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Formulation And Analytical Development For Low Dose Oral Drug Products

Author: Jack Zheng
Publisher: John Wiley & Sons
ISBN: 9780470386354
Size: 44.36 MB
Format: PDF
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There are unique challenges in the formulation, manufacture, analytical chemistry, and regulatory requirements of low-dose drugs. This book provides an overview of this specialized field and combines formulation, analytical, and regulatory aspects of low-dose development into a single reference book. It describes analytical methodologies like dissolution testing, solid state NMR, Raman microscopy, and LC-MS and presents manufacturing techniques such as granulation, compaction, and compression. Complete with case studies and a discussion of regulatory requirements, this is a core reference for pharmaceutical scientists, regulators, and graduate students.

Developing Drug Products In An Aging Society

Author: Sven Stegemann
Publisher: Springer
ISBN: 3319430998
Size: 78.67 MB
Format: PDF, ePub
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This book aims to address the major aspects of future drug product development and therapy for older adults, giving practical guidance for the rational product and clinical development and prescribing of drug products to this ever growing segment of the population. With authors coming from key “aging” markets such as Europe, the USA, China and Japan, the book will provide valuable information for students, scientists, regulators, practitioners, and other healthcare professionals from academia, industry and regulatory bodies.

Continuous Manufacturing Of Pharmaceuticals

Author: Peter Kleinebudde
Publisher: John Wiley & Sons
ISBN: 1119001358
Size: 31.61 MB
Format: PDF
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A comprehensive look at existing technologies and processes for continuous manufacturing of pharmaceuticals As rising costs outpace new drug development, the pharmaceutical industry has come under intense pressure to improve the efficiency of its manufacturing processes. Continuous process manufacturing provides a proven solution. Among its many benefits are: minimized waste, energy consumption, and raw material use; the accelerated introduction of new drugs; the use of smaller production facilities with lower building and capital costs; the ability to monitor drug quality on a continuous basis; and enhanced process reliability and flexibility. Continuous Manufacturing of Pharmaceuticals prepares professionals to take advantage of that exciting new approach to improving drug manufacturing efficiency. This book covers key aspects of the continuous manufacturing of pharmaceuticals. The first part provides an overview of key chemical engineering principles and the current regulatory environment. The second covers existing technologies for manufacturing both small-molecule-based products and protein/peptide products. The following section is devoted to process analytical tools for continuously operating manufacturing environments. The final two sections treat the integration of several individual parts of processing into fully operating continuous process systems and summarize state-of-art approaches for innovative new manufacturing principles. Brings together the essential know-how for anyone working in drug manufacturing, as well as chemical, food, and pharmaceutical scientists working on continuous processing Covers chemical engineering principles, regulatory aspects, primary and secondary manufacturing, process analytical technology and quality-by-design Contains contributions from researchers in leading pharmaceutical companies, the FDA, and academic institutions Offers an extremely well-informed look at the most promising future approaches to continuous manufacturing of innovative pharmaceutical products Timely, comprehensive, and authoritative, Continuous Manufacturing of Pharmaceuticals is an important professional resource for researchers in industry and academe working in the fields of pharmaceuticals development and manufacturing.

Drug And Biological Development

Author: Ronald Evens
Publisher: Springer Science & Business Media
ISBN: 0387329781
Size: 68.36 MB
Format: PDF, Mobi
View: 511
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The book is a complete discussion of product development in the pharmaceutical and biotechnology industries from discovery, to product launch, and through life cycle management. Format is optimized for education and training of health care professionals, especially fellows in training (MD, PharmD, PhD), at universities. Format of the book is a set of figures, tables and lists, that can become power-point style slides as well, and the detailed narrative descriptions, including real-life examples, illustrations, controversies in industry, and references. Industry and research experts (multidisciplinary ' MD, PharmD, and PhD) are editors and authors. An added CD-ROM (slides only) enhances utility and marketability of book to course directors, providing the highly sought after slides for lectures.

3d And 4d Printing In Biomedical Applications

Author: Mohammed Maniruzzaman
Publisher: Wiley-VCH
ISBN: 3527344438
Size: 74.70 MB
Format: PDF, ePub, Docs
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Ein professioneller Leitfaden zu 3D- und 4D-Drucktechniken in der Biomedizin und Pharmazie. 3D and 4D Printing in Biomedical Applications führt fundiert in 3D- und 4D-Drucktechniken in der Biomedizin und Pharmazie ein. Dieses Fachbuch enthält Beiträge von internationalen Wissenschaftlern und Industrieexperten und bietet einen Überblick über das Thema, aktuelle Forschungsergebnisse und Innovationen zu Anwendungen in der Pharmazie und Biomedizin. Untersucht werden Prozessoptimierung, Innovationsprozesse, Engineering- und Plattformtechnologien. Darüber hinaus informiert das Werk über Entwicklungen in der Biomedizin, u. a. über Formgedächtnispolymere, Biofabrikation in 4D und Knochen aus dem Drucker. Eine Fülle von Themen werden behandelt und näher beleuchtet: Potenzial des 3D-Drucks für die Wirkstoffverabreichung, neue Fertigungsprozess, Bio-Scaffolding, neueste Trends und Herausforderungen für 3D- und 4D-Bioprinting in der Biofabrikation. Dieses wertvolle Referenzwerk - ist ein umfassender Leitfaden zu 3D- und 4D-Drucktechniken in der Biomedizin und Pharmazie. - informiert u. a. über die erste 3D-Druckplattform mit FDA-Zulassung für ein pharmazeutisches Erzeugnis. - enthält Reviews der derzeit verfügbaren pharmazeutischen Erzeugnisse, die per 3D-Druck hergestellt wurden. - präsentiert die jüngsten Fortschritte bei neuartigen Materialien für den 3D- und 4D-Druck und biomedizinische Anwendungen.

Generic Drug Product Development

Author: Leon Shargel
Publisher: CRC Press
ISBN: 1420086359
Size: 23.81 MB
Format: PDF, Kindle
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In this era of increased pharmaceutical industry competition, success for generic drug companies is dependent on their ability to manufacture therapeutic-equivalent drug products in an economical and timely manner, while also being cognizant of patent infringement and other legal and regulatory concerns. Generic Drug Product Development: Solid Oral Dosage Forms, Second Edition presents in-depth discussions from more than 30 noted specialists describing the development of generic drug products—from the raw materials to the development of a therapeutic-equivalent drug product to regulatory approval. Major topics discussed include: Active pharmaceutical ingredients Experimental formulation development, including a new section on Quality by Design (QbD) Scale-up Commercial product formulation Quality control and bioequivalence Drug product performance ANDA regulatory process Post-approval changes Post-marketing surveillance Legislative and patent challenges This second edition also contains a new chapter on the relationship between the FDA and the United States Pharmacopeia and in Chapter 4, using specific examples, the application of Quality by Design (QbD) during formulation development is examined.The book is a thorough guide to the development of solid oral generic dosage formulations. This textbook is ideal for the pharmaceutical industry, graduate programs in pharmaceutical sciences, and health professionals working in the area of generic drug development.

Formulierungstechnik

Author: Hans Mollet
Publisher: John Wiley & Sons
ISBN: 3527625712
Size: 15.81 MB
Format: PDF
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Viele chemische Stoffe und Verbindungen werden nicht in reiner Form angewandt. Um die beste Entfaltung des Wirkstoffes zu ermöglichen oder die optimalen Handels- oder Verkaufsform zu erreichen, schließen sich an die Synthese und Reinigung die Aufbereitung und Formulierung an. Die Palette der Handelsformen reicht von Pulvern, Agglomeraten, Granulaten, Suspensionen, Slurries, Emulsionen, Mikroemulsionen, Mikrokapseln, Instantpräparaten, Liposomen bis hin zu Tabletten und Dragees. Die Formulierung kann je nach Präparat in einer einfachen Mischoperation bestehen oder kompliziertere verfahrenstechnische Schritte, wie Zerkleinern, Dispergieren, Emulgieren, Agglomerieren, Solubilisieren, Trocknen usw. einschließen. Sie spannt den Bogen von der Kolloid- und Grenzflächenchemie zur Verfahrenstechnik. In diesem Buch werden die für den Formulierungschemiker in der Industrie wesentlichen physikalisch-chemischen Grundlagen und Anwendungen in der chemischen Industrie, z.B. für Pharmazeutika, Agrochemikalien, Pigmente, Farbstoffe, Lebensmittel, Additive, Waschmittel und Kosmetika sowie die geeigneten Hilfsmittel für die Struktur-Wirkungsbeziehung übersichtlich und praxisnah beschrieben.