biosimilars and interchangeable biologics strategic elements

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Biosimilars And Interchangeable Biologics

Author : Sarfaraz K. Niazi
ISBN : 9781498743488
Genre : Medical
File Size : 66. 46 MB
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What’s the Deal with Biosimilars? Biosimilars are gaining momentum as new protein therapeutic candidates that can help fill a vital need in the healthcare industry. The biological drugs are produced by recombinant DNA technology that allows for large-scale production and an overall reduction time in costs and development. Part of a two-volume set that covers varying aspects of biosimilars, Biosimilars and Interchangeable Biologics: Strategic Elements explores the strategic planning side of biosimilar drugs and targets issues surrounding biosimilars that are linked to legal matters. This includes principal patents and intellectual property, regulatory pathways, and concerns about affordability on a global scale. It addresses the complexity of biosimilar products, and it discusses the utilization of biosimilars and related biological drugs in expanding world markets. Of specific interest to practitioners, researchers, and scientists in the biopharmaceutical industry, this volume examines the science, technology, finance, legality, ethics, and politics of biosimilar drugs. It considers strategic planning elements that include an overall understanding of the history and the current status of the art and science of biosimilars, and it provides detailed descriptions of the legal, regulatory, and commercial characteristics. The book also presents a global strategy on how to build, take to market, and manage the next generation of biosimilars throughout their life cycle.

Biosimilars And Interchangeable Biologics

Author : Sarfaraz K. Niazi
ISBN : 9781498743501
Genre : Medical
File Size : 84. 82 MB
Format : PDF, Mobi
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What’s the Deal with Biosimilars? Biosimilars are gaining momentum as new protein therapeutic candidates that can help fill a vital need in the healthcare industry. The biological drugs are produced by recombinant DNA technology that allows for large-scale production and an overall reduction time in costs and development. Part of a two-volume set that covers varying aspects of biosimilars, Biosimilars and Interchangeable Biologics: Tactical Elements explores the development and manufacturing of biosimilars and targets challenges surrounding the creation of these products. This includes manufacturing, production costs, and intellectual property barriers, particularly in regulated markets (regulatory agencies are still in the process of developing guidelines). It addresses the complexity of biological drugs, and it discusses specific structural elements vital to the functionality, immunogenicity, and safety of biosimilar products. Of specific interest to practitioners, researchers, and scientists in the biopharmaceutical industry, this volume provides an overall understanding of the hurdles, difficulties, and practicalities of developing a strong plan. It introduces a step-by-step approach for creating a strategy that helps develop and manufacture a biosimilar product while reducing overall production costs and meeting the requirements of biosimilarity based on analytical and functional, pharmacokinetic, pharmacodynamic (where applicable), and nonclinical toxicology or toxicokinetic similarity (where appropriate) while remaining competitive in the market.

Biosimilar And Interchangeable Biologics

Author : Sarfaraz K. Niazi
ISBN : 1482298910
Genre : Medical
File Size : 75. 69 MB
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The field of biosimilar drugs is one of the hottest subjects in the filed of new drug development, with scores of companies offering seminar and training programs for prospective manufacturers and stakeholders. This book is a modern comprehensive overview of the entire biosimilar manufacturing and distribution process, covering concepts introduced by the FDA, litigation strategies, analytical methods, pharmokinetic studies, and the future and current status of biosimilar product approvals.

Biosimilar Clinical Development Scientific Considerations And New Methodologies

Author : Kerry B. Barker
ISBN : 9781482231700
Genre : Mathematics
File Size : 61. 53 MB
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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.

Biologics And Biosimilars

Author : Judith A. Johnson
ISBN : OCLC:958376561
Genre : Biologicals
File Size : 60. 8 MB
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Biosimilarity

Author : Sarfaraz K. Niazi
ISBN : 9781315351377
Genre : Medical
File Size : 75. 9 MB
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The focus of this book is on how the US FDA will approve biosimilar drugs. The European scene is well developed with specific guidelines that are already in place. However, these guidelines do not apply to the thinking of the FDA in approving these products. The FDA is quite different from other regulatory agencies. With the US providing more than 50% of the worldwide market for these products, every serious manufacturer of biosimilar biological drugs should be targeting US approval of their products. Thus, this book is strictly on FDA approval strategy.

Necessary Conversations

Author : Gerald Kaufman
ISBN : 9781680991840
Genre : Family & Relationships
File Size : 35. 60 MB
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In this timely book, long-time family counselors, Gerald and Marlene Kaufman, urge aging people, their adult children, family members, and other caretakers to talk directly with each other about the decisions that lie ahead as they age. "Do it before a crisis hits," say the Kaufmans. "A good time to start is when the parents retire." Necessary Conversations focuses on four primary areas: Parents' finances Parents' medical care Parents' living arrangements When to stop driving This honest and resourceful guide for aging adults and their family members includes helpful suggestions for starting these conversations and overcoming confrontation.

Handbook Of Pharmaceutical Manufacturing Formulations Second Edition

Author : Sarfaraz K. Niazi
ISBN : 9781420081176
Genre : Medical
File Size : 34. 97 MB
Format : PDF
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The largest category of pharmaceutical formulations, comprising almost two-thirds of all dosage forms, compressed solids present some of the greatest challenges to formulation scientists. The first volume, Compressed Solid Products, tackles these challenges head on. Highlights from Compressed Solid Products, Volume One include: formulations for more than 200 of the most widely used drugs for all types of release profiles, offering formulators a rare opportunity to start with an optimal composition the essentials of what you need to be aware of when establishing a manufacturing process based on the formulations presented identification and inclusion of the most popular prescription products, a critical list for the selection of products

25days

Author : Drew Logan
ISBN : 9781501162992
Genre : Health & Fitness
File Size : 90. 16 MB
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Celebrity trainer and cast member of NBC’s Strong, Drew Logan shows us how to rewrite our neurological patterns and break the habits that prevent us from losing weight and living a healthy life. Celebrity trainer and cast member of NBC’s Strong, Drew Logan knows firsthand how the brain affects our ability to perform and function at our best. After dying three times in three hours—becoming the world’s only known medical case to survive three sudden cardiac arrests—he lost his short-term memory. He could no longer follow the complicated diet and fitness regimens he’d used on himself and his clients. He needed to create something simpler. He was shocked to discover that the resulting program was even more effective than his complicated regime of the past. In 25Days, Drew outlines a unique, multifaceted approach that helps you rewrite your neurological patterning—what lies underneath those pesky habits that get in our way over and over again—so that the brain’s neural pathways, biochemistry, and hormones work together effectively, seamlessly, and efficiently. Included in the book are the 25 Days Grading System, Diet, and Workout Plan, as well as tools that will alert and assist readers throughout the book. 25Days is “the ultimate tool for fitness” (Jesse L. Martin, actor) and one of the easiest—and most effective—diets to follow. Drew will show you that all you need is to adjust your diet and retrain your brain to be in peak shape and “change your life in ways you never dreamed” (Rick Cosnett, actor).

Handbook Of Bioequivalence Testing

Author : Sarfaraz K. Niazi
ISBN : 0849383595
Genre : Medical
File Size : 35. 67 MB
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As the generic pharmaceutical industry continues to grow and thrive, so does the need to conduct efficient and successful bioequivalence studies. In recent years, there have been significant changes to the statistical models for evaluating bioequivalence, and advances in the analytical technology used to detect drug and metabolite levels have made bioequivalence testing more difficult to conduct and summarize. The Handbook of Bioequivalence Testing offers a complete description of every aspect of bioequivalence testing. Features: Describes the current analytical methods used in bioequivalence testing, as well as their respective strengths and limitations Discusses worldwide regulatory requirements for filing for approval of generic drugs Covers GLP, GCP, and 21 CFR compliance requirements for qualifying studies for regulatory submission and facility certification Includes actual examples of reports approved by regulatory authorities to illustrate various scientific, regulatory, and formatting aspects Provides a list of vendors for the software used to analyze bioequivalence studies and recommendations Explains how to apply for a waiver, how to secure regulatory approval of reports, and how to obtain regulatory certification of facilities conducting bioequivalence studies

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