MaryAnn Foote - Böcker

Leading oncologists, hematologists, and nephrologists comprehensively review the role of HGFs in clinical practice, explain the molecular basis of their effects, and consider potential future developments. The authors focus on the use of HGFs in oncology, describing their cutting-edge application to patients with lung cancer, Hodgkin's and nonhodgkin's lymphoma, breast cancer, chronic lymphocytic leukemia, AIDS-related malignancies, myelodysplastic syndromes, and aplastic anemias. Among the HGFs described are granulocyte colony-stimulating factor, erythropoietc factors, thrombopoietic factors, and stem cell factor and its receptor, C-kit. To complete their survey, the contributors also consider the safety and economic implications of HGFs and the future potential for HGF antagonists in oncology.

Leading oncologists, hematologists, and nephrologists comprehensively review the role of HGFs in clinical practice, explain the molecular basis of their effects, and consider potential future developments. The authors focus on the use of HGFs in oncology, describing their cutting-edge application to patients with lung cancer, Hodgkin's and nonhodgkin's lymphoma, breast cancer, chronic lymphocytic leukemia, AIDS-related malignancies, myelodysplastic syndromes, and aplastic anemias. Among the HGFs described are granulocyte colony-stimulating factor, erythropoietc factors, thrombopoietic factors, and stem cell factor and its receptor, C-kit. To complete their survey, the contributors also consider the safety and economic implications of HGFs and the future potential for HGF antagonists in oncology.

Drawing on years of significant scientific advances and clinical developments, the editors of POMO III have thoroughly updated the highly praised first and second editions and added new chapters to reflect the knowledge emerging from research on genomics, proteomics, chemoprevention strategies, new molecular targets, therapeutic monoclonal antibodies, and innovative cytotoxic and cytostatic small molecular-weight molecules. The first edition of this book (Humana Press, 2000) was also the first comprehensive presentation of the concept of cancer as a “disease process” involving key regulatory pathways. The second edition (2004) reaffirmed this dynamic concept, incorporating more recent evidence, and introducing such new topics of special interest as the combination of molecular diagnostics--expression profiling of genes and proteins--with developmental therapeutics, and the “binary state” concept (active/inactive) that seeks more relevant targets within the global molecular matrix of a given cancer. Comprehensive and intellectually stimulating, POMO III not only clearly elucidates the fundamentals of this dramatically advancing field, but also interprets the vast and often complex molecular data available. It fills a much neglected gap between “information” and “knowledge”, and holds out the hope of new anticancer strategies that will reduce cancer cell proliferation and significantly reduce metastasis.

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.

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.

Clinical Trial Registries: A Practical Guide for Sponsors and Researchers of Medicinal Products is a necessary addition to the library of all researchers who plan to publish their results in top-tier, peer-reviewed journals. ICMJE editors and other journal editors require registration of clinical trial information on publicly available Web sites before enrollment of study subjects and some countries and regions also require this information, as well as timely publication of study results. Not only does this book discuss the genesis of these requirements, it also provides practical information for researchers and sponsors on how to establish a workflow for a clinical registry project, how to file to a registry, and how to post results. More than 25 current Web addresses for registries are provided as well as a comprehensive annotated bibliography of papers on the topic of clinical trial registries. This book is a valuable source of information for all sponsors of medicinal products.

This book describes the authors’ standard or ‘best’ practices used in writing regul- ed clinical documents for the drug and biologics industry. The fundamental premise of this book is that the end (documents submitted to a health authority) is dep- dent on the beginning (the planning and strategy that go into organizing written documentation). Each regulatory document inherently exists within a constellation of related documents. This book attempts to show the relationships between and among these documents and suggests strategies for organizing and writing these documents to maximize ef?ciency while developing clear and concise text. At all times, and irrespective of applicable laws and guidelines, good communication skills and a sense of balance are essential to adequately, accurately, and clearly describe a product’s characteristics. At no time should the reader perceive these suggestions to be the only viable solution to writing regulatory documents nor should the reader expect that these suggestions guarantee product success. The audience for this book is the novice medical writer, or those who would like to explore or enhance regulatory-writing skills. We assume the reader will have a basic understanding of written communication, but little experience in applying this skill to the task of regulatory writing. Extensive knowledge of science, clinical me- cine, mathematics, or regulatory affairs law is not required to use the best practices described in this book.