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Further challenges extend throughout the product development cycle from raw material control to clinical study design.  The regulatory landscape is rapidly changing as new types of complex mixtures are introduced into clinical trials and to the market (e.g., traditional Chinese medicines and medical marijuana products), while older products are facing generic competition for the first time (e.g., enoxaparin). The future outlook for complex generic drug products, as opposed to the more commonly developed targeted single agent drug products is not clear.  The risks pertaining to lack of a full understanding of raw material control, process and controls in manufacture, as well as characterization of a complex mixture were seen vividly during the heparin crisis of 2008. As such powerful lessons have been learned about the regulatory science specific to complex products. 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Es dient Berufseinsteigern als breit angelegtes Lehrmittel und erfahrenen Fachkräften als Nachschlagewerk mit übersichtlich dargestellten theoretischen Grundlagen und konkreten, erprobten Anwendungsideen. \u003c\/p\u003e\n\u003cp\u003eDie theoretischen Grundlagen für jedes Kapitel sind gut lesbar abgefasst und unterstützen das Verständnis für praktische Arbeiten und Gerätefunktionen. Zu jedem Kapitel gibt es Hinweise auf vertiefende und weiterführende Literatur. Arbeitssicherheit und –hygiene sowie die zwölf Prinzipien der nachhaltigen Chemie finden neben den entsprechenden Kapiteln Beachtung. Die im Buch erwähnten praktischen Grundlagen gründen auf Gegebenheiten in der chemisch-pharmazeutischen Industrie in der Schweiz. Sie finden im gesamten deutschsprachigen Raum Anwendung, auch in verwandten Arbeitsgebieten wie biochemischen, klinischen, werkstoffkundlichen oder universitären Laboratorien.\u003c\/p\u003e\n\u003cp\u003eDie Laborpraxis eignet sich für den Einsatz in der Grund- und in der Weiterbildung von Fachpersonal. Der Inhalt entspricht den aktuellen Anforderungen der Bildungsverordnung und des Bildungsplanes zum Beruf L\u003ci\u003eaborantin \/ Laborant mit eidgenössischem Fähigkeitszeugnis\u003c\/i\u003e (EFZ), welche vom Staatssekretariat für Bildung, Forschung und Innovation (SBFI) in Bern verordnet wurden. Damit steht den Lernenden eine gute Grundlage für die Vorbereitung auf das Qualifikationsverfahren (QV) zur Verfügung; Expertinnen und Experten stützen ihre persönlichen Vorbereitungsarbeiten und ihre fachlichen Beurteilungen auf dieses Buch. \u003c\/p\u003e\n\u003cp\u003eBand 1 und Band 2 behandeln ausführlich die Grundlagen der Laborarbeit und ausgewählte Messtechniken. 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It reviews and summarizes selected important case studies in genetic methods applied to enhance the production of a given metabolite or a group of related or derived compounds. Readers will find reference information on a multitude of techniques and methods, including traditional breeding and screening; over-expression of genes encoding key enzymes; functional genomics approaches; metabolic engineering of the relevant biosynthetic pathways; indirect genetic approaches to improve metabolite production, including Agrobacterium mediated transformations. Furthermore, combinatorial biochemistry approaches to engineer secondary metabolic pathways are summarized, which can offer access to new structures or to the design of novel compounds. Since many commercially valuablesubstances are still extracted from plants, being largely inaccessible to efficient modern laboratory synthesis methods, this book provides a valuable resource of information for biotechnological approaches that can help to find alternative and more efficient methods for the production of natural secondary metabolites. Thus adjusted production methods, with the help of tailored plant systems, can potentially help to release the stress on plants, which are currently suffering from extensive human harvesting, and to conserve global biodiversity. Readers will find comprehensive reference information on plant genetic manipulation toward more efficient synthesis, accumulation and production of target secondary metabolites. 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A wide range of problems such as flow obstructions, segregation and vibrations are discussed. The content helps to understand the powder flow and provides practical solutions. The fundamentals of bulk solids flow are outlined: particle–particle interactions, stress, friction, strength, density, flow properties and methods of measurement, shear testers and other test procedures, specific properties of powders and how they are influenced by moisture, temperature and flow agents. The application of the flow properties in the design of properly working bulk solid containers like bins, silos and hoppers is also explored. Besides, the book also covers the technical design of silo walls, feeders, discharge aids, inserts, the assessment of stresses in silos, segregation and how to avoid it and vibrations or shocks occurring in silos\u003c\/p\u003e","brand":"Gardners","offers":[{"title":"Default Title","offer_id":52911246999831,"sku":null,"price":13700.64,"currency_code":"INR","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0679\/6918\/8119\/files\/9783030767204.jpg?v=1781264259"},{"product_id":"laborpraxis-band-3-trennungsmethoden-9783034809702","title":"Laborpraxis Band 3: Trennungsmethoden","description":"\u003cp\u003eDas vierbändige Standardwerk für die grundlegende praktische Arbeit im chemisch-pharmazeutischen Labor mit Schwerpunkt Synthesemethoden, Chromatographie und Spektroskopie liegt jetzt in der 6. völlig neu überarbeiteten Auflage vor. Es dient Berufseinsteigern als breit angelegtes Lehrmittel und erfahrenen Fachkräften als Nachschlagewerk mit übersichtlich dargestellten theoretischen Grundlagen und konkreten, erprobten Anwendungsideen. Die theoretischen Grundlagen für jedes Kapitel sind gut lesbar abgefasst und unterstützen das Verständnis für praktische Arbeiten und Gerätefunktionen. Zu jedem Kapitel gibt es Hinweise auf vertiefende und weiterführende Literatur. Arbeitssicherheit und –hygiene sowie die zwölf Prinzipien der nachhaltigen Chemie finden neben den entsprechenden Kapiteln Beachtung. Die im Buch erwähnten praktischen Grundlagen gründen auf Gegebenheiten in der chemisch-pharmazeutischen Industrie in der Schweiz. Sie finden im gesamten deutschsprachigen Raum Anwendung, auch in verwandten Arbeitsgebieten wie biochemischen, klinischen, werkstoffkundlichen oder universitären Laboratorien. Die Laborpraxis eignet sich für den Einsatz in der Grund- und in der Weiterbildung von Fachpersonal. Der Inhalt entspricht den aktuellen Anforderungen der Bildungsverordnung und des Bildungsplanes zum Beruf Laborantin \/ Laborant mit eidgenössischem Fähigkeitszeugnis (EFZ), welche vom Staatssekretariat für Bildung, Forschung und Innovation (SBFI) in Bern verordnet wurden. Damit steht den Lernenden eine gute Grundlage für die Vorbereitung auf das Qualifikationsverfahren (QV) zur Verfügung; Expertinnen und Experten stützen ihre persönlichen Vorbereitungsarbeiten und ihre fachlichen Beurteilungen auf dieses Buch. Band 1 und Band 2 behandeln ausführlich die Grundlagen der Laborarbeit und ausgewählte Messtechniken. Band 3 ist auf präparative und analytische Trennungsmethoden, Band 4 auf nasschemische und spektroskopische Analysemethoden fokussiert. Sowohl konventionelle Methoden als auch modernste Techniken finden Erwähnung. 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The strength of this text is in its emphasis on normative ethics and critical thinking, and that there is truly a best answer in the vast majority of cases, no matter how complex. The authors place high trust in a pharmacist’s moral judgment. This teaches the reader how to think, based on ethical principles, not necessarily what to think. This means navigating between the two extremes of overly theoretical and excessively prescriptive. The cogent framework given in this text uses the language of competing duties, identifying the moral principles at stake that create duties for the pharmacist. This is the balancing act of normative ethics, and of deciding which duties should prevail in a given clinical situation. This work presents a clear-cut pathway for resolving ethical dilemmas encountered by pharmacists, based on foundational principles and critical thinking. 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The book also includes chapters on quality by design (QbD) and process analytical technology (PAT) for continuous processing, process control strategies including new concepts of quality-by-control (QbC), real-time process management and plant optimization, business and supply chain considerations related to continuous manufacturing as well as safety guidelines related to continuous chemistry. A separate chapter is dedicated to discussing regulatory aspects of continuous manufacturing, with description of current regulatory environment quality\/GMP aspects, as well as regulatory gaps and challenges.Our aim from publishing this book is to make it a valuable reference for readers interested in this topic, with a desire to gain a fundamental understanding of engineering principles and mechanistic studies utilized in understanding and developing continuous processes. 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