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History of human medicine --- Psychiatry --- psychiatrie --- Germany
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Monoclonal antibodies represent one of the fastest growing areas of new drug development within the pharmaceutical industry. Several blockbuster products have been approved over the past several years including Rituxan, Remicade, Avastin, Humira, and Herceptin. In addition, over 300 new drugs are currently in clinical trials. With both large, established biotechnology companies and small start-ups involved in the development of this important class of molecules, monoclonal antibodies products will become increasingly prevalent over the next decade. Recently the regulatory review of monoclonal antibodies has been moved from Center for Biologics and Research to the Center for Drug Evaluation and Research (CDER) division of the US Food and Drug Administration. It is anticipated that CDER will expect a certain minimal amount of data to be provided as more of these products move through the regulatory pipeline. Current Trends in Monoclonal Antibody Development and Manufacturing will provide readers with an understanding of what is currently being done in the industry to develop, manufacture, and release monoclonal antibody products and what will be required for a successful regulatory submission.
History of human medicine --- Pharmacology. Therapy --- Neuropathology --- neurologie --- farmacologie --- toxicologie
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Suspension dosage form is a preferred and widely accepted dosage forms for insoluble or poorly soluble drugs for various therapeutic applications. The suspension dosage form has long been used for insoluble and poorly soluble drugs for making oral, topical and parenteral products. Pharmaceutical Suspensions, From Formulation Development to Manufacturing provides the reader with a broad overview of suspension drug product technology. Individual chapters in this book focus on suspension formulation principles, excipients, analysis, pharmaceutical development, preclinical, clinical and regulatory aspects, as well as the emerging technology of nanosuspensions as nanomedicine. Various chapters in the book are written by authors from academia, regulatory agencies and industries who are experts in their respective fields. The book includes over 600 bibliographic citations, numerous tables and illustrations. Pharmaceutical Suspensions is the only volume to date that systematically follows the suspension dosage development approach used widely in the pharmaceutical industries starting with pre-formulation/formulation development, pre-clinical evaluation and critical characterization method development, continuing to clinical trial essentials and ending with technology transfer essentials and regulatory filing guidance. Pharmaceutical Suspensions, From Formulation Development to Manufacturing provides a useful resource for pharmaceutical scientists, process scientists/engineers involved in the areas of research and development of pharmaceutical suspension dosage forms as well as for advanced pharmacy undergraduate and graduate students who want in-depth knowledge of suspension dosage form. "Solid useful text on suspension formulation development"
History of human medicine --- Pharmacology. Therapy --- farmacologie --- toxicologie
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The International Conference of Harmonization (ICH) has worked on har- nizing the stability regulations in the US, Europe, and Japan since the early 1990s. Even though the Stability Guidelines Q1A (R2) was issued over a decade ago, issues surrounding this arena continue to surface as the principles described in the guideline are applied to different technical concentrations. As a result, the stability community has continued to discuss concerns and find ways of harmonizing regulatory requirements, streamlining practices, improving processes in order to bring safe and effective medical supplies to the patients around the world. In 2007, the American Association of Pharmaceutical Scientists (AAPS) Stability Focus Group organized two workshops - the Stability Workshop and the Degradation Mechanism Workshop. These meetings attracted many industry scientists as well as representatives from several regulatory agencies in the world to discuss important topics related to pharmaceutical stability practices. Recognizing the importance of documenting these discussions and with the permission of AAPS, I have worked with speakers to assemble a collection of 30 articles from presentations given at these two meetings, mainly the Stability Workshop. I trust that this book will be beneficial to all of you in providing guidance and up-to-date information for building quality stability programs. v Freedom of our mind is Mother of all inventions.
History of human medicine --- Pharmacology. Therapy --- farmacologie --- toxicologie
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This book aims to bring to the forefront a field that has been developing since the late 1990s called the STAR pathway for Signal Transduction and Activation of RNA. It is a signaling pathway that targets RNA directly; in contrast to the canonical signal kinase cascade transcription factor DNA RNA. It is proposed to allow quick responses to environment changes such as those necessary in many biological phenomenona such as the nervous system, and during development. The pathway is diagramed in Chapter 1, Figure1. This chapter is a historical introduction and general review with some new data on theoretical miRNAs binding sites and STAR mRNAs. In Chapter 2, Feng and Banks address the accumulating evidence that the RNA-binding activity and the homeostasis of downstream mRNA targets of STAR proteins can be regulated by phosphorylation in response to various extracellular signals. Then Ryder and Massi review the available information on the structure of the RNA binding STAR domain and provides insights into how these proteins discriminate between different RNA targets. Next Claudio Sette offers an overview of the post-translational modifications of STAR proteins and their effects on biological functions, followed by two chapters dedicated to in depth review of STAR function in spermatogenesis and in mammalian embryonic development. Chapters 7 and 8 discuss what can be learned from STAR proteins in non-mammalian species; in Drosophila and Gld-1 and Asd-2 in C. elegans. Next Rymond discusses the actual mech- ics of splicing with mammalian SF1.
History of human medicine --- Pharmacology. Therapy --- Neuropathology --- neurologie --- farmacologie --- toxicologie
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