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Hormone antagonists --- 577.171 --- Antagonists, Hormone --- Antihormones --- Chemical inhibitors --- Immunoglobulins --- 577.171 General studies of hormones --- General studies of hormones --- Testing --- Pharmacology. Therapy --- Pathological endocrinology

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The biotechnology/biopharmaceutical sector has tremendously grown which led to the invention of engineered antibodies such as Antibody Drug Conjugates (ADCs), Bispecific T-cell engager (BITES), Dual Variable Domain (DVD) antibodies, and fusion proteins that are currently being used as therapeutic agents for immunology, oncology and other disease conditions. Regulatory agencies have raised the bar for the development and manufacture of antibody-based products, expecting to see the use of Quality by Design (QbD) elements demonstrating an in-depth understanding of product and process based on sound science. Drug delivery systems have become an increasingly important part of the therapy and most biopharmaceuticals for self-administration are being marketed as combination products. A survey of the market indicates that there is a strong need for a new book that will provide “one stop shopping” for the latest information and knowledge of the scientific and engineering advances made over the last few years in the area of biopharmaceutical product development. The new book entitled Development of Biopharmaceutical Drug Device Products is a reference text for scientists and engineers in the biopharmaceutical industry, academia or regulatory agencies. With insightful chapters from experts in the field, this new book reviews first principles, covers recent technological advancements and provides case studies and regulatory strategies relating to the development and manufacture of antibody-based products. It covers topics such as the importance of early preformulation studies during drug discovery to influence molecular selection for development, formulation strategies for new modalities, and the analytical techniques used to characterize them. It also addresses important considerations for later stage development such as the development of robust formulations and processes, including process engineering and modeling of manufacturing unit operations, the design of analytical comparability studies, and characterization of primary containers (pre-filled syringes and vials). Finally, the latter half of the book reviews key considerations to ensure the development and approval of a patient-centered delivery system design. This involves the evolving regulatory framework with perspectives from both the US and EU industry experts, the role of international standards, design control/risk management, human factors and its importance in the product development and regulatory approval process, as well as review of the risk-based approach to bridging between devices used in clinical trials and the to-be-marketed device. Finally, case studies are provided throughout. The typical readership would have biology and/or engineering degrees and would include researchers, scientific leaders, industry specialists and technology developers working in the biopharmaceutical field. .

Pharmaceutical technology. --- Pharmacy. --- Pharmaceutical Sciences/Technology. --- Drug delivery systems. --- Drug development. --- Chemistry --- Medicine --- Drugs --- Materia medica --- Pharmacology --- Pharmaceutical laboratory techniques --- Pharmaceutical laboratory technology --- Technology, Pharmaceutical --- Technology --- Development of drugs --- New drug development --- Pharmacy --- Delivery systems, Drug --- Drug administration technology --- Drug delivery technology --- Pharmaceutical technology --- Development --- Delivery systems --- Biofarmàcia --- Tecnologia farmacèutica --- Immunoglobulines --- Anticossos --- Proteïnes de la sang --- Autoanticossos --- Anticossos monoclonals --- Anticossos policlonals --- Antihormones --- Antitoxines --- Immunofluorescència --- Immunoglobulina A --- Immunoglobulina E --- Immunoglobulina G --- Immunoglobulina M --- Lectines --- Antígens --- Gammaglobulines --- Farmàcia galènica --- Tècnica farmacèutica --- Tècniques farmacèutiques --- Tecnologies farmacèutiques --- Anàlisi de medicaments --- Biotecnologia farmacèutica --- Dispositius d'administració de medicaments --- Síntesi de fàrmacs --- Sistemes d'alliberament de medicaments --- Farmàcia --- Biofarmacèutica --- Biofarmacologia --- Farmacologia --- Equivalència terapèutica dels medicaments

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This book presents a compact overview of the history, evolution and fascinating novel applications of antibodies for the treatment of cancer, leading the reader step by step to the latest advances. Interesting anecdotes, together with self-explanatory and clearly structured figures with a humorous touch, facilitate the reader’s understanding of this complex topic. Clinical cases round out the book, making it a valuable aid for professionals in their everyday practice. The growing importance of the topics covered here was highlighted by the joint award of the 2018 Nobel Prize in Chemistry to Frances H. Arnold (directed evolution of enzymes), George P. Smith (phage display of peptides) and Sir Gregory P. Winter (phage display of antibodies). Furthermore, the 2018 Nobel Prize in Physiology or Medicine was awarded to James P. Allison and Tasuku Honjo for their discovery of cancer therapy by inhibition of negative immune regulation. Many of the antibodies that are now being brought to market target precisely these immune checkpoint modulators. The book addresses a broad readership, ranging from professionals and experts in the field to residents and medical students.

Oncology  . --- Cancer research. --- Oncology. --- Cancer Research. --- Cancer research --- Tumors --- Antineoplastic antibiotics. --- Health. --- Personal health --- Wellness --- Medicine --- Physiology --- Diseases --- Holistic medicine --- Hygiene --- Well-being --- Anticancer antibiotics --- Antitumor antibiotics --- Cytotoxic antibiotics --- Antibiotics --- Antineoplastic agents --- Immunoglobulines --- Immunoteràpia --- Càncer --- Carcinoma --- Carcinosi --- Càncer d'ossos --- Càncer de cap --- Càncer de coll --- Càncer de bufeta --- Càncer de fetge --- Càncer de laringe --- Càncer de mama --- Càncer de pàncrees --- Càncer de pell --- Càncer de pròstata --- Càncer de pulmó --- Càncer de ronyó --- Càncer de tiroide --- Càncer d'ovari --- Càncer gastrointestinal --- Càncer ginecològic --- Càncer en els adolescents --- Càncer en els infants --- Medicaments antineoplàstics --- Melanoma --- Leucèmia --- Sarcoma --- Carcinògens --- Cèl·lules canceroses --- Cirurgia oncològica --- Infermeria oncològica --- Malalts de càncer --- Metàstasi --- Oncologia --- Terapèutica immunològica --- Immunologia clínica --- Terapèutica --- Adjuvants immunològics --- Seroteràpia --- Timosina --- Anticossos --- Proteïnes de la sang --- Autoanticossos --- Anticossos monoclonals --- Anticossos policlonals --- Antihormones --- Antitoxines --- Immunofluorescència --- Immunoglobulina A --- Immunoglobulina E --- Immunoglobulina G --- Immunoglobulina M --- Lectines --- Antígens --- Gammaglobulines