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Principles of Molecular Oncology
At the midpoint of the 20th century, our knowledge of cancer was based on epide- ology and pathology, and treatment consisted of surgery and radiation therapy. At mid-century, Medawar and colleagues initiated the understanding of transplantation immunology, Farber described the first use of an antifolic drug to treat leukemia, and Jacobson and coworkers described the irradiation-protection effect of spleen cells. These observations opened the door to the development of chemotherapy and tra- plantation in the treatment of cancer. Despite the rapid development of these new disciplines, progress was usually based on empiric observations and clinical trials. The rapid advances in molecular biology at the end of the 20th century mark a new era in our knowledge of cancer. Molecular immunology, molecular genetics, mole- lar pharmacology, and the Human Genome Project are in the process of providing a level of understanding of cancer undreamed of in the past. Optimism is based on the firm belief that understanding at the molecular level will lead to better and earlier di- nosis, to new forms of treatment, and, most importantly, eventually to prevention of many types of cancer.
The Oncogenomics Handbook
An integrated overview of cancer drug discovery and development from the bench to the clinic, showing with broad strokes and representative examples the drug development process as a network of linked components leading from the discovered target to the ultimate therapeutic product. Following a systems biology approach, the authors explain genomic databases and how to discover oncological targets from them, how then to advance from the gene and transcript to the level of protein biochemistry, how next to move from the chemical realm to that of the living cell and, ultimately, pursue animal modeling and clinical development. Emerging cancer therapeutics including Ritux an, Erbitux, Gleevec Herceptin, Avastin, ABX-EGF, Velcade, Kepivance, Iressa, Tarceva, and Zevalin are addressed. Highlights include cancer genomics, pharmacogenomics, transcriptomics, gene expression analysis, proteomic and enzymatic cancer profiling technologies, and cellular and animal approaches to cancer target validation.
Twenty Years of G-CSF
Granulocyte colony-stimulating factor (G-CSF or GCSF) is a secreted glycoprotein that stimulates the proliferation and differentiation of granulocyte precursor cells, and induces mobilization of peripheral blood progenitor cells from the bone marrow. Development of recombinant human G-CSF has had a profound impact on the treatment of many diseases, including severe chronic neutropenia and cancer, and has enabled peripheral stem cell transplantation to supplant bone marrow transplantation in the autologous setting. This Milestones in Drug Therapy volume describes the experience of the last 20 years of treatment with recombinant human G-CSF, including the basic science, the use of recombinant human G-CSF in both the oncology and nononcology settings, and the safety and economics of its use. Many of the authors were the original investigators of recombinant human G-CSF and other authors are key researchers who provide their outlook for the next 20 years for use of and research with recombinant human G-CSF.
Pharmacokinetics and Pharmacodynamics of Biotech Drugs
This first ever coverage of the pharmacokinetic and pharmacodynamic characteristics of biopharmaceuticals meets the need for a comprehensive book in this field. It spans all topics from lead identification right up to final-stage clinical trials. Following an introduction to the role of PK and PD in the development of biotech drugs, the book goes on to cover the basics, including the pharmacokinetics of peptides, monoclonal antibodies, antisense oligonucleotides, as well as viral and non-viral gene delivery vectors. The second section discusses such challenges and opportunities as pulmonary delivery of proteins and peptides, and the delivery of oligonucleotides. The final section considers the integration of PK and PD concepts into the biotech drug development plan, taking as case studies the preclinical and clinical drug development of tasidotin, as well as the examples of cetuximab and pegfilgrastim. The result is vital reading for all pharmaceutical researchers.
Clinical Trial Simulations
This edition includes both updates and new uses and issues concerning CTS, along with case studies of how clinical trial simulations are being applied in various therapeutic and application areas. Importantly, the book expands on the utility of CTS for informing decisions during drug development and regulatory review. Each chapter author was selected on the basis of demonstrated expertise in state-of-the-art application of CTS. The target audience for this volume includes researchers and scientists who wish to consider use of simulations in the design, analysis, or regulatory review and guidance of clinical trials. This book does not embrace all aspects of trial design, nor is it intended as a complete recipe for using computers to design trials. Rather, it is an information source that enables the reader to gain understanding of essential background and knowledge for practical applications of simulation for clinical trial design and analysis. It is assumed that the reader has a working understanding of pharmacokinetics and pharmacodynamics, modeling, pharmacometric analyses, and/or the drug development and regulatory processes.
Measuring Immunity
Most of the diseases of modern mankind involve either acute or chronic inflammation. Measuring Immunity integrates the current information available on biomarkers and surrogate assays into a single handbook. It highlights the principles behind various applications, gives a brief summary on how they are conducted and provides detailed and critical analyses of murine models of immunity, clinical trials, and tests to predict utility and benefit. Measuring Immunity is indispensable for scientists and clinicians interested in the clinical applications of modern immunobiology.* Defines which assays of immune function are helpful in the assessment of clinical disorders involving inflammation and immunity* Assesses the dynamics of cellular and soluble factors in the peripheral blood using modern techniques * Includes basic science foundations as well as the approaches currently applied
Genomic Biomarkers for Pharmaceutical Development
Genomic Biomarkers for Pharmaceutical Development: Advancing Personalized Health Care provides an in-depth review of the state of translational science across all stages of pharmaceutical development with a special focus on personalized health care. This book provides a complete picture of biomarker development and validation in a pharmaceutical setting while addressing the inherent challenges of targeting the appropriate indications, biomarker robustness, regulatory hurdles, commercialization and much more. It features case studies devoted to the applications of pharmacogenomics, toxicogenomics, and other genetic technologies as they support drug discovery and development. With chapters wri...
Biologics and Biosimilars
Biologics and Biosimilars: Drug Discovery and Clinical Applications is a systematic integration and evaluation of all aspects of biologics and biosimilars, encompassing research and development, clinical use, global regulation, and more. Biosimilars are biological therapeutic agents designed to imitate a reference biologic with high similarities in structure, efficacy, and safety, but also with potential clinical effective and cost-efficient options for the manufacturers, payers, clinicians, and patients. Most of the top-selling prescription drugs in the current market are biologics, which have revolutionized the treatment strategies and modalities for life-threatening and/or rare diseases. ...
Biosimilars
This book provides a comprehensive overview of the biosimilar regulatory framework, the development process and clinical aspects for 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 of action, the quality of the molecule, published information on the reference product, the current competitive environment, the target market and regulatory guidance, and most importantly, the emerging totality of evidence for the proposed biosimilar during development. For the ease of readers, the book comprises of six sections as follows: Section I: Business, Health Economics and Intellectual Property Landscape for...
Handbook of Therapeutic Antibodies
Dieses Nachschlagewerk zu therapeutischen Antikörpern sucht auch in der komplett überarbeiteten 2. Auflage seinesgleichen und bietet 30 % neue Inhalte zu Entwicklung, Herstellung und therapeutischen Anwendungen dieser Biomoleküle.
