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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

Manufacturing of Biosimilars Section IV: Analytical Similarity Considerations for Biosimilars Section V: Clinical aspects of Biosimilar;

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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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Biosimilar and Interchangeable Biologics

Elements, explores the development and manufacturing of biosimilars and targets challenges surrounding the creation of these products. This;

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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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Biosimilarity

Similarity testing protocols for cytokines and monoclonal antibodies Allow creation of a fast-to-market pathway to develop biosimilars;

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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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Similarity and Compatibility in Fuzzy Set Theory

systems. The assessment of similarity has played an important role in such diverse disciplines such as taxonomy, psychology, and the social;

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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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Natural Product Chemistry at a Glance

Natural products have been a fertile area of chemical investigation for many years, driving the development of both analytical chemistry;

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Deep Data Analytics for New Product Development

for analysts involved in new product development. Readers with an analytical bent or who want to develop analytical expertise would also;

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Deep Data Analytics for New Product Development

for analysts involved in new product development. Readers with an analytical bent or who want to develop analytical expertise would also;

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Analytical Assessment of e-Cigarettes

A volume in the Emerging Issues in Analytical Chemistry series, Analytical Assessment of E-Cigarettes: From Contents to Chemical and;

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Life-Cycle Assessment

Life-Cycle Assessment presents a brief overview of the development of the life-cycle assessment process and develops guidelines and;

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Life-Cycle Assessment

Life-Cycle Assessment presents a brief overview of the development of the life-cycle assessment process and develops guidelines and;

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Social Assessment Manual

A Social Well-Being Account is the product of an assessment of the comparative beneficial and adverse social effects likely to occur as a;

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Social Assessment Manual

A Social Well-Being Account is the product of an assessment of the comparative beneficial and adverse social effects likely to occur as a;

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Biosimilar Clinical Development

Biosimilars have the potential to change the way we think about, identify, and manage health problems. They are already impacting both;

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Biosimilar Clinical Development

Biosimilars have the potential to change the way we think about, identify, and manage health problems. They are already impacting both;

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Pharmaceutical Quality by Design

, analytical development, formulation development, dissolution testing, manufacturing, stability studies, bioequivalence testing, risk and assessment;

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Inhaled Pharmaceutical Product Development Perspectives

Inhaled Pharmaceutical Product Development Perspectives: Challenges and Opportunities describes methods and procedures for;

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Application of Spectral studies in Pharmaceutical Product development

This book compiled with a special emphasis on the application of spectral and analytical data in the development and characterization;

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On the Origin of Products

subsequent development into families of advanced versions. This theory employs a product evolution diagram as an analytical framework to reconstruct;

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Seasonality and Sedentism

broad range of specific analytical techniques of seasonality assessment and show variability and similarity in settlement patterns worldwide;

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Standards, Conformity Assessment and Trade

Assessment, and Trade provides a comprehensive, up-to-date analysis of the link between standards, product testing and certification, and U.S;

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