam blueprint. This easy-to-follow guide includes all the tools you need to prepare, practice, and pass the exam—and nothing you don't. PREPARE Concise coverage of the content you'll be tested on. Quick-reference features with complications, alerts, and nursing pearls. Need-to-know information to prepare you for exam day. PRACTICE Two full-length practice tests—one in book and one online—to assess your readiness and simulate the test-taking experience. Detailed rationales for correct and incorrect answers. Pop quizzes that highlight key information you don't want to miss. PASS The first time with Springer Publishing Exam Prep's 100% Pass Guarantee. With confidence, knowing you're well-prepared with all the skills and knowledge you need on exam day and in practice. With pride in your commitment to patient health and safety. CEN® is a registered trademark of Board of Certification for Emergency Nursing (BCEN®). BCEN® does not sponsor or endorse this resource, nor does it have a proprietary relationship with Springer Publishing.

Conn's Current Therapy 2024

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Author :
Publisher : Elsevier Health Sciences
ISBN 13 : 0443121524
Total Pages : 1645 pages
Book Rating : 4.4/5 (431 download)

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Book Synopsis Conn's Current Therapy 2024 by : Rick D. Kellerman

Download or read book Conn's Current Therapy 2024 written by Rick D. Kellerman and published by Elsevier Health Sciences. This book was released on 2023-11-29 with total page 1645 pages. Available in PDF, EPUB and Kindle. Book excerpt: Trusted by clinicians for more than 75 years, Conn’s Current Therapy presents today’s evidence-based information along with the personal experience and discernment of expert physicians. The 2024 edition is a helpful resource for a wide range of healthcare providers, including primary care physicians, subspecialists, and allied health professionals, providing current treatment information in a concise yet in-depth format. Nearly 350 topics have been carefully reviewed and updated to bring you state-of-the-art content in even the most rapidly changing areas of medicine. Offers personal approaches from recognized leaders in the field, covering common complaints, acute diseases, and chronic illnesses along with the most current evidence-based clinical management options. Follows a consistent, easy-to-use format throughout, with diagnosis, therapy, drug protocols, and treatment pearls presented in quick-reference boxes and tables for point-of-care answers to common clinical questions. Incorporates electronic links throughout the text that connect the reader to apps and clinical prediction tools that can easily be accessed in practice. Features thoroughly reviewed and updated information from multiple expert authors and editors, who offer a fresh perspective and their unique personal experience and judgment. Provides current drug information thoroughly reviewed by PharmDs. Features nearly 300 images, including algorithms, anatomical illustrations, and photographs, that provide useful information for diagnosis.

Ferri's Clinical Advisor 2024

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Author :
Publisher : Elsevier Health Sciences
ISBN 13 : 0323755771
Total Pages : 5238 pages
Book Rating : 4.3/5 (237 download)

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Book Synopsis Ferri's Clinical Advisor 2024 by : Fred F. Ferri

Download or read book Ferri's Clinical Advisor 2024 written by Fred F. Ferri and published by Elsevier Health Sciences. This book was released on 2023-06-13 with total page 5238 pages. Available in PDF, EPUB and Kindle. Book excerpt: For more than 25 years, Ferri’s Clinical Advisor has provided immediate answers on the myriad medical diseases and disorders you’re likely to encounter in a unique, easy-to-use format. A bestselling title year after year, this popular "5 books in 1" reference delivers vast amounts of information in a user-friendly manner. It is updated annually to provide current and clinically relevant answers on over 1,000 common medical conditions, including diseases and disorders, differential diagnoses, clinical algorithms, laboratory tests, and clinical practice guidelines?all carefully reviewed by experts in key clinical fields. Extensive algorithms, along with hundreds of high-quality photographs, illustrations, diagrams, and tables, ensure that you stay current with today's medical practice. Contains significant updates throughout all 5 sections, covering all aspects of diagnosis and treatment. Features 26 all-new topics including monkeypox, occupational asthma, care of the transgender patient, infantile hypotonia, long-COVID, medical marijuana, cannabinoid use disorder, and abuse of performance enhancing hormones, among others. Includes useful appendices covering palliative care, preoperative evaluation, nutrition, poison management, commonly used herbal products in integrated medicine, and much more. Offers online access to Patient Teaching Guides in both English and Spanish.

Introduction to Clinical Pharmacology - E-Book

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Author :
Publisher : Elsevier Health Sciences
ISBN 13 : 0443115958
Total Pages : 491 pages
Book Rating : 4.4/5 (431 download)

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Book Synopsis Introduction to Clinical Pharmacology - E-Book by : Constance G Visovsky

Download or read book Introduction to Clinical Pharmacology - E-Book written by Constance G Visovsky and published by Elsevier Health Sciences. This book was released on 2023-12-18 with total page 491 pages. Available in PDF, EPUB and Kindle. Book excerpt: Learn the principles of pharmacology and administer drugs safely! Introduction to Clinical Pharmacology, 11th Edition provides the essential information that LPNs and vocational nurses need to administer medications in all practice settings. It shows how drugs and drug classes work, so you can understand why drugs are given and evaluate the expected response as well as side effects and adverse effects. In each drug category, an overview of the nursing process outlines the nurse’s role when administering drugs. This edition includes a new Drugs for Cancer Treatment chapter and Get Ready for the Next Generation NCLEX® Examination! case studies and questions to help you prepare for the newest version of the NCLEX exam. Written by an experienced team of authors led by Dr. Constance G. Visovsky, this book is the only pharmacology text designed specifically for LPN/LVNs. Ideal scope of content and readability for LPN/LVN programs provides illustrated, need-to-know pharmacology information, and includes a new Drugs for Cancer Treatment chapter. A focus on drug categories helps you understand the actions and uses of drug classes and provides a framework for safe, effective practice as new drugs are introduced to the market. Rationales accompany nursing actions, helping you understand why actions or precautions are necessary and to better communicate directions to patients and their families. Safety Alert boxes and Black Box Warnings highlight important nursing considerations for safe medication administration and monitoring. Lifespan Considerations boxes draw attention to information that is especially important when giving a specific drug to older adults, children, or pregnant/lactating women. Get Ready for the Next Generation NCLEX® Examination! section includes key points, review questions, and case studies with critical thinking questions to prepare you for the pharmacology questions on the NCLEX-PN® Exam. Top Tips for Safety and Memory Jogger features help you remember key information. Online video clips on medication administration procedures provide you with a visual reference for safe drug administration. Key terms include definitions and page references to help you improve terminology and language skills before you enter clinical practice. NEW! Drugs for Cancer Treatment chapter is added to this edition. NEW! Expanded and refocused chapters include Drugs for Reproductive Health, Drugs for Thyroid and Adrenal Problems, and Drugs for Osteoporosis. NEW! High Alert Drugs boxes are added. NEW! Updated and newly approved pharmaceutical treatments and drugs prepare students for practice, covering only the drugs and drug categories that apply to the LPN/LVN role. NEW! Answer key includes end-of-chapter questions, including answers to questions for the Next Generation NCLEX® (NGN) exam.

Adult-Gerontology Acute Care Practice Guidelines

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Author :
Publisher : Springer Publishing Company
ISBN 13 : 0826176186
Total Pages : 742 pages
Book Rating : 4.8/5 (261 download)

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Book Synopsis Adult-Gerontology Acute Care Practice Guidelines by : Catherine Harris, PhD, MBA, AG-ACNP

Download or read book Adult-Gerontology Acute Care Practice Guidelines written by Catherine Harris, PhD, MBA, AG-ACNP and published by Springer Publishing Company. This book was released on 2023-05-10 with total page 742 pages. Available in PDF, EPUB and Kindle. Book excerpt: Praise for the first edition from Doody's Medical Reviews- Score: 93 "This well-developed book provides acute care guidelines for the geriatric population in an easy-to-follow format that uses structural elements such as numbering and multilevel lists for each system. It is an excellent reference for advanced practice prepared clinicians to help identify, diagnose, and develop a treatment plan for acute health issues in older adults and geriatric patients." -Tho Nguyen, DNP, MSN, RN Newly updated, this evidence-based resource--the first of its kind--provides NPs, PAs, and other advance practice providers with the essential clinical knowledge they need to effectively practice adult-gerontology acute care. The second edition covers 10 new conditions and delivers numerous clinical updates on drugs, pain management, sedation, nutritional management, and clinical and screening guidelines. Along with relevant information on Covid-19, it examines more acid-base and neurological disorders and explains the use of Point of Care Ultrasound (POCUS). New unfolding case scenarios include questions to reinforce knowledge, and step-by-step procedural videos provide clear, detailed guidance. The addition of a section on Billing provides clinicians with a working understanding of this process. In quick reference format, this system-based text describes more than 100 common conditions health providers are likely to see in their acute care practice. With contributions from NPs, PAs, and physicians, it provides expert insight into each condition, enabling readers to categorize symptoms, be alert to the distinguishing features of disease symptoms and clusters, and locate associated diagnoses. This handy text also includes perioperative considerations, discharge guidelines, treatment and disease management algorithms, and procedural guidelines. Numerous clinical updates and clinical scenarios incorporated throughout the text validate knowledge and competency. Purchase includes digital access for use on most mobile devices or computers. New to the Second Edition: Provides updated information on drugs, pain management, moderate sedation, nutritional management, and clinical and screening guidelines Addresses new conditions Offers current information on Covid-19 Includes additional acid-base and neurological disorders Covers Point of Care Ultrasound (POCUS) Provides brief, unfolding case scenarios with questions to reinforce knowledge Addresses the basics of Billing Delivers NEW, step-by-step procedural videos demonstrating arterial line placement, digital nerve blocks, and lumbar puncture Key Features: Presents key points for more than 100 acute care conditions in quick-reference format Includes considerations for preoperative, intraoperative, and postoperative evaluation and management Offers discharge guidelines for inpatient conditions Disseminates over 20 procedural guidelines such as central and arterial line insertion, bronchoscopy, ECMO, endotracheal intubation, and more

CURRENT Medical Diagnosis and Treatment 2023

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Author :
Publisher : McGraw Hill Professional
ISBN 13 : 1264687745
Total Pages : 1874 pages
Book Rating : 4.2/5 (646 download)

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Book Synopsis CURRENT Medical Diagnosis and Treatment 2023 by : Maxine A. Papadakis

Download or read book CURRENT Medical Diagnosis and Treatment 2023 written by Maxine A. Papadakis and published by McGraw Hill Professional. This book was released on 2022-09-09 with total page 1874 pages. Available in PDF, EPUB and Kindle. Book excerpt: A Doody's Core Title for 2023! The #1 annual internal medicine guide―extensively revised and updated The most popular annual guide of its kind, this updated edition of the flagship title of the LANGE medical book brand presents the most important diagnostic and treatment recommendations as well as the most useful new clinical developments in every field of adult medicine. For 60+ years, CURRENT Medical Diagnosis & Treatment has been delivering the authoritative information that students, residents, and clinicians need to build their medical knowledge, expertise, and confidence. Written by top experts in their fields, this unmatched guide enables you to find the answers you need quickly and easily. It provides: Coverage of more than 1,000 diseases and disorders Comprehensive approach to patient care, focusing on diagnostic tools for day-to-day practice Hundreds of drug treatment tables for quick access to indexed trade names and updated drug prices Diagnostic and treatment algorithms to present important information at a glance Carefully curated, updated references to provide peer-reviewed, evidence-based information, and PMID numbers for quick online access Annual update on dynamic viral infections, including SARS-CoV-2/COVID-19 and HIV/AIDS Hundreds of full-color photographs, illustrations, and algorithms

FDA's Drug Review Process and the Package Label

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Author :
Publisher : Academic Press
ISBN 13 : 0128146486
Total Pages : 671 pages
Book Rating : 4.1/5 (281 download)

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Book Synopsis FDA's Drug Review Process and the Package Label by : Tom Brody

Download or read book FDA's Drug Review Process and the Package Label written by Tom Brody and published by Academic Press. This book was released on 2017-12-01 with total page 671 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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

Identification and Quantification of Drugs, Metabolites, Drug Metabolizing Enzymes, and Transporters

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Author :
Publisher : Elsevier Science
ISBN 13 : 0128200189
Total Pages : 708 pages
Book Rating : 4.1/5 (282 download)

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Book Synopsis Identification and Quantification of Drugs, Metabolites, Drug Metabolizing Enzymes, and Transporters by : Shuguang Ma

Download or read book Identification and Quantification of Drugs, Metabolites, Drug Metabolizing Enzymes, and Transporters written by Shuguang Ma and published by Elsevier Science. This book was released on 2020-07-24 with total page 708 pages. Available in PDF, EPUB and Kindle. Book excerpt: Identification and Quantification of Drugs, Metabolites, Drug Metabolizing Enzymes, and Transporters, Second Edition, is completely updated to provide an overview of the last decade's numerous advances in analytical technologies for detection and quantification of drugs, metabolites, and biomarkers. This new edition goes beyond LC-MS and features all-new chapters on how to evaluate drug absorption, distribution, metabolism, and excretion, potential for hepatic and renal toxicity, immunogenicity of biotherapeutics and translational tools for predicting human dosage, safety and efficacy of small molecules and biologics. This book will be an important handbook and desk reference for pharmacologists, toxicologists, clinical scientists, and students interested in the fields of pharmacology, biochemistry, and drug metabolism. Four sections in the book with 24 chapters give readers an overview of state-of-the-art techniques for identifying and quantifying drugs, metabolites and biomarkers, including a chapter on new approaches for quantification of enzymes and transporters in different tissues Focuses on the role of drug metabolism enzymes, transporters in disposition and drug-drug interactions, as well as strategies for evaluating drug metabolism and safety using advanced liver and kidney models. Discussions on immunogenicity risks of biologics and their evaluation methods have been included Includes several chapters on advanced translational sciences to predict human dosage, pharmacokinetics and efficacy for small molecules and biotherapeutics All chapters are written by experts with a wide range of practical experience from the industry and academia

Understanding Pharmacology - E-Book

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Author :
Publisher : Elsevier Health Sciences
ISBN 13 : 0323825745
Total Pages : 611 pages
Book Rating : 4.3/5 (238 download)

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Book Synopsis Understanding Pharmacology - E-Book by : M. Linda Workman

Download or read book Understanding Pharmacology - E-Book written by M. Linda Workman and published by Elsevier Health Sciences. This book was released on 2023-02-09 with total page 611 pages. Available in PDF, EPUB and Kindle. Book excerpt: NEW! Clinical Judgment questions at the end of each clinical chapter offer additional self-assessment on pharmacology and medication administration. NEW! Critical Point for Safety boxes emphasize very important pharmacologic concepts to remember. NEW! Approximately 40 animations on the companion Evolve website supplement important concepts related to understanding pharmacology. NEW! Printed answer key with rationales in the back of the book makes it easy to check your answers and assess your comprehension. UPDATED! Revised drug tables provide adult dosages and nursing implications for individual drugs.