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New Drug Development : An Introduction to Clinical Trials: Second Edition
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ISBN: 9781441964182 9781441964175 9781493900916 9781441964199 9781493991921 Year: 2010 Publisher: New York, NY Springer

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New Drug Development, 2nd Edition, is a reader-friendly introduction to clinical trials that is written specifically for entry-level professionals in the pharmaceutical, biopharmaceutical, and contract research organization (CRO) industries. It is also excellent reading for seasoned clinical research professionals who wish to refresh their knowledge in areas outside their immediate fields of expertise, and for students of clinical research, pharmacy, medicine, nursing, and allied health professions. While the main focus is on preapproval clinical trials, the book adopts a lifecycle drug development approach, placing these trials in the overall continuum from drug discovery to postmarketing surveillance. It therefore contains brief discussions of medicinal chemistry, nonclinical research, drug manufacturing, and the latest techniques for gathering information concerning adverse drug reactions. This edition builds on the success of the first edition by keeping the discussions that were most helpful to readers, and adding new chapters addressing important contemporary topics in drug development. The chapters dealing with the design and analysis of clinical trials in the first edition received praise from many sources. This new edition incorporates extended discussions of the operational aspects of conducting various kinds of trials, ranging from highly specialized and relatively small cardiac safety studies to very large, multi-site Phase III trials run in several different countries.


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Ik heb barstende hoofdpijn
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ISBN: 9789031378869 Year: 2010 Publisher: Houten Bohn Stafleu Van Loghum

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Als apothekersassistent ben je een ware duizendpoot. Je voert uiteenlopende taken uit. Het beroep brengt bovendien veel verantwoordelijkheid met zich mee: zowel de klant als de apotheker rekenen op je. Een kleine vergissing kan grote gevolgen hebben. Daarom is het belangrijk dat je over de juiste competenties en kennis beschikt en deze geïntegreerd toe kunt passen. &#13;&#13;In de serie werkboeken Casuïstiek voor apothekersassistenten staat steeds een andere groep klanten centraal. Telkens gaat het om mensen met klachten die op het eerste gezicht op elkaar lijken maar die verschillende oorzaken hebben. &#13;Zo hebben de klanten in dit werkboek allemaal last van zware hoofdpijn. &#13;&#13;De serie helpt je om je goed voor te bereiden op de beroepspraktijk, met casuïstiek kun je op een prettige en veilige manier oefenen met verschillende zorgvragen. Via praktische opdrachten kom je in aanraking met de verschillende &#13;kerntaken van de apothekersassistent. Sommige opdrachten maak je alleen, andere voer je uit in een klein groepje of met al je studiegenoten samen. &#13;&#13;&#13;Om het probleem van de klant te kunnen begrijpen sta je stil bij de bouw en werking van het centrale zenuwstelsel. Je bestudeert een aantal veel voorkomende aandoeningen die gepaard gaan met hevige hoofdpijn en leert wanneer er sprake is van alarmfactoren. &#13;Je kijkt naar de geneesmiddelen die ingezet kunnen worden ter bestrijding van hoofdpijn en de achterliggende oorzaken daarvan. Hoe werken deze medicijnen en wat moet je klanten vertellen over de manier waarop ze deze wel en niet moeten gebruiken? &#13;Je neemt recepten in voor dergelijke geneesmiddelen en oefent met het verhelderen van zelfzorgvragen bij dit type klachten. &#13;Je bereidt een aantal geneesmiddelen tegen hoofdpijn die regelmatig door de apotheek gemaakt of aangepast worden. &#13;Je ontdekt het belang van actief luisteren tijdens gesprekken met klanten. Daarnaast sta je stil bij de schriftelijke materialen die je bij het geven van voorlichting kunt gebruiken. &#13;Ook komt een aantal administratieve taken aan bod, zoals het verwerken van klantgegevens in het Apotheek Informatie Systeem en het bestellen van medicijnen. &#13;Je staat stil bij de rechten van de klant: aan welke wettelijke eisen moeten zorgverleners zich houden? &#13;Omdat hoofdpijn een gevolg kan zijn van stress ga je na in hoeverre stress onze samenleving in zijn greep heeft. &#13;&#13;Leren houdt nooit op, het is belangrijk om je steeds te blijven ontwikkelen. Bijvoorbeeld op het vlak van mensenkennis. Daarom eindigt dit werkboek met een opdracht over verschillende drijfveren die mensen kunnen hebben.&#13;&#13;


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Fortschritte der Chemie organischer Naturstoffe / Progress in the Chemistry of Organic Natural Products, Vol. 92
Authors: --- --- ---
ISBN: 9783211996614 9783211997963 9783211996607 9783709111031 Year: 2010 Publisher: Vienna Springer Vienna

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Resin glycosides are part of a very extensive family of secondary metabolites known as glycolipids or lipo-oligosaccharides and are constituents of complex resins (glycoresins) (1) unique to the morning glory family, Convolvulaceae (2). These active principles are responsible for the drastic purgative action of all the important Convolvulaceous species used in traditional medicine throughout the world since ancient times. Several commercial purgative crude drugs can be prepared from the roots of different species of Mexican morning glories. Their incorporation as therapeutic agents in Europe is an outstanding example of the assimilation of botanical drugs from the Americas as substitutes for traditional Old World remedies (3). Even though phytochemical investigations on the constituents of these drugs were initiated during the second half of the nineteenth century, the structure of their active ingredients still remains poorly known for some examples of these purgative roots. During the last two decades, the higher resolution c- abilities of modern analytical isolation techniques used in conjunction with pow- ful spectroscopic methods have facilitated the elucidation of the active principles of these relevant herbal products. This chapter describes the ethnobotanical information associated with the p- gative morning glory species and how traditional usages were instrumental in plant selection for chemical studies. The advantages and limitations of available analy- cal techniques for the isolation, puri?cation, and structure characterization of the individual constituents of these complex glycoconjugates are also discussed.


Multi
Fortschritte der Chemie organischer Naturstoffe / Progress in the Chemistry of Organic Natural Products, Vol. 92
Authors: --- --- ---
ISBN: 9783211996614 9783211997963 9783211996607 9783709111031 Year: 2010 Publisher: Vienna Springer Vienna

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Abstract

Resin glycosides are part of a very extensive family of secondary metabolites known as glycolipids or lipo-oligosaccharides and are constituents of complex resins (glycoresins) (1) unique to the morning glory family, Convolvulaceae (2). These active principles are responsible for the drastic purgative action of all the important Convolvulaceous species used in traditional medicine throughout the world since ancient times. Several commercial purgative crude drugs can be prepared from the roots of different species of Mexican morning glories. Their incorporation as therapeutic agents in Europe is an outstanding example of the assimilation of botanical drugs from the Americas as substitutes for traditional Old World remedies (3). Even though phytochemical investigations on the constituents of these drugs were initiated during the second half of the nineteenth century, the structure of their active ingredients still remains poorly known for some examples of these purgative roots. During the last two decades, the higher resolution c- abilities of modern analytical isolation techniques used in conjunction with pow- ful spectroscopic methods have facilitated the elucidation of the active principles of these relevant herbal products. This chapter describes the ethnobotanical information associated with the p- gative morning glory species and how traditional usages were instrumental in plant selection for chemical studies. The advantages and limitations of available analy- cal techniques for the isolation, puri?cation, and structure characterization of the individual constituents of these complex glycoconjugates are also discussed.


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Het cardiovasculair formularium : een praktische leidraad
Authors: --- --- ---
ISBN: 9789031373659 Year: 2010 Publisher: Houten Bohn Stafleu Van Loghum

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Deel 1 cardiovasculaire aandoeningen1. Cardiovasculaire risicomanagement2. Dyslipoproteïnemie3. Hypertensie4. Acuut coronairsyndroom5. Stabiele angina pectoris6. Hartfalen7. Hartritmestoornissen8. Perifere vaatziekten9. Cerebrovasculaire ziekten10. Diepe veneuze trombose en longembolie11. Diagnostiek in de cardiologieDeel 2 Cardiovasculaire geneesmiddelen12. Antiritmica13. Antithrombotica14. Bètablokkers15. Diuretica16. Calciumantagonisten17. ACE-remmers18. Angiotensine-II receptorenantagonisten en directe renineremmers19. Nitraten20. Lipidenverlagende geneesmiddelen.


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Current Trends in Monoclonal Antibody Development and Manufacturing
Authors: --- --- --- ---
ISBN: 9780387766430 9780387568263 9780387766423 9781461424918 Year: 2010 Publisher: New York, NY Springer New York

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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.


Book
Naturally Occurring Organohalogen Compounds - A Comprehensive Update
Authors: ---
ISBN: 9783211993231 9783211993248 9783709110997 9783211993224 Year: 2010 Publisher: Vienna Springer Vienna

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Despite the long association of organohalogen compounds with human activities, nature is the producer of nearly 5,000 halogen-containing chemicals. Once dismissed as accidents of nature or isolation artifacts, organohalogen compounds represent an important and ever growing class of natural products, in many cases exhibiting exceptional biological activity. Since the last comprehensive review in 1996 (Vol. 68, this series), there have been discovered an additional 2,500 organochlorine, organobromine, and other organohalogen compounds. These natural organohalogens are biosynthesized by bacteria, fungi, lichen, plants, marine organisms of all types, insects, and higher animals including humans. These compounds are also formed abiogenically, as in volcanoes, forest fires, and other geothermal events.In some instances, natural organohalogens are precisely the same chemicals that man synthesizes for industrial use, and some of the quantities of these natural chemicals far exceed the quantities emitted by man.


Book
Pharmaceutical Suspensions
Authors: --- --- ---
ISBN: 9781441910875 9781441910882 9781441910868 9781489984173 9781071605745 Year: 2010 Publisher: New York, NY Springer New York

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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"


Book
Pharmaceutical Stability Testing to Support Global Markets
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ISBN: 9781441908896 9781441908902 9781461425366 9781441908889 Year: 2010 Publisher: New York, NY Springer New York

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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.


Book
Post-Transcriptional Regulation by STAR Proteins : Control of RNA Metabolism in Development and Disease
Authors: --- ---
ISBN: 9781441970053 9781441970046 9781441970060 9781489978059 Year: 2010 Publisher: Boston MA Springer US

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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.

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