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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

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;

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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 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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Drug Product Development for the Back of the Eye

of administration and delivery systems Noninvasive and continuous drug monitoring Regulatory path to drug product development Clinical endpoints for;

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Biosimilar and Interchangeable Biologics

of biosimilar products, and it discusses the utilization of biosimilars and related biological drugs in expanding world markets. This volume also;

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Generic Drug Product Development

Generic Drug Product Development: Specialty Dosage Forms explores the issues related to providing evidence of pharmaceutical equivalence;

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Generic Drug Product Development

Generic Drug Product Development: Specialty Dosage Forms explores the issues related to providing evidence of pharmaceutical equivalence;

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Generic Drug Product Development: Solid Oral Dosage Forms, Second Edition

and regulatory concerns. Generic Drug Product Development: Solid Oral Dosage Forms, Second Edition presents in-depth discussions from more;

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Pharmaceutical Drug Product Development and Process Optimization

systematic development of drug products with predefined objectives to provide enhanced product and process understanding. This volume presents and;

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Biosimilars of Monoclonal Antibodies

Addressing a significant need by describing the science and process involved to develop biosimilars of monoclonal antibody (mAb) drugs;

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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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Topical and Transdermal Drug Delivery

scientists, skin product development experts, and those in the cosmetic and personal care industry with practical knowledge and insight into future;

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Generic Drug Product Development

The assessment of bioequivalence is an important process whereby the bioavailability of a generic drug product is compared with its brand;

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Supercritical Fluid Technology for Drug Product Development

of supercritical fluids to further the development of improved pharmaceutical products-from drug powders for respiratory delivery to drug delivery systems;

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Chemical Engineering in the Pharmaceutical Industry

drug product design and development. The second edition has been greatly expanded and covers a range of topics related to formulation design;

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The Future of Pharmaceutical Product Development and Research

Product Development and Research series deepens our understanding of the product development phase of drug discovery and drug development. Each;

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Career Opportunities In Biotechnology And Drug Development

Offers detailed information on over one hundred careers in such areas as regulatory affairs, product development, information management;

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Real-World Evidence in Drug Development and Evaluation

This book concerns use of real world data (RWD) and real world evidence (RWE) to aid drug development across product cycle. RWD are;

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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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Pediatric Drug Research & the FDA

requires that sponsors conduct pediatric studies for certain products unless the Department of Health and Human Services' (HHS) Food and Drug;

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Bioassay Methods in Natural Product Research and Drug Development

Bioassay Methods in Natural Product Research and Drug Development contains the proceedings from the Phytochemical Society of Europe's;

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Quantitative Evaluation of Safety in Drug Development

clinical trials and observational studies in biopharmaceutical product development. It presents the latest statistical methods for drug safety;

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