At last! The book for anyone who writes regulatory documents or wishes to learn more about writing regulatory documents for the biopharmaceutical industry. Targeted Regulatory Writing Techniques: Clinical Documentation for Drugs and Biologics, written by 2 well-known regulatory writers with a combined 40 years experience, provides detailed information on a ~targeteda (TM) writing. Many books, papers, and Web sites provide information on what needs to be written and submitted to regulatory authorities, but this comprehensive book shows you how to approach the writing task in a logical process that permits rapid completion of writing.

Targeted Regulatory Writing Techniques is the first comprehensive book of regulatory writing for the biopharmaceutical industry, and covers specific documents types, as well as submission to all major regions of the world. The book provides a a ~targeteda (TM) method of document development -- a way of planning for information flow that maximizes efficiency and speed to submission. The book has a hands-on approach to identifying methods that quickly determine which document is required, how to write it, and how it fits into submission types. The authors share their experiences with numerous a ~Lessons Learneda (TM) side bars of information.

Targeted Regulatory Writing Techniques takes the reader from regulatory writing fundamentals, templates, and style guides through source documents (protocols and clinical study reports) to integrated documents (investigatora (TM)s brochures, IMPD. ISS, ISE, and informed consents) to global submissions in Europe, Japan, and the United States. The comprehensive appendices provide examples of checklists, actualdocuments, and the submission forms required for Japan. An extensive glossary of terms is included.

In summary, Targeted Regulatory Writing Techniques: Clinical Documentation for Drugs and Biologics offers a quick start up for the discipline, including regulatory context within which writing is performed.

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.

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.

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.

This second edition is a one-source guide to current information about red blood cell physiology and the action of native and recombinant human erythropoietic factors. Topics in the fields of erythropoiesis, recombinant protein discovery and production, and treatment of patients with anemia due to renal failure, cancer, or chronic diseases are covered. The newest theories in erythropoiesis (receptors, signaling), manufacturing, new formulations, and clinical research are discussed.

This book is of interest to researchers and clinical investigators in academia and biotechnology and pharmaceutical companies, to clinical research associates, clinical monitors, and physician investigators.

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.