Fast Facts Biosimilars In Hematology And Oncology

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Fast Facts: Biosimilars in Hematology and Oncology

P. Cornes,A. McBride
Fast Facts Biosimilars in Hematology and Oncology Book PDF

Author : P. Cornes,A. McBride
Publisher : Karger Medical and Scientific Publishers
Page : 130 pages
File Size : 51,9 Mb
Release : 2020-01-24
Category : Medical
ISBN : 9781912776221

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Fast Facts: Biosimilars in Hematology and Oncology by P. Cornes,A. McBride Pdf

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

Fast Facts: Biosimilars

Paul Cornes,David J. Bennett
Fast Facts Biosimilars Book PDF

Author : Paul Cornes,David J. Bennett
Publisher : Karger Medical and Scientific Publishers
Page : 72 pages
File Size : 55,6 Mb
Release : 2018-04-09
Category : Medical
ISBN : 9781910797679

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Fast Facts: Biosimilars by Paul Cornes,David J. Bennett Pdf

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?

Fast Facts: Clinical Trials in Oncology

A. Hackshaw,G.C.E. Stuart
Fast Facts Clinical Trials in Oncology Book PDF

Author : A. Hackshaw,G.C.E. Stuart
Publisher : Karger Medical and Scientific Publishers
Page : 120 pages
File Size : 55,9 Mb
Release : 2020-12-18
Category : Medical
ISBN : 9781912776740

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Fast Facts: Clinical Trials in Oncology by A. Hackshaw,G.C.E. Stuart Pdf

Written by leading experts, 'Fast Facts: Clinical Trials in Oncology' will enhance the reader’s ability to critically evaluate published evidence. Assuming little or no prior knowledge, the book sets out clearly the fundamental features of clinical trials. The key attributes of Phase I–III trials of pharmaceutical products are described, as are trials of surgical procedures, radiation therapy and advanced therapies. The processes and documentation required to set up and conduct a trial are outlined, and the authors describe how trial data and real-world evidence are used to improve care. Although this concise colorful book focuses on oncology, the principles apply equally to interventions in other areas of practice. It will prove invaluable to medical, pharmaceutical and allied health professionals who want, or need, an overview of how contemporary clinical trials are designed and conducted.

Safety of Biologics Therapy

Brian A. Baldo
Safety of Biologics Therapy Book PDF

Author : Brian A. Baldo
Publisher : Springer
Page : 610 pages
File Size : 53,7 Mb
Release : 2016-08-12
Category : Medical
ISBN : 9783319304724

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Safety of Biologics Therapy by Brian A. Baldo Pdf

This long overdue title provides a comprehensive, up-to-date, state-of-the art review of approved biologic therapies, with coverage of mechanisms of action, Indications for therapy, immunogenicity and a detailed examination of adverse effects and safety of the many and diverse therapeutic agents presented in a total of 13 chapters. It is predicted that by 2016, biologics will make up half of the world's 20 top-selling drugs and by 2018, biologic medicine sales will account for almost half of the world's 100 biggest selling drugs. Recombinant proteins dominate the growing list of the more than 200 approved biotherapeutic agents with targeted antibodies, fusion proteins and receptors; cytokines; hormones; enzymes; proteins involved in blood-clotting, homeostasis and thrombosis; vaccines; botulinum neurotoxins; and, more recently, biosimilar preparations, comprising the majority of approved biologics. Written with clinicians, other health care professionals, and researchers in mind, Safety of Biologics Therapy examines, in a single volume, the full range of issues surrounding the safety of approved biologic therapies. A good understanding of the risks and safety issues of modern biologics therapy is increasingly being demanded of all those connected with their development, handling, prescribing, administration and subsequent patient management. In addition to being of great value to clinicians in all branches of medicine, and to nurses, pharmacists and researchers, this book will prove invaluable for students taking undergraduate and graduate courses in the above disciplines and in the biomedical sciences.

The Economics of Cancer Care

Nicholas Bosanquet,Karol Sikora
The Economics of Cancer Care Book PDF

Author : Nicholas Bosanquet,Karol Sikora
Publisher : Cambridge University Press
Page : 175 pages
File Size : 40,9 Mb
Release : 2006-03-23
Category : Medical
ISBN : 9781139450713

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The Economics of Cancer Care by Nicholas Bosanquet,Karol Sikora Pdf

This 2006 book examines the interaction of economics and the delivery of cancer care in the global context. It analyses the causes of tension between those paying for care, those providing the care and those marketing drugs and devices. The concept and requirement for rationing is examined in different economic environments. As cancer increases in incidence and prevalence, the economics of providing care becomes a more important subject than ever before. Written by a leading health economist and oncologist, this was the first comprehensive book on the economics of cancer care continues to be of interest to health professionals and policy makers alike.

Biologic and Systemic Agents in Dermatology

Paul S. Yamauchi
Biologic and Systemic Agents in Dermatology Book PDF

Author : Paul S. Yamauchi
Publisher : Springer
Page : 574 pages
File Size : 43,9 Mb
Release : 2018-01-02
Category : Medical
ISBN : 9783319668840

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Biologic and Systemic Agents in Dermatology by Paul S. Yamauchi Pdf

Written by leading experts in the field and designed for dermatologists and residents, this book includes evidence-based medicine that underscores the clinical data, as well as practical tips on how to use both biologic and systemic agents in the field of dermatology. In the past decade, there have been several groundbreaking advances in medical dermatology. Novel biologic and systemic agents have been developed to treat inflammatory disorders, including psoriasis and atopic dermatitis, as well as skin malignancies such as melanoma. Biologic and Systemic Agents in Dermatology encompasses these developments by describing the mechanism of action of these various agents and the clinical efficacy and safety to treating these respective disorders. The utilization of biologic and systemic agents in other dermatologic conditions, pharmacoeconomics, pharmacovigilance, and clinical trials outcomes are discussed as well as topics including tumor necrosis, conventional systemic agents for psoriatic disease, and oral agents for atopic dermatitis.

Fast Facts: Postmenopausal Osteoporosis

Elaine Dennison,Michael Clynes
Fast Facts Postmenopausal Osteoporosis Book PDF

Author : Elaine Dennison,Michael Clynes
Publisher : Karger Medical and Scientific Publishers
Page : 64 pages
File Size : 44,7 Mb
Release : 2021-11-30
Category : Medical
ISBN : 9783318070231

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Fast Facts: Postmenopausal Osteoporosis by Elaine Dennison,Michael Clynes Pdf

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

Biologics, Biosimilars, and Biobetters

Iqbal Ramzan
Biologics Biosimilars and Biobetters Book PDF

Author : Iqbal Ramzan
Publisher : John Wiley & Sons
Page : 328 pages
File Size : 48,9 Mb
Release : 2021-02-03
Category : Medical
ISBN : 9781119564652

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Biologics, Biosimilars, and Biobetters by Iqbal Ramzan Pdf

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

HER2-Positive Breast Cancer

Sara Hurvitz,Kelly McCann
HER2 Positive Breast Cancer Book PDF

Author : Sara Hurvitz,Kelly McCann
Publisher : Elsevier Health Sciences
Page : 264 pages
File Size : 43,7 Mb
Release : 2018-07-26
Category : Medical
ISBN : 9780323581233

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HER2-Positive Breast Cancer by Sara Hurvitz,Kelly McCann Pdf

Get a quick, expert overview of clinically-focused topics and guidelines that are relevant to testing for HER2, which contributes to approximately 25% of breast cancers today. This concise resource by Drs. Sara Hurvitz, and Kelly McCann consolidates today’s available information on this growing topic into one convenient resource, making it an ideal, easy-to-digest reference for practicing and trainee oncologists.

Cardiac Arrhythmias

Gerry Kaye,Steve Furniss,Robert Lemery
Cardiac Arrhythmias Book PDF

Author : Gerry Kaye,Steve Furniss,Robert Lemery
Publisher : Health Press (UK)
Page : 0 pages
File Size : 53,5 Mb
Release : 2009-06
Category : Arrhythmia
ISBN : 1903734886

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Cardiac Arrhythmias by Gerry Kaye,Steve Furniss,Robert Lemery Pdf

The diagnosis and management of heart rhythm abnormalities is often viewed as a complex and inaccessible area of modern cardiology shrouded in technical detail. Fast Facts: Cardiac Arrhythmias demystifies the subject with a straightforward approach to rhythm abnormality, asking how the patient with arrhythmia presents, how the problem should be investigated and how the arrhythmia can be managed. Highlights include:- A succinct description of normal conduction- A simple classification of arrhythmias based on 12-lead ECG patterns- A concise explanation of the mechanisms of arrhythmias with clear well-annotated illustrations- A comprehensive review of presenting signs and symptoms, with key questions to ask the patient- A logical approach to investigation: predict it (history and examination), wait for it (monitoring) or provoke it (electrophysiological testing)- Practical information on management options: pharmacological therapy, direct cardioversion, catheter ablation and cardiac devices- Specific chapters on the different types of arrhythmia

Immunogenicity of Biopharmaceuticals

Marco Weert,Eva Horn Møller
Immunogenicity of Biopharmaceuticals Book PDF

Author : Marco Weert,Eva Horn Møller
Publisher : Springer Science & Business Media
Page : 266 pages
File Size : 46,9 Mb
Release : 2008-02-06
Category : Medical
ISBN : 9780387758411

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Immunogenicity of Biopharmaceuticals by Marco Weert,Eva Horn Møller Pdf

Immunogenicity of Biopharmaceuticals is the first book to comprehensively address the potential of an immune response to biopharmaceuticals. It is intended to give a broad overview of the current state-of-the-art regarding this subject. The chapters range from an overview of the immune system and factors that may trigger the immune system, via detection of antibodies and clinical implications, to various case examples and the regulatory view on immunogenicity.

Biosimilar Clinical Development: Scientific Considerations and New Methodologies

Kerry B. Barker,Sandeep M. Menon,Ralph B. D'Agostino, Sr.,Siyan Xu,Bo Jin, PhD
Biosimilar Clinical Development Scientific Considerations and New Methodologies Book PDF

Author : Kerry B. Barker,Sandeep M. Menon,Ralph B. D'Agostino, Sr.,Siyan Xu,Bo Jin, PhD
Publisher : CRC Press
Page : 269 pages
File Size : 54,5 Mb
Release : 2016-11-25
Category : Mathematics
ISBN : 9781482231700

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Biosimilar Clinical Development: Scientific Considerations and New Methodologies by Kerry B. Barker,Sandeep M. Menon,Ralph B. D'Agostino, Sr.,Siyan Xu,Bo Jin, PhD Pdf

Biosimilars have the potential to change the way we think about, identify, and manage health problems. They are already impacting both clinical research and patient care, and this impact will only grow as our understanding and technologies improve. Written by a team of experienced specialists in clinical development, this book discusses various potential drug development strategies, the design and analysis of pharmacokinetics (PK) studies, and the design and analysis of efficacy studies.

Biosimilarity

Sarfaraz K. Niazi
Biosimilarity Book PDF

Author : Sarfaraz K. Niazi
Publisher : CRC Press
Page : 436 pages
File Size : 50,9 Mb
Release : 2018-10-03
Category : Medical
ISBN : 9781498750400

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Biosimilarity by Sarfaraz K. Niazi Pdf

Summary: The focus of this book is on how the U.S. FDA will approve biosimilar drugs, as learned from recent approvals by the FDA. Understanding the limitations of the statutory limits and non-inferiority testing are presented as tools to obviate patient trials and minimize testing of immunogenicity. An in-depth scientific, mathematical and statistical view of the tools required to establish biosimilarity of biological drugs of different complexity -- a must for every developer of biosimilars. Features: First comprehensive analysis based on new guidelines and approval packages of several biosimilars Presents the first approach to challenge FDA in reducing or eliminating any testing in patients. Provides a comprehensive understanding of the U.S. statutory requirements vis-a-vis the regulatory guidelines Provides model CQA and Analytical Similarity testing protocols for cytokines and monoclonal antibodies Allow creation of a fast-to-market pathway to develop biosimilars

Upper Tract Urothelial Carcinoma

Shahrokh F. Shariat,Evanguelos Xylinas
Upper Tract Urothelial Carcinoma Book PDF

Author : Shahrokh F. Shariat,Evanguelos Xylinas
Publisher : Springer
Page : 198 pages
File Size : 42,6 Mb
Release : 2014-09-13
Category : Medical
ISBN : 9781493915019

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Upper Tract Urothelial Carcinoma by Shahrokh F. Shariat,Evanguelos Xylinas Pdf

Upper Tract Urothelial Carcinoma represents the first book of its kind to be dedicated solely to UTUC. It's aim is to improve understanding and eventually care of a disease that is greatly understudied and underappreciated, yet commonly dealt with by many medical and urologic oncologists. The volume features new data regarding genetic susceptibility, gene expression studies and causative factors; contemporary concepts and controversies regarding diagnosis and staging of UTUC; prediction tools and their value in treatment decisions within each disease stage and patient selection and treatment options such as endoscopic management, distal ureterectomy, radical nephroureterectomy and chemotherapy. Up-to-date information regarding boundaries of surgical resection, indication and extent of lymphadenectomy is covered as well as the role of perioperative/neoadjuvant chemotherapy in patients with high-risk UTUC. Upper Tract Urothelial Carcinoma will be of great value to all Urologists, Medical Oncologists and fellows in Urologic Oncology as well as upper level residents in training in Urology and Medical Oncology.

Cancer Care in Low-Resource Areas

National Academies of Sciences, Engineering, and Medicine,Health and Medicine Division,Board on Health Care Services,National Cancer Policy Forum
Cancer Care in Low Resource Areas Book PDF

Author : National Academies of Sciences, Engineering, and Medicine,Health and Medicine Division,Board on Health Care Services,National Cancer Policy Forum
Publisher : National Academies Press
Page : 127 pages
File Size : 45,8 Mb
Release : 2017-11-14
Category : Medical
ISBN : 9780309458023

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Cancer Care in Low-Resource Areas by National Academies of Sciences, Engineering, and Medicine,Health and Medicine Division,Board on Health Care Services,National Cancer Policy Forum Pdf

Though cancer was once considered to be a problem primarily in wealthy nations, low- and middle-income countries now bear a majority share of the global cancer burden, and cancer often surpasses the burden of infectious diseases in these countries. Effective low-cost cancer control options are available for some malignancies, with the World Health Organization estimating that these interventions could facilitate the prevention of approximately one-third of cancer deaths worldwide. Effective cancer treatment approaches are also available and can reduce the morbidity and mortality due to cancer in low-resource areas. But these interventions remain inaccessible for many people in the world, especially those residing in low-resource communities that are characterized by a lack of fundsâ€"on an individual or a societal basisâ€"to cover health infrastructure and care costs. As a result, worse outcomes for patients with cancer are more common in low- and middle-income countries compared with high-income countries. Few guidelines and strategies for cancer control consider the appropriateness and feasibility of interventions in low-resource settings, and this may undermine the effectiveness of care. Recognizing the challenges of providing cancer care in resource constrained settings, the National Academies of Sciences, Engineering, and Medicine developed a two- workshop series examining cancer care in low-resource communities, building on prior work of the National Academies. The first workshop, held in October 2015, focused on cancer prevention and early detection. The second workshop was held in November 2016, and focused on cancer treatment, palliative care, and survivorship care in low-resource areas. This publication summarizes the presentations and discussions of this workshop.