Introduction To Biologic And Biosimilar Product Development And Analysis
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Introduction To Biologic And Biosimilar Product Development And Analysis
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Author : Karen Nagel
language : en
Publisher:
Release Date : 2018
Introduction To Biologic And Biosimilar Product Development And Analysis written by Karen Nagel and has been published by this book supported file pdf, txt, epub, kindle and other format this book has been release on 2018 with Biologicals categories.
The purpose of this book is to give a concise introduction to development and analysis of pharmaceutical biologics for those in the pharmaceutical industry who are switching focus from small molecules to biologics processing, analysis, and delivery. In order to maintain a limited focus, Introduction to Biologic and Biosimilar Product Development and Analysis, will deal only with peptides, proteins and monoclonal antibodies.
Introduction To Biologic And Biosimilar Product Development And Analysis
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Author : Karen M. Nagel
language : en
Publisher: Springer
Release Date : 2018-09-27
Introduction To Biologic And Biosimilar Product Development And Analysis written by Karen M. Nagel and has been published by Springer this book supported file pdf, txt, epub, kindle and other format this book has been release on 2018-09-27 with Science categories.
The purpose of this book is to give a concise introduction to development and analysis of pharmaceutical biologics for those in the pharmaceutical industry who are switching focus from small molecules to biologics processing, analysis, and delivery. In order to maintain a limited focus, Introduction to Biologic and Biosimilar Product Development and Analysis, will deal only with peptides, proteins and monoclonal antibodies.
Biosimilars
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Author : Shein-Chung Chow
language : en
Publisher: Chapman & Hall/CRC
Release Date : 2019-10-23
Biosimilars written by Shein-Chung Chow and has been published by Chapman & Hall/CRC this book supported file pdf, txt, epub, kindle and other format this book has been release on 2019-10-23 with Biological products categories.
Written by a top biostatistics researcher, this is the first book entirely devoted to the statistical design and analysis of biosimilarity and interchangeability of biosimilar products. It includes comparability tests of important quality attributes at critical stages of the manufacturing processes of biologic products. The book focuses on the scientific factors and practical issues related to the design and analysis of biosimilar studies. It covers most of the statistical questions encountered in various study designs at different stages of research and development of biological products.
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.
Methodologies for Biosimilar Product Development covers the practical and challenging issues that are commonly encountered during the development, review, and approval of a proposed biosimilar product. These practical and challenging issues include, but are not limited to the mix-up use of interval hypotheses testing (i.e., the use of TOST) and confidence interval approach, a risk/benefit assessment for non-inferiority/similarity margin, PK/PD bridging studies with multiple references, the detection of possible reference product change over time, design and analysis of biosimilar switching studies, the assessment of sensitivity index for assessment of extrapolation across indications without collecting data from those indications not under study, and the feasibility and validation of non-medical switch post-approval. Key Features: 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. This book embraces innovative thinking of design and analysis for biosimilar studies, which are required for review and approval of biosimilar regulatory submissions.
Analytical Similarity Assessment In Biosimilar Product Development
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Author : Shein-Chung Chow
language : en
Publisher: CRC Press
Release Date : 2018-09-03
Analytical Similarity Assessment In Biosimilar Product Development written by Shein-Chung Chow and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2018-09-03 with Mathematics categories.
This book focuses on analytical similarity assessment in biosimilar product development following the FDA’s recommended stepwise approach for obtaining totality-of-the-evidence for approval of biosimilar products. It covers concepts such as the tiered approach for assessment of similarity of critical quality attributes in the manufacturing process of biosimilar products, models/methods like the statistical model for classification of critical quality attributes, equivalence tests for critical quality attributes in Tier 1 and the corresponding sample size requirements, current issues, and recent developments in analytical similarity assessment.
Biosimilar Drug Product Development
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Author : Taylor & Francis Group
language : en
Publisher: CRC Press
Release Date : 2020-07-02
Biosimilar Drug Product Development written by Taylor & Francis Group and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2020-07-02 with categories.
When a biological drug patent expires, alternative biosimilar products are developed. The development of biosimilar products is complicated and involves numerous considerations and steps. The assessment of biosimilarity and interchangeability is also complicated and difficult. Biosimilar Drug Product Development presents current issues for the development of biosimilars and gives detailed reviews of its various stages and contributing factors as well as relevant regulatory pathways and pre- and post-approval issues.
Biologics Biosimilars And Biobetters
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Author : Iqbal Ramzan
language : en
Publisher: John Wiley & Sons
Release Date : 2021-02-03
Biologics Biosimilars And Biobetters written by Iqbal Ramzan 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 2021-02-03 with Medical categories.
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
Biosimilar Drug Product Development
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Author : Laszlo Endrenyi
language : en
Publisher: CRC Press
Release Date : 2017-02-24
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 2017-02-24 with Medical categories.
When a biological drug patent expires, alternative biosimilar products are developed. The development of biosimilar products is complicated and involves numerous considerations and steps. The assessment of biosimilarity and interchangeability is also complicated and difficult. Biosimilar Drug Product Development presents current issues for the development of biosimilars and gives detailed reviews of its various stages and contributing factors as well as relevant regulatory pathways and pre- and post-approval issues.
Biosimilars
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Author : Shein-Chung Chow
language : en
Publisher: CRC Press
Release Date : 2013-07-29
Biosimilars written by Shein-Chung Chow and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2013-07-29 with Mathematics categories.
As many biological products face losing their patents in the next decade, the pharmaceutical industry needs an abbreviated regulatory pathway for approval of biosimilar drug products, which are cost-effective, follow-on/subsequent versions of the innovator's biologic products. But scientific challenges remain due to the complexity of both the manuf
Biopharmaceutical Applied Statistics Symposium
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Author : Karl E. Peace
language : en
Publisher: Springer
Release Date : 2018-09-03
Biopharmaceutical Applied Statistics Symposium written by Karl E. Peace and has been published by Springer this book supported file pdf, txt, epub, kindle and other format this book has been release on 2018-09-03 with Medical categories.
This BASS book Series publishes selected high-quality papers reflecting recent advances in the design and biostatistical analysis of biopharmaceutical experiments – particularly biopharmaceutical clinical trials. The papers were selected from invited presentations at the Biopharmaceutical Applied Statistics Symposium (BASS), which was founded by the first Editor in 1994 and has since become the premier international conference in biopharmaceutical statistics. The primary aims of the BASS are: 1) to raise funding to support graduate students in biostatistics programs, and 2) to provide an opportunity for professionals engaged in pharmaceutical drug research and development to share insights into solving the problems they encounter. The BASS book series is initially divided into three volumes addressing: 1) Design of Clinical Trials; 2) Biostatistical Analysis of Clinical Trials; and 3) Pharmaceutical Applications. This book is the third of the 3-volume book series. The topics covered include: Targeted Learning of Optimal Individualized Treatment Rules under Cost Constraints, Uses of Mixture Normal Distribution in Genomics and Otherwise, Personalized Medicine – Design Considerations, Adaptive Biomarker Subpopulation and Tumor Type Selection in Phase III Oncology Trials, High Dimensional Data in Genomics; Synergy or Additivity - The Importance of Defining the Primary Endpoint, Full Bayesian Adaptive Dose Finding Using Toxicity Probability Interval (TPI), Alpha-recycling for the Analyses of Primary and Secondary Endpoints of Clinical Trials, Expanded Interpretations of Results of Carcinogenicity Studies of Pharmaceuticals, Randomized Clinical Trials for Orphan Drug Development, Mediation Modeling in Randomized Trials with Non-normal Outcome Variables, Statistical Considerations in Using Images in Clinical Trials, Interesting Applications over 30 Years of Consulting, Uncovering Fraud, Misconduct and OtherData Quality Issues in Clinical Trials, Development and Evaluation of High Dimensional Prognostic Models, and Design and Analysis of Biosimilar Studies.