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?
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
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.
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.
Download or read book Biosimilars of Monoclonal Antibodies written by Cheng Liu and published by John Wiley & Sons. This book was released on 2016-12-19 with total page 720 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
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
Download or read book Pharmaceutical Medicine and Translational Clinical Research written by Divya Vohora and published by Academic Press. This book was released on 2017-11-14 with total page 526 pages. Available in PDF, EPUB and Kindle. Book excerpt: Pharmaceutical Medicine and Translational Clinical Research covers clinical testing of medicines and the translation of pharmaceutical drug research into new medicines, also focusing on the need to understand the safety profile of medicine and the benefit-risk balance. Pharmacoeconomics and the social impact of healthcare on patients and public health are also featured. It is written in a clear and straightforward manner to enable rapid review and assimilation of complex information and contains reader-friendly features. As a greater understanding of these aspects is critical for students in the areas of pharmaceutical medicine, clinical research, pharmacology and pharmacy, as well as professionals working in the pharmaceutical industry, this book is an ideal resource. Includes detailed coverage of current trends and key topics in pharmaceutical medicine, including biosimilars, biobetters, super generics, and Provides a comprehensive look at current and important aspects of the science and regulation of drug and biologics discovery
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:
Download or read book Therapy for Severe Psoriasis E Book written by Jashin J. Wu and published by Elsevier Health Sciences. This book was released on 2016-12-02 with total page 352 pages. Available in PDF, EPUB and Kindle. Book excerpt: A brand-new title in the field of dermatology, Therapy for Severe Psoriasis provides the ultimate coverage of the treatment options available for today's most serious cases, including biologics and oral therapies. It features discussions of the newest drug therapies, recent FDA-approved biosimilars, and combination approaches to care, while an overview chapter was designed to aid those new to the field in understanding the nuances of difficult-to-treat subtypes of psoriasis. Comprehensive and focused, Therapy for Severe Psoriasis will be a welcome addition to the library of any dermatologist seeking in-depth information on the challenges of this condition. Each of the 16 chapters includes either an in-depth focus on a single therapy or an overview of a unique aspect of psoriasis, including: UVB therapy, methotrexate, acitretin, cyclosporine, apremilast, etanercept, infliximab, adalimumab, ustekinumab, secukinumab, and ixekizumab. Takes an evidence-based approach to hard-to-treat severe psoriasis. Discusses the newest drug therapies (such as ixekizumab), plus recent FDA-approved biosimilars, a topic unique to this particular psoriasis text. Presents combination approaches for instances when standard treatments are not successful. Includes an overview chapter to help beginners understand the nuances of the disorder.
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
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
Download or read book Remington written by Adeboye Adejare and published by Academic Press. This book was released on 2020-11-03 with total page 1032 pages. Available in PDF, EPUB and Kindle. Book excerpt: The PCP's Bicentennial Edition Remington: The Science and Practice of Pharmacy, Twenty Third Edition, offers a trusted, completely updated source of information for education, training, and development of pharmacists. Published for the first time with Elsevier, this edition includes coverage of biologics and biosimilars as uses of those therapeutics have increased substantially since the previous edition. Also discussed are formulations, drug delivery (including prodrugs, salts, polymorphism. With clear, detailed color illustrations, fundamental information on a range of pharmaceutical science areas, and information on new developments in industry, pharmaceutical industry scientists, especially those involved in drug discovery and development will find this edition of Remington an essential reference. Intellectual property professionals will also find this reference helpful to cite in patents and resulting litigations. Additional graduate and postgraduate students in Pharmacy and Pharmaceutical Sciences will refer to this book in courses dealing with medicinal chemistry and pharmaceutics. Contains a comprehensive source of principles of drug discovery and development topics, especially for scientists that are new in the pharmaceutical industry such as those with trainings/degrees in chemistry and engineering Provides a detailed source for formulation scientists and compounding pharmacists, from produg to excipient issues Updates this excellent source with the latest information to verify facts and refresh on basics for professionals in the broadly defined pharmaceutical industry
Download or read book Health at a Glance 2021 OECD Indicators written by OECD and published by OECD Publishing. This book was released on 2021-11-09 with total page 275 pages. Available in PDF, EPUB and Kindle. Book excerpt: Health at a Glance provides a comprehensive set of indicators on population health and health system performance across OECD members and key emerging economies. This edition has a special focus on the health impact of COVID-19 in OECD countries, including deaths and illness caused by the virus, adverse effects on access and quality of care, and the growing burden of mental ill-health.
Download or read book The Challenge of CMC Regulatory Compliance for Biopharmaceuticals written by John Geigert and published by Springer. This book was released on 2019-05-08 with total page 426 pages. Available in PDF, EPUB and Kindle. Book excerpt: Biopharmaceuticals (i.e., biological medicines sourced from genetically-engineered living systems) for treatment of human diseases have become a significant percentage of the pharmaceutical industry. And not just the recombinant DNA-derived proteins and monoclonal antibodies (both from the innovators and biosimilars); but now, an increasing awareness of the importance of gene therapy and genetically engineered cellular medicinal products. These biopharmaceuticals are being developed by many companies whose Chemistry, Manufacturing & Control (CMC) teams have varying degrees of familiarity or experience with the CMC strategy and regulatory compliance requirements for these challenging products. Companies clearly plan out the strategy for their clinical study plans, but frequently, the development of a strategy for CMC is an afterthought. Coupled with the complexity of the biopharmaceutical manufacturing processes and products, and this can be a recipe for disaster. The third edition of this book provides insights and practical guidance for the CMC teams to develop an acceptable cost-effective, risk-based CMC regulatory compliance strategy for all biopharmaceuticals (recombinant proteins, monoclonal antibodies, genetically engineered viruses and genetically engineered human cells) from early clinical stage development through market approval. The third edition of this book provides added coverage for the biosimilars, antibody drug conjugates (ADCs), bispecific antibodies, genetically engineered viruses, and genetically engineered cells. This third edition of the book also addresses the heightened pressure on CMC regulatory compliance timelines due to the introduction of expedited clinical pathways moving the clinical development closer to a seamless phase process (e.g., FDA Breakthrough Therapy designation, CBER Regenerative Medicine Advanced Therapy (RMAT) designation, EMA Priority Medicines (PRIME) designation). The Challenge of CMC Regulatory Compliance for Biopharmaceuticals is essential, practical information for all pharmaceutical development scientists, Manufacturing and Quality Unit staff, Regulatory Affairs personnel, and senior management involved in the manufacture of biopharmaceuticals.
Download or read book Principles and Practice of Clinical Trials written by Steven Piantadosi and published by Springer Nature. This book was released on 2022-07-19 with total page 2573 pages. Available in PDF, EPUB and Kindle. Book excerpt: This is a comprehensive major reference work for our SpringerReference program covering clinical trials. Although the core of the Work will focus on the design, analysis, and interpretation of scientific data from clinical trials, a broad spectrum of clinical trial application areas will be covered in detail. This is an important time to develop such a Work, as drug safety and efficacy emphasizes the Clinical Trials process. Because of an immense and growing international disease burden, pharmaceutical and biotechnology companies continue to develop new drugs. Clinical trials have also become extremely globalized in the past 15 years, with over 225,000 international trials ongoing at this point in time. Principles in Practice of Clinical Trials is truly an interdisciplinary that will be divided into the following areas: 1) Clinical Trials Basic Perspectives 2) Regulation and Oversight 3) Basic Trial Designs 4) Advanced Trial Designs 5) Analysis 6) Trial Publication 7) Topics Related Specific Populations and Legal Aspects of Clinical Trials The Work is designed to be comprised of 175 chapters and approximately 2500 pages. The Work will be oriented like many of our SpringerReference Handbooks, presenting detailed and comprehensive expository chapters on broad subjects. The Editors are major figures in the field of clinical trials, and both have written textbooks on the topic. There will also be a slate of 7-8 renowned associate editors that will edit individual sections of the Reference.
Download or read book Global Pharmaceutical Policy written by Zaheer-Ud-Din Babar and published by Springer Nature. This book was released on 2020-06-15 with total page 376 pages. Available in PDF, EPUB and Kindle. Book excerpt: Medicines are vital in improving patient health outcomes and pharmaceutical policy is a fundamental component of any health system. However, the global pharmaceutical policy is ever-evolving and data and quality ‘research-based information’ in this field are scarce. This book fills this gap and provides up-to-date empirical information and evidence-based synthesis. It focuses on pertinent key issues in global pharmaceutical policy including medicines safety, generic medicines, pharmaceutical supply chain, medicines financing, access and affordability of medicines, rational use of medicines, pharmacy health services research and access to vaccines and biological products. Featuring policy case studies from varied countries such as Mexico, Russia, China, Kyrgyzstan, and Pakistan, this book comprises a valuable and comprehensive resource for students, funders, policymakers, academics, and researchers interested in this field.
Download or read book Approved Prescription Drug Products with Therapeutic Equivalence Evaluations written by and published by . This book was released on 1984 with total page 336 pages. Available in PDF, EPUB and Kindle. Book excerpt: Accompanied by supplements.
