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Author: P. Cornes
Publisher: Karger Medical and Scientific Publishers
ISBN: 1912776227
Category : Medical
Languages : en
Pages : 130
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Book Description
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
Author: P. Cornes
Publisher: Karger Medical and Scientific Publishers
ISBN: 1912776227
Category : Medical
Languages : en
Pages : 130
Get Book
Book Description
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
Author: Paul Cornes
Publisher: Karger Medical and Scientific Publishers
ISBN: 1910797677
Category : Medical
Languages : en
Pages : 72
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Book Description
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?
Author: A. Hackshaw
Publisher: Karger Medical and Scientific Publishers
ISBN: 191277674X
Category : Medical
Languages : en
Pages : 120
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Book Description
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.
Author: John A. Hird
Publisher: Policy Press
ISBN: 1447333829
Category : Political Science
Languages : en
Pages : 384
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Book Description
Policy Analysis in the United States gathers a group of original contributions by scholars and leading practitioners of public policy analysis. Originating in the United States, the field of public policy analysis has affected nations around the world and been enhanced by contributions of scholars and practitioners in other regions, but it remains most highly developed and practiced in education and government here. This volume explores the nature of policy analysis in different sectors and at different levels of government, as well as by nongovernmental actors, such as unions, businesses, NGOs, and the media.
Author: Kerry B. Barker
Publisher: CRC Press
ISBN: 1482231700
Category : Mathematics
Languages : en
Pages : 269
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Book Description
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.
Author: Iqbal Ramzan
Publisher: John Wiley & Sons
ISBN: 1119564654
Category : Medical
Languages : en
Pages : 328
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Book Description
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
Author: Jack Uetrecht
Publisher: Springer Science & Business Media
ISBN: 9783642006630
Category : Medical
Languages : en
Pages : 556
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Book Description
This book provides the current state of knowledge of basic mechanisms of adverse drug reactions (ADRs). The main focus is on idiosyncratic drug reactions because they are the most difficult to deal with. It starts with a general description of the major targets for ADRs followed by a description of what are presently believed to be mediators and biochemical pathways involved in idiosyncratic drug reactions. There is also a description of several examples of ADRs that serve to illustrate specific aspects of ADR mechanisms. Eventually the book shows that ultimately better methods are needed to predict which drug candidates are likely to cause ADRs and which patients are at increased risk. But at present research seems to be far from this goal.
Author: Paul S. Yamauchi
Publisher: Springer
ISBN: 3319668846
Category : Medical
Languages : en
Pages : 574
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Book Description
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.
Author: Marco Weert
Publisher: Springer Science & Business Media
ISBN: 0387758410
Category : Medical
Languages : en
Pages : 266
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Book Description
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.
Author: John Marshall
Publisher: Ideapress Publishing
ISBN: 9781646870486
Category : Biography & Autobiography
Languages : en
Pages :
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Book Description
A surprisingly open memoir co-authored by the married duo of a world class oncologist and a cancer survivor about love, pain, hope, strength and resilience while navigating the overwhelming breast cancer advocacy movement. Off Our Chests recounts the story of Liza and John's experience with her diagnosis and treatment. Written in alternating voices, Liza details her treatment, the complex decisions she had to make throughout her course of chemotherapy and radiation, including clinical trial participation and an elective double mastectomy, the added complexity of being treated at the cancer center of which John was the chief of hematology and oncology, and the emotional impact of knowing she may die as a young woman with young children. John, who lost his own mother to cancer at the age of 13, provides an inside look into the world of cancer care and research, but also the perspective of someone who understands the medicine but who was unprepared for assuming the role of caregiver and worried husband. John adds insights into his world of running the clinical operations of the cancer center where Liza would receive her care, commentary on the breast cancer machine, the need for clinical research, the high cost of cancer care, and an easy to understand explanation of the clinical and scientific background of oncology. While they both felt that they were already expert commentators on their own "Cancer Channel" during the course of Liza's illness, they both came to realize how little understanding they truly had of what a cancer diagnosis does to the patient, caregivers, children, family members, and friends. Liza and John share their most intimate thoughts, including many that were previously unsaid--even between the two of them. Both gain an understanding of the other's life, a deeper appreciation of what it means to be a cancer patient, and of the emotional strains of being an oncologist where so many of the patients die on their watch.
