Biologics, Biosimilars, and Biobetters - read free eBook in online reader or directly download on the web page. Select files or add your book in reader. Download and read online ebook Biologics, Biosimilars, and Biobetters write by Iqbal Ramzan. This book was released on 2021-02-03. Biologics, Biosimilars, and Biobetters available in PDF, EPUB and Kindle. 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
Nonclinical Development of Novel Biologics, Biosimilars, Vaccines and Specialty Biologics
Nonclinical Development of Novel Biologics, Biosimilars, Vaccines and Specialty Biologics - read free eBook in online reader or directly download on the web page. Select files or add your book in reader. Download and read online ebook Nonclinical Development of Novel Biologics, Biosimilars, Vaccines and Specialty Biologics write by Lisa M.. Plitnick. This book was released on 2015. Nonclinical Development of Novel Biologics, Biosimilars, Vaccines and Specialty Biologics available in PDF, EPUB and Kindle.
Biosimilars and Interchangeable Biologics
Biosimilars and Interchangeable Biologics - read free eBook in online reader or directly download on the web page. Select files or add your book in reader. Download and read online ebook Biosimilars and Interchangeable Biologics write by Sarfaraz K. Niazi. This book was released on 2018-10-30. Biosimilars and Interchangeable Biologics available in PDF, EPUB and Kindle. 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
Biosimilars - read free eBook in online reader or directly download on the web page. Select files or add your book in reader. Download and read online ebook Biosimilars write by Hiten J. Gutka. This book was released on 2018-12-13. Biosimilars available in PDF, EPUB and Kindle. 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.
Handbook of Biologics & Biosimilars in Dermatology
Handbook of Biologics & Biosimilars in Dermatology - read free eBook in online reader or directly download on the web page. Select files or add your book in reader. Download and read online ebook Handbook of Biologics & Biosimilars in Dermatology write by Manas Chatterjee. This book was released on 2018-08-16. Handbook of Biologics & Biosimilars in Dermatology available in PDF, EPUB and Kindle. A drug is typically manufactured through chemical synthesis, which means that it is made by combining specific chemical ingredients in an ordered process. Biologics are medicines made from living cells through highly complex manufacturing processes and must be handled and administered under carefully monitored conditions. Biologics are used to prevent, treat, diagnose, or cure a variety of diseases including cancer, chronic kidney disease, autoimmune disorders, and infectious diseases. A biosimilar is a biologic that is similar to another biologic drug already that has already been approved. This book is a complete guide to the use of biologics and biosimilars in the treatment of dermatologic disorders. Beginning with an overview of the history and classification of biologics and the concept of biosimilars, the following chapters explain their therapeutic use for different skin conditions. The final sections cover related topics such as cost effectiveness and quality of life with biologic therapy, and the book concludes with discussion on future developments and the use of small molecule treatment. Key points Complete guide to use of biologics and biosimilars in treatment of dermatologic disorders Covers many different skin diseases and conditions Discusses related topics such as cost effectiveness and quality of life Covers future development of small molecule therapy
