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Biosimilars

This book provides a comprehensive overview of the biosimilar regulatory framework, the development process and clinical aspects for;

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Biosimilar Drug Product Development

When a biological drug patent expires, alternative biosimilar products are developed. The development of biosimilar products is complicated;

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Biosimilars of Monoclonal Antibodies

, this book covers all aspects of biosimilar development: preclinical, clinical, regulatory, manufacturing. Guides readers through the complex;

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Biosimilar Clinical Development

specialists in clinical development, this book discusses various potential drug development strategies, the design and analysis of pharmacokinetics;

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Biosimilar Clinical Development

specialists in clinical development, this book discusses various potential drug development strategies, the design and analysis of pharmacokinetics;

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Analytical Similarity Assessment in Biosimilar Product Development

This book focuses on analytical similarity assessment in biosimilar product development following the FDA's recommended stepwise approach;

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Analytical Similarity Assessment in Biosimilar Product Development

This book focuses on analytical similarity assessment in biosimilar product development following the FDA's recommended stepwise approach;

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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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Biosimilar and Interchangeable Biologics

overall reduction time in costs and development. Biosimilars and Interchangeable Biologics: From Cell Line to Commercial Launch covers the;

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Biopharmaceutical Applied Statistics Symposium

, Expanded Interpretations of Results of Carcinogenicity Studies of Pharmaceuticals, Randomized Clinical Trials for Orphan Drug Development;

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Biosimilars and Interchangeable Biologics

reduction time in costs and development. Part of a two-volume set that covers varying aspects of biosimilars, Biosimilars and Interchangeable;

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Biosimilars and Interchangeable Biologics

reduction time in costs and development. Part of a two-volume set that covers varying aspects of biosimilars, Biosimilars and Interchangeable;

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Biosimilars and Interchangeable Biologics

reduction time in costs and development. Part of a two-volume set that covers varying aspects of biosimilars, Biosimilars and Interchangeable;

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Rift-lines within european regulatory framework for biosimilars when taking heterogeneity and variation during lifecycle of the reference biologic and the biosimilar into account

Rift-Lines Within European Regulatory Framework for Biosimilars When Taking Heterogeneity and Variation During Lifecycle of the Reference;

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Current Applications of Pharmaceutical Biotechnology

This book offers an authoritative review of biopharmaceuticals and their clinical relevance. Biopharmaceuticals have been showing high;

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Co- and Post-Translational Modifications of Therapeutic Antibodies and Proteins

valuable resource for professionals involved in research and development of biopharmaceutical and biosimilar drugs. This is a highly relevant work;

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Adme And Translational Pharmacokinetics / Pharmacodynamics O

development and compares innovator biologics with biosimilar biologics and small molecules with biologics, giving a lessons-learned perspective;

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Data and Safety Monitoring Committees in Clinical Trials

, Biostatistics, Johns Hopkins Bloomberg School of Public Health where he teaches courses on clinical trials and drug development based on his many years;

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Biomarkers in Clinical Drug Development

Presenting applications in clinical development, pharmacokinetic/ pharmacodynamic modelling and clinical trial simulation, this reference;

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Clinical Supervision and Professional Development of the Substance Abuse Counselor - TIP 52

How This TIP Is Organized - This TIP is divided into three parts: * Clinical Supervision and Professional Development of the Substance;

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Biodegradable Polymers in Clinical Use and Clinical Development

This book focuses on biodegradable polymers that are already in clinical use or under clinical development. Synthetic and natural polymers;

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Clinical Biochemistry and Drug Development

This new volume focuses on clinical biochemistry fundamentals, cell culture techniques, and drug discovery and development concepts. It;

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Continuing Professional Development For Clinical Psychologists

This handbook provides a practical self-help guide to continuing professional development for clinical psychologists. * Takes a 'hands-on;

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Clinical Education in Speech-Language Pathology

professional development. It guides the reader through the clinical education process, from pre--placement preparation to assessment of learning that;

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Clinical Trial Optimization Using R

selection in clinical development, through a series of examples and case studies. It provides the clinical researcher with a powerful evaluation;

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Clinical Trial Optimization Using R

selection in clinical development, through a series of examples and case studies. It provides the clinical researcher with a powerful evaluation;

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