Biosimilar Clinical Development Scientific Considerations And New Methodologies
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Biosimilar Clinical Development Scientific Considerations And New Methodologies
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Author : Kerry B. Barker
language : en
Publisher: CRC Press
Release Date : 2016-11-25
Biosimilar Clinical Development Scientific Considerations And New Methodologies written by Kerry B. Barker and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2016-11-25 with Mathematics categories.
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.
Clinical And Statistical Considerations In Biosimilar Studies
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Author : Kerry B. Barker
language : en
Publisher: Chapman and Hall/CRC
Release Date : 2016-06-01
Clinical And Statistical Considerations In Biosimilar Studies written by Kerry B. Barker and has been published by Chapman and Hall/CRC this book supported file pdf, txt, epub, kindle and other format this book has been release on 2016-06-01 with Mathematics categories.
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.
Biosimilars Of Monoclonal Antibodies
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Author : Cheng Liu
language : en
Publisher: John Wiley & Sons
Release Date : 2016-12-19
Biosimilars Of Monoclonal Antibodies written by Cheng Liu and has been published by John Wiley & Sons this book supported file pdf, txt, epub, kindle and other format this book has been release on 2016-12-19 with Medical categories.
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
Biosimilars
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Author : Hiten J. Gutka
language : en
Publisher: Springer
Release Date : 2018-12-13
Biosimilars written by Hiten J. Gutka and has been published by Springer this book supported file pdf, txt, epub, kindle and other format this book has been release on 2018-12-13 with Medical categories.
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.
Methodologies In Biosimilar Product Development
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Author : Sang Joon Lee
language : en
Publisher: CRC Press
Release Date : 2021-09-30
Methodologies In Biosimilar Product Development written by Sang Joon Lee and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2021-09-30 with Mathematics categories.
Reviews withdrawn draft guidance on analytical similarity assessment. Evaluates various methods for analytical similarity evaluation based on FDA’s current guidelines. Provides a general approach for the use of n-of-1 trial design for assessment of interchangeability. Discusses the feasibility and validity of the non-medical switch studies. Provides innovative thinking for detection of possible reference product change over time.
Biosimilar Clinical Development Scientific Considerations And New Methodologies
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Author : Kerry B. Barker
language : en
Publisher: CRC Press
Release Date : 2016-11-25
Biosimilar Clinical Development Scientific Considerations And New Methodologies written by Kerry B. Barker and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2016-11-25 with Mathematics categories.
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.
Biosimilar Drug Product Development
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Author : Laszlo Endrenyi
language : en
Publisher: CRC Press
Release Date : 2017
Biosimilar Drug Product Development written by Laszlo Endrenyi and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2017 with Drug approval categories.
Cover -- Half Title -- Title Page -- Copyright Page -- Contents -- Preface -- Contributors -- Chapter 1 Introduction: Scientific Factors in Biosimilar Product Development -- Chapter 2 Analytical Characterization: Structural Assessment of Biosimilarity -- Chapter 3 Analytical Similarity Assessment -- Chapter 4 Characterization of Biosimilar Biologics: The Link between Structure and Functions -- Chapter 5 Manufacturing and Process Control Issues: Quality Development of Biosimilar Medicinal Products -- Chapter 6 Nonclinical Studies for Biosimilars -- Chapter 7 The Clinical Development of Biosimilar Drugs -- Chapter 8 Statistical Methods for Assessing Biosimilarity -- Chapter 9 Extrapolation of Indications for Biosimilars: Opportunity for Developers and Challenges for Regulators -- Chapter 10 Interchangeability, Switchability, and Substitution of Biosimilar Products -- Chapter 11 Design and Analysis of Studies for Assessing Interchangeability -- Chapter 12 The Role of the Immunogenicity Evaluation for Biosimilars -- Chapter 13 Pharmacovigilance of Biosimilars -- Chapter 14 Patent Exclusivities Affecting Biosimilars in the United States, Canada, and Europe -- Chapter 15 Biosimilars in the EU: Regulatory Guidelines -- Chapter 16 Biosimilars and Biologics: The Prospects for Competition -- Chapter 17 Plant-Based Production of Biosimilar Drug Products -- Index
Quantitative Methods For Hiv Aids Research
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Author : Cliburn Chan
language : en
Publisher: CRC Press
Release Date : 2017-08-07
Quantitative Methods For Hiv Aids Research written by Cliburn Chan and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2017-08-07 with Mathematics categories.
Quantitative Methods in HIV/AIDS Research provides a comprehensive discussion of modern statistical approaches for the analysis of HIV/AIDS data. The first section focuses on statistical issues in clinical trials and epidemiology that are unique to or particularly challenging in HIV/AIDS research; the second section focuses on the analysis of laboratory data used for immune monitoring, biomarker discovery and vaccine development; the final section focuses on statistical issues in the mathematical modeling of HIV/AIDS pathogenesis, treatment and epidemiology. This book brings together a broad perspective of new quantitative methods in HIV/AIDS research, contributed by statisticians and mathematicians immersed in HIV research, many of whom are current or previous leaders of CFAR quantitative cores. It is the editors’ hope that the work will inspire more statisticians, mathematicians and computer scientists to collaborate and contribute to the interdisciplinary challenges of understanding and addressing the AIDS pandemic.
Applied Surrogate Endpoint Evaluation Methods With Sas And R
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Author : Ariel Alonso
language : en
Publisher: CRC Press
Release Date : 2016-11-30
Applied Surrogate Endpoint Evaluation Methods With Sas And R written by Ariel Alonso and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2016-11-30 with Mathematics categories.
An important factor that affects the duration, complexity and cost of a clinical trial is the endpoint used to study the treatment’s efficacy. When a true endpoint is difficult to use because of such factors as long follow-up times or prohibitive cost, it is sometimes possible to use a surrogate endpoint that can be measured in a more convenient or cost-effective way. This book focuses on the use of surrogate endpoint evaluation methods in practice, using SAS and R.
Statistical Topics In Health Economics And Outcomes Research
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Author : Demissie Alemayehu, PhD
language : en
Publisher: CRC Press
Release Date : 2017-11-22
Statistical Topics In Health Economics And Outcomes Research written by Demissie Alemayehu, PhD and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2017-11-22 with Mathematics categories.
With ever-rising healthcare costs, evidence generation through Health Economics and Outcomes Research (HEOR) plays an increasingly important role in decision-making about the allocation of resources. Accordingly, it is now customary for health technology assessment and reimbursement agencies to request for HEOR evidence, in addition to data from clinical trials, to inform decisions about patient access to new treatment options. While there is a great deal of literature on HEOR, there is a need for a volume that presents a coherent and unified review of the major issues that arise in application, especially from a statistical perspective. Statistical Topics in Health Economics and Outcomes Research fulfils that need by presenting an overview of the key analytical issues and best practice. Special attention is paid to key assumptions and other salient features of statistical methods customarily used in the area, and appropriate and relatively comprehensive references are made to emerging trends. The content of the book is purposefully designed to be accessible to readers with basic quantitative backgrounds, while providing an in-depth coverage of relatively complex statistical issues. The book will make a very useful reference for researchers in the pharmaceutical industry, academia, and research institutions involved with HEOR studies. The targeted readers may include statisticians, data scientists, epidemiologists, outcomes researchers, health economists, and healthcare policy and decision-makers.