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Fast Facts Biosimilars
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Book Synopsis Fast Facts: Biosimilars by : Paul Cornes
Download or read book Fast Facts: Biosimilars written by Paul Cornes and published by Karger Medical and Scientific Publishers. This book was released on 2018-04-09 with total page 72 pages. Available in PDF, EPUB and Kindle. Book excerpt: Biosimilars have been in clinical use for more than 10 years, and evidence from more than 700 million patient-days’ exposure shows that approved biosimilars can be used as safely and effectively as their originator biologics. And yet concerns about these drugs persist, particularly in therapy areas where they are recent additions to the formulary. It is vital to address these concerns so that clinicians can prescribe biosimilars with confidence, realizing substantial cost savings and improving patient access to effective treatments. 'Fast Facts: Biosimilars' provides a comprehensive yet concise explanation of biosimilars: what they are, how they are regulated, and how they are used in clinical practice. It is ideal for healthcare professionals and decision makers who want to understand biosimilars and the key concerns and controversies around these valuable products. Contents: 1 - An introduction to biologics and biosimilars 2 - Why do we need biosimilars? 3 - How is the quality of biosimilars assured? 4 - How is the efficacy and safety of biosimilars ensured? 5 - What has been the experience with biosimilars to date? 6 - The future of biosimilar medicines 7 - How do I use biosimilar medicines?
Book Synopsis Fast Facts: Biosimilars in Hematology and Oncology by : P. Cornes
Download or read book Fast Facts: Biosimilars in Hematology and Oncology written by P. Cornes and published by Karger Medical and Scientific Publishers. This book was released on 2020-01-24 with total page 130 pages. Available in PDF, EPUB and Kindle. Book excerpt: Biologics have revolutionized – and are revolutionizing – the treatment of many serious disorders. The evidence acquired from more than 10 years of clinical experience, with more than 50 biosimilar drugs and more than 700 million patient-days' exposure in Europe, shows that approved biosimilars can be used as safely and effectively as originator biologics. Yet concerns persist about biosimilars – particularly in curative cancer treatment, where they are relatively recent therapeutic options. 'Fast Facts: Biosimilars in Hematology and Oncology' provides a concise overview of emerging global practice in this fast-moving area together with practical information on adding biosimilars to a formulary and switching patients. Contents: • Biologics and the need for biosimilars • Why do we need biosimilars? • How is the quality of biosimilar medicines assured? • Legal issues • Switching, interchangeability and extrapolation • Safety and pharmacovigilant • Global issues • Formulary considerations: pharmacy issues • Formulary considerations: supportive care biosimilars • Formulary considerations: therapeutic anti-cancer biosimilars • Communication and awareness
Book Synopsis Fast Facts: Biosimilars by : Guy Regnard
Download or read book Fast Facts: Biosimilars written by Guy Regnard and published by Karger Medical and Scientific Publishers. This book was released on 2024-09-25 with total page 161 pages. Available in PDF, EPUB and Kindle. Book excerpt: Biologic medicines have revolutionized the treatment of many serious disorders. Biosimilars offer similar safety and efficacy at a fraction of the cost, though while they have led to significant savings, uptake varies globally due to concerns and regulatory inconsistencies, especially in middle-income countries where the need for affordable drugs is greatest. 'Fast Facts: Biosimilars: A Global Perspective' has taken a specifically global perspective, with expert contributors invited to represent a range of medical specialties, including endocrinology, hematology, oncology and immunology, and regions of the world. It addresses the following concerns, drawing on the most up-to-date information in this fast-moving area of medicine:
Is the quality of the biosimilar medicine equivalent to that of the original drug?
Is the biosimilar medicine safe?
Which indications can the biosimilar medicine be used for?
What are the realistic economic benefits?
How do I switch a patient from a biologic to an equivalent biosimilar medicine?
How do I select biologics in a region with regulatory uncertainty over biosimilars?
Book Synopsis Fast Facts: Biosimilares by : P. Cornes
Download or read book Fast Facts: Biosimilares written by P. Cornes and published by Karger Medical and Scientific Publishers. This book was released on 2019-09-30 with total page 78 pages. Available in PDF, EPUB and Kindle. Book excerpt: Los biosimilares han estado en uso clínico durante más de 10 años, y la evidencia de exposición de más de 700 millones de días-paciente muestra que los biosimilares aprobados pueden usarse de manera tan segura y efectiva como sus productos biológicos originales. Y sin embargo, persisten las preocupaciones sobre estos medicamentos, especialmente en las áreas terapéuticas donde han sido recientemente incluidos a los formularios. Es de vital importancia abordar estas inquietudes para que los médicos puedan prescribir los biosimilares con confianza, dándose cuenta de los ahorros en costos y mejorando el acceso de los pacientes a tratamientos eficaces. 'Fast Facts: Biosimilares' proporciona una explicación completa pero concisa de los biosimilares: qué son, cómo se regulan y la forma en que se utilizan en la práctica clínica. Es ideal para los profesionales de la salud y tomadores de decisiones que desean comprender a los biosimilares y las principales preocupaciones y controversias en torno a estos valiosos productos.
Author : Publisher :Karger Medical and Scientific Publishers ISBN 13 :3318073830 Total Pages :161 pages Book Rating :4.3/5 (18 download)
Download or read book written by and published by Karger Medical and Scientific Publishers. This book was released on with total page 161 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Book Synopsis Fast Facts: Psoriasis by : Alan Menter
Download or read book Fast Facts: Psoriasis written by Alan Menter and published by Karger Medical and Scientific Publishers. This book was released on 2014-10-01 with total page 122 pages. Available in PDF, EPUB and Kindle. Book excerpt: Psoriasis can no longer be considered a mere skin disease - it is a spectrum of different conditions requiring a spectrum of different treatments. Yet the systemic and psychosocial consequences of the condition often go unrecognized. The fourth edition of this refreshingly readable handbook explores the potential to improve the quality of life of patients by reducing the range of comorbidities associated with psoriasis, including arthritis, cardiovascular disease and inflammatory bowel disease. Fast Facts: Psoriasis is packed with practical information on all aspects of this increasingly treatable disease, including: • a concise review of the immunologic and genetic aspects of the disease • a well-illustrated guide to clinical presentation and differential diagnosis • all management options, from topical treatments to current and emerging receptor-targeted therapies • a commonsense approach to management by rotating and combining therapies • a fully updated chapter on psoriatic arthritis 'Fast Facts: Psoriasis' is essential reading for the primary care team, dermatology trainees and specialists in cardiology, gastroenterology and rheumatology who want to learn all about psoriasis but have little time to spare. Contents: • Epidemiology and pathophysiology • Clinical presentation • Differential diagnosis • General management approach • Topical Therapy • Phototherapy and photochemotherapy • Systemic therapy • Receptor-targeted (biological) therapies • Psoriatic arthritis • Future trends • Useful resources
Author :David S. Rampton Publisher :Karger Medical and Scientific Publishers ISBN 13 :1910797138 Total Pages :153 pages Book Rating :4.9/5 (17 download)
Book Synopsis Fast Facts: Inflammatory Bowel Disease by : David S. Rampton
Download or read book Fast Facts: Inflammatory Bowel Disease written by David S. Rampton and published by Karger Medical and Scientific Publishers. This book was released on 2016-10-17 with total page 153 pages. Available in PDF, EPUB and Kindle. Book excerpt: Ulcerative colitis and Crohn's disease, referred to collectively as inflammatory bowel disease (IBD), are chronic debilitating disorders. IBD, particularly Crohn's disease, is increasing everywhere, most notably in the Western world where about 1 in 200 people now has the condition. This highly readable, 'zippy' fifth edition of 'Fast Facts: Inflammatory Bowel Disease' provides succinct yet thorough information that will aid early recognition of these disorders and their complications, alongside practical holistic management advice. With important emphasis on the doctor–patient relationship and effective multidisciplinary services, 'Fast Facts: Inflammatory Bowel Disease' is an invaluable resource for all primary care providers, hospital doctors in training, nurses, stoma therapists, dieticians, psychologists, counselors and social workers; in fact, all health professionals involved in the care of patients with IBD, as well as patients who wish to know more about their condition. Contents: • Etiopathogenesis • Clinical features and intestinal complications • Extraintestinal manifestations and complications • Diagnosis • Drugs used to treat inflammatory bowel disease • Principles of management • Medical management of ulcerative colitis • Medical management of Crohn’s disease • Surgery • IBD in pregnancy, childhood and old age • Prognosis
Book Synopsis Biosimilars of Monoclonal Antibodies by : Cheng Liu
Download or read book Biosimilars of Monoclonal Antibodies written by Cheng Liu and published by John Wiley & Sons. This book was released on 2016-12-09 with total page 723 pages. Available in PDF, EPUB and Kindle. Book excerpt: Addressing a significant need by describing the science and process involved to develop biosimilars of monoclonal antibody (mAb) drugs, this book covers all aspects of biosimilar development: preclinical, clinical, regulatory, manufacturing. • Guides readers through the complex landscape involved with developing biosimilar versions of monoclonal antibody (mAb) drugs • Features flow charts, tables, and figures that clearly illustrate processes and makes the book comprehensible and accessible • Includes a review of FDA-approved mAb drugs as a quick reference to facts and useful information • Examines new technologies and strategies for improving biosimilar mAbs
Book Synopsis Guide to Biosimilars Litigation and Regulation in the U.S. by :
Download or read book Guide to Biosimilars Litigation and Regulation in the U.S. written by and published by . This book was released on 2022 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Author :Agency for Healthcare Research and Quality/AHRQ Publisher :Government Printing Office ISBN 13 :1587634333 Total Pages :385 pages Book Rating :4.5/5 (876 download)
Book Synopsis Registries for Evaluating Patient Outcomes by : Agency for Healthcare Research and Quality/AHRQ
Download or read book Registries for Evaluating Patient Outcomes written by Agency for Healthcare Research and Quality/AHRQ and published by Government Printing Office. This book was released on 2014-04-01 with total page 385 pages. Available in PDF, EPUB and Kindle. Book excerpt: This User’s Guide is intended to support the design, implementation, analysis, interpretation, and quality evaluation of registries created to increase understanding of patient outcomes. For the purposes of this guide, a patient registry is an organized system that uses observational study methods to collect uniform data (clinical and other) to evaluate specified outcomes for a population defined by a particular disease, condition, or exposure, and that serves one or more predetermined scientific, clinical, or policy purposes. A registry database is a file (or files) derived from the registry. Although registries can serve many purposes, this guide focuses on registries created for one or more of the following purposes: to describe the natural history of disease, to determine clinical effectiveness or cost-effectiveness of health care products and services, to measure or monitor safety and harm, and/or to measure quality of care. Registries are classified according to how their populations are defined. For example, product registries include patients who have been exposed to biopharmaceutical products or medical devices. Health services registries consist of patients who have had a common procedure, clinical encounter, or hospitalization. Disease or condition registries are defined by patients having the same diagnosis, such as cystic fibrosis or heart failure. The User’s Guide was created by researchers affiliated with AHRQ’s Effective Health Care Program, particularly those who participated in AHRQ’s DEcIDE (Developing Evidence to Inform Decisions About Effectiveness) program. Chapters were subject to multiple internal and external independent reviews.
Download or read book Biosimilars written by Hiten J. Gutka and published by Springer. This book was released on 2018-12-13 with total page 709 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book provides a comprehensive overview of the biosimilar regulatory framework, the development process and clinical aspects for development of biosimilars. The development path of a biosimilar is just as unique as a development path of a new drug, tailored by the mechanism of action, the quality of the molecule, published information on the reference product, the current competitive environment, the target market and regulatory guidance, and most importantly, the emerging totality of evidence for the proposed biosimilar during development. For the ease of readers, the book comprises of six sections as follows: Section I: Business, Health Economics and Intellectual Property Landscape for Biosimilars Section II: Regulatory Aspects of Development and Approval for Biosimilars Section III: Biopharmaceutical Development and Manufacturing of Biosimilars Section IV: Analytical Similarity Considerations for Biosimilars Section V: Clinical aspects of Biosimilar Development Section VI: Biosimilars- Global Development and Clinical Experience Chapters have been written by one or more experts from academia, industry or regulatory agencies who have been involved with one or more aspects of biosimilar product development. The authors and editors have an expertise in commercialization and pricing of biosimilars, intellectual property considerations for biosimilars, chemistry manufacturing controls (CMC) and analytical development for biosimilars, regulatory and clinical aspects of biosimilar development. Besides the industry practitioners, the book includes several contributions from regulators across the globe.
Author :National Academies of Sciences, Engineering, and Medicine Publisher :National Academies Press ISBN 13 :0309487811 Total Pages :69 pages Book Rating :4.3/5 (94 download)
Book Synopsis Continuous Manufacturing for the Modernization of Pharmaceutical Production by : National Academies of Sciences, Engineering, and Medicine
Download or read book Continuous Manufacturing for the Modernization of Pharmaceutical Production written by National Academies of Sciences, Engineering, and Medicine and published by National Academies Press. This book was released on 2019-04-05 with total page 69 pages. Available in PDF, EPUB and Kindle. Book excerpt: On July 30-31, 2018, the National Academies of Sciences, Engineering, and Medicine held a workshop titled Continuous Manufacturing for the Modernization of Pharmaceutical Production. This workshop discussed the business and regulatory concerns associated with adopting continuous manufacturing techniques to produce biologics such as enzymes, monoclonal antibodies, and vaccines. The participants also discussed specific challenges for integration across the manufacturing system, including upstream and downstream processes, analytical techniques, and drug product development. The workshop addressed these challenges broadly across the biologics domain but focused particularly on drug categories of greatest FDA and industrial interest such as monoclonal antibodies and vaccines. This publication summarizes the presentations and discussions from the workshop.
Book Synopsis Fast Facts: Postmenopausal Osteoporosis by : Elaine Dennison
Download or read book Fast Facts: Postmenopausal Osteoporosis written by Elaine Dennison and published by Karger Medical and Scientific Publishers. This book was released on 2021-11-30 with total page 64 pages. Available in PDF, EPUB and Kindle. Book excerpt: Fractures resulting from osteoporosis are increasingly common in postmenopausal women, resulting in substantial bone-associated morbidities, and increased mortality and healthcare costs. Despite well-established treatment guidelines, there is an urgent need to improve the recognition of women at high risk for fracture and their treatment. 'Fast Facts: Postmenopausal Osteoporosis' provides an overview of current clinical guidelines and addresses the reasons cited for suboptimal fracture prevention. Finally, but importantly, best practice regarding patient support is described. This concise educational resource is ideal for any primary care practitioner involved in the diagnosis and treatment of patients with postmenopausal osteoporosis. Table of Contents: • Age-related changes affecting bone • Epidemiology • Screening and estimating risk • Diagnosis and assessment • Pharmacological management • Non-pharmacological management • Patient support
Book Synopsis Guide for Aviation Medical Examiners by :
Download or read book Guide for Aviation Medical Examiners written by and published by . This book was released on 1992 with total page 256 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Book Synopsis Biologics, Biosimilars, and Biobetters by : Iqbal Ramzan
Download or read book Biologics, Biosimilars, and Biobetters written by Iqbal Ramzan and published by John Wiley & Sons. This book was released on 2021-02-03 with total page 328 pages. Available in PDF, EPUB and Kindle. Book excerpt: A comprehensive primer and reference, this book provides pharmacists and health practitioners the relevant science and policy concepts behind biologics, biosimilars, and biobetters from a practical and clinical perspective. Explains what pharmacists need to discuss the equivalence, efficacy, safety, and risks of biosimilars with physicians, health practitioners, and patients about Guides regulators on pragmatic approaches to dealing with these drugs in the context of rapidly evolving scientific and clinical evidence Balances scientific information on complex drugs with practical information, such as a checklist for pharmacists
Book Synopsis Promoting Access to Medical Technologies and Innovation - Intersections between Public Health, Intellectual Property and Trade by : World Intellectual Property Organization
Download or read book Promoting Access to Medical Technologies and Innovation - Intersections between Public Health, Intellectual Property and Trade written by World Intellectual Property Organization and published by WIPO. This book was released on 2013 with total page 259 pages. Available in PDF, EPUB and Kindle. Book excerpt: This study has emerged from an ongoing program of trilateral cooperation between WHO, WTO and WIPO. It responds to an increasing demand, particularly in developing countries, for strengthened capacity for informed policy-making in areas of intersection between health, trade and IP, focusing on access to and innovation of medicines and other medical technologies.
Download or read book Biological Drugs written by Amit Sengupta and published by . This book was released on 2018 with total page 38 pages. Available in PDF, EPUB and Kindle. Book excerpt:
