Fast Facts Biosimilars In Hematology And Oncology

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Fast Facts: Biosimilars in Hematology and Oncology

Author : P. Cornes
Publisher : Karger Medical and Scientific Publishers
ISBN 13 : 1912776227
Total Pages : 130 pages
Book Rating : 4.9/5 (127 download)

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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

Fast Facts: Biosimilars

Author : Paul Cornes
Publisher : Karger Medical and Scientific Publishers
ISBN 13 : 1910797677
Total Pages : 72 pages
Book Rating : 4.9/5 (17 download)

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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?

Fast Facts: Clinical Trials in Oncology

Author : A. Hackshaw
Publisher : Karger Medical and Scientific Publishers
ISBN 13 : 191277674X
Total Pages : 120 pages
Book Rating : 4.9/5 (127 download)

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Book Synopsis Fast Facts: Clinical Trials in Oncology by : A. Hackshaw

Download or read book Fast Facts: Clinical Trials in Oncology written by A. Hackshaw and published by Karger Medical and Scientific Publishers. This book was released on 2020-12-18 with total page 120 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

Biologics, Biosimilars, and Biobetters

Author : Iqbal Ramzan
Publisher : John Wiley & Sons
ISBN 13 : 1119564654
Total Pages : 328 pages
Book Rating : 4.1/5 (195 download)

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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

Safety of Biologics Therapy

Author : Brian A. Baldo
Publisher : Springer
ISBN 13 : 3319304720
Total Pages : 610 pages
Book Rating : 4.3/5 (193 download)

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Book Synopsis Safety of Biologics Therapy by : Brian A. Baldo

Download or read book Safety of Biologics Therapy written by Brian A. Baldo and published by Springer. This book was released on 2016-08-12 with total page 610 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

Biosimilar Clinical Development: Scientific Considerations and New Methodologies

Author : Kerry B. Barker
Publisher : CRC Press
ISBN 13 : 1482231700
Total Pages : 269 pages
Book Rating : 4.4/5 (822 download)

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Book Synopsis Biosimilar Clinical Development: Scientific Considerations and New Methodologies by : Kerry B. Barker

Download or read book Biosimilar Clinical Development: Scientific Considerations and New Methodologies written by Kerry B. Barker and published by CRC Press. This book was released on 2016-11-25 with total page 269 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

Adverse Drug Reactions

Author : Jack Uetrecht
Publisher : Springer Science & Business Media
ISBN 13 : 3642006639
Total Pages : 552 pages
Book Rating : 4.6/5 (42 download)

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Book Synopsis Adverse Drug Reactions by : Jack Uetrecht

Download or read book Adverse Drug Reactions written by Jack Uetrecht and published by Springer Science & Business Media. This book was released on 2009-12-18 with total page 552 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

Off Our Chests - A Candid Tour Through the World of Cancer

Author : John Marshall
Publisher : Ideapress Publishing
ISBN 13 : 9781646870486
Total Pages : pages
Book Rating : 4.8/5 (74 download)

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Book Synopsis Off Our Chests - A Candid Tour Through the World of Cancer by : John Marshall

Download or read book Off Our Chests - A Candid Tour Through the World of Cancer written by John Marshall and published by Ideapress Publishing. This book was released on 2021-05-04 with total page pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

Immunogenicity of Biopharmaceuticals

Author : Marco Weert
Publisher : Springer Science & Business Media
ISBN 13 : 0387758410
Total Pages : 269 pages
Book Rating : 4.3/5 (877 download)

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Book Synopsis Immunogenicity of Biopharmaceuticals by : Marco Weert

Download or read book Immunogenicity of Biopharmaceuticals written by Marco Weert and published by Springer Science & Business Media. This book was released on 2008-02-06 with total page 269 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

Biologic and Systemic Agents in Dermatology

Author : Paul S. Yamauchi
Publisher : Springer
ISBN 13 : 3319668846
Total Pages : 574 pages
Book Rating : 4.3/5 (196 download)

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Book Synopsis Biologic and Systemic Agents in Dermatology by : Paul S. Yamauchi

Download or read book Biologic and Systemic Agents in Dermatology written by Paul S. Yamauchi and published by Springer. This book was released on 2018-01-02 with total page 574 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

The Business of Healthcare Innovation

Author : Lawton R. Burns
Publisher : Cambridge University Press
ISBN 13 : 9780521838986
Total Pages : 400 pages
Book Rating : 4.8/5 (389 download)

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Book Synopsis The Business of Healthcare Innovation by : Lawton R. Burns

Download or read book The Business of Healthcare Innovation written by Lawton R. Burns and published by Cambridge University Press. This book was released on 2005-08-25 with total page 400 pages. Available in PDF, EPUB and Kindle. Book excerpt: The first wide-ranging analysis of business trends in the manufacturing segment of the health care industry.

Policy Analysis in the United States

Author : John A. Hird
Publisher : Policy Press
ISBN 13 : 1447333829
Total Pages : 384 pages
Book Rating : 4.4/5 (473 download)

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Book Synopsis Policy Analysis in the United States by : John A. Hird

Download or read book Policy Analysis in the United States written by John A. Hird and published by Policy Press. This book was released on 2018-02-21 with total page 384 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

Diagnosing and Treating Adult Cancers and Associated Impairments

Author : National Academies Of Sciences Engineeri
Publisher : National Academies Press
ISBN 13 : 9780309684002
Total Pages : pages
Book Rating : 4.6/5 (84 download)

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Book Synopsis Diagnosing and Treating Adult Cancers and Associated Impairments by : National Academies Of Sciences Engineeri

Download or read book Diagnosing and Treating Adult Cancers and Associated Impairments written by National Academies Of Sciences Engineeri and published by National Academies Press. This book was released on 2021-11-10 with total page pages. Available in PDF, EPUB and Kindle. Book excerpt: Cancer is the second leading cause of death among adults in the United States after heart disease. However, improvements in cancer treatment and earlier detection are leading to growing numbers of cancer survivors. As the number of cancer survivors grows, there is increased interest in how cancer and its treatments may affect a person's ability to work, whether the person has maintained employment throughout the treatment or is returning to work at a previous, current, or new place of employment. Cancer-related impairments and resulting functional limitations may or may not lead to disability as defined by the U.S. Social Security Administration (SSA), however, adults surviving cancer who are unable to work because of cancer-related impairments and functional limitations may apply for disability benefits from SSA. At the request of SSA, Diagnosing and Treating Adult Cancers and Associated Impairments provides background information on breast cancer, lung cancer, and selected other cancers to assist SSA in its review of the listing of impairments for disability assessments. This report addresses several specific topics, including determining the latest standards of care as well as new technologies for understanding disease processes, treatment modalities, and the effect of cancer on a person's health and functioning, in order to inform SSA's evaluation of disability claims for adults with cancer.

Upper Tract Urothelial Carcinoma

Author : Shahrokh F. Shariat
Publisher : Springer
ISBN 13 : 1493915010
Total Pages : 206 pages
Book Rating : 4.4/5 (939 download)

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Book Synopsis Upper Tract Urothelial Carcinoma by : Shahrokh F. Shariat

Download or read book Upper Tract Urothelial Carcinoma written by Shahrokh F. Shariat and published by Springer. This book was released on 2014-09-13 with total page 206 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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

Author : National Academies of Sciences, Engineering, and Medicine
Publisher : National Academies Press
ISBN 13 : 0309458021
Total Pages : 127 pages
Book Rating : 4.3/5 (94 download)

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Book Synopsis Cancer Care in Low-Resource Areas by : National Academies of Sciences, Engineering, and Medicine

Download or read book Cancer Care in Low-Resource Areas written by National Academies of Sciences, Engineering, and Medicine and published by National Academies Press. This book was released on 2017-11-14 with total page 127 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

The Selection and Use of Essential Medicines

Author : WHO Expert Committee on the Selection and Use of Essential Medicines
Publisher : WHO
ISBN 13 :
Total Pages : 144 pages
Book Rating : 4.3/5 ( download)

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Book Synopsis The Selection and Use of Essential Medicines by : WHO Expert Committee on the Selection and Use of Essential Medicines

Download or read book The Selection and Use of Essential Medicines written by WHO Expert Committee on the Selection and Use of Essential Medicines and published by WHO. This book was released on 2004 with total page 144 pages. Available in PDF, EPUB and Kindle. Book excerpt: This report presents the recommendations of the WHO Expert Committee responsible for updating the WHO Model List of Essential Medicines. The first part contains a progress report on the new procedures for updating the Model List and the development of the WHO Essential Medicines Library. It continues with a section on changes made in revising the Model List followed by a review of some sections such as hypertensive medicines and fast track procedures for deleting items. Annexes include the 13th version of the Model List and items on the list sorted according to their 5-level Anatomical Therapeutic Chemical classification codes.

Biosimilarity

Author : Sarfaraz K. Niazi
Publisher : CRC Press
ISBN 13 : 1498750400
Total Pages : 436 pages
Book Rating : 4.4/5 (987 download)

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Book Synopsis Biosimilarity by : Sarfaraz K. Niazi

Download or read book Biosimilarity written by Sarfaraz K. Niazi and published by CRC Press. This book was released on 2018-10-03 with total page 436 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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