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Follow-On Biologics

A biologic is a preparation, such as a drug or a vaccine, that is made from living organisms. A follow-on biologic, or biosimilar;

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Nonclinical Development of Novel Biologics, Biosimilars, Vaccines and Specialty Biologics

assessment programs for novel biopharmaceuticals and vaccines, as well as follow-on biologics or "biosimilars"A multi-authored book with;

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Biologics in General Medicine

dermatology and neurology is described in detail and summarized in treatment algorithms. Shorter sections on biologic biotechnology as well as safety;

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Infections Related to Biologics An Issue of Infectious Disease Clinics of North America

, hematologic malignancies, solid tumors, and other conditions; there is a lack of guidance in the literature on how to address their infectious risks;

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FDA Regulatory Affairs

updates to the FDA Safety and Innovation Act (FDASIA), incorporating pediatric guidelines and follow-on biologics regulations from the 2012;

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Biologics, A History Of Agents Made From Living Organisms In

The use of biologics - drugs made from living organisms - has raised specific scientific, industrial;...

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Handbook of Biologics & Biosimilars in Dermatology

disorders. Beginning with an overview of the history and classification of biologics and the concept of biosimilars, the following chapters;

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Adme And Translational Pharmacokinetics / Pharmacodynamics O

With an emphasis on the fundamental and practical aspects of ADME for therapeutic proteins, this book helps readers strategize, plan and;

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Biologics, A History of Agents Made From Living Organisms in the Twentieth Century

The use of biologics - drugs made from living organisms - has raised specific scientific, industrial;...

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Novel Approaches and Strategies for Biologics, Vaccines and Cancer Therapies

challenges involved with the development of novel formulations of biologics, vaccines and cancer therapy. This thorough reference on the latest;

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Drug-Drug Interactions for Therapeutic Biologics

focuses on the theoretical and practical aspects of DDIs assessments for therapeutic biologics in drug development. The book addresses the complex;

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Biologics in Otolaryngology, An Issue of Otolaryngologic Clinics of North America

This issue of Otolaryngologic Clinics, guest edited by Drs. Sarah K. Wise, Ashkan Monfared, and ;...

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Biologics, Biosimilars, and Biobetters

equivalence, efficacy, safety, and risks of biosimilars with physicians, health practitioners, and patients about Guides regulators on pragmatic;

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Biologics in Orthopaedic Surgery

clinical setting, providing guidance on using recent transformative discoveries in real-world practice. Covers applications;

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Biosimilars

pathway for approval of biosimilar drug products, which are cost-effective, follow-on/subsequent versions of the innovator's biologic products;

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Biosimilars

pathway for approval of biosimilar drug products, which are cost-effective, follow-on/subsequent versions of the innovator's biologic products;

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Lyophilized Biologics and Vaccines

lyophilized biologics or vaccine product, based on diverse modalities, ranging from antibodies (e.g., monoclonal, fused), complex biologics (e.g;

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Life Sciences Industry

the most basic as well advanced issues on biological products for successfully managing a life sciences industry. It elucidates the life cycle;

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Safety of Biologics Therapy

This long overdue title provides a comprehensive, up-to-date, state-of-the art review of approved bi;...

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Progress in Medical Research

conditions that a telehealth service must meet to be covered and paid for under Medicare Part B. The second chapter focuses on the background and key;

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Drug Efficacy, Safety, and Biologics Discovery

Drug Efficacy, Safety, and Biologics Discovery: Emerging Technologies and Tools covers key emerging;...

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Biosimilar and Interchangeable Biologics

principal patents and intellectual property, regulatory pathways, and concerns about affordability on a global scale. It addresses the complexity;

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Continuous Manufacturing for the Modernization of Pharmaceutical Production

On July 30-31, 2018, the National Academies of Sciences, Engineering, and Medicine held a workshop titled Continuous Manufacturing for the;

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Biologics for the Treatment of Rheumatoid Arthritis

This book provides a comprehensive overview of the available biologic therapies whilst comparing t;...

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