Blow-fill-seal Technology PDF Download
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Author: R. Oschmann
Publisher: Taylor & Francis US
ISBN: 9783804716209
Category : Science
Languages : en
Pages : 136
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Book Description
Author: R. Oschmann
Publisher: Taylor & Francis US
ISBN: 9783804716209
Category : Science
Languages : en
Pages : 136
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Book Description
Author: Kenneth E. Avis
Publisher: CRC Press
ISBN: 1000161641
Category : Medical
Languages : en
Pages : 400
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Book Description
In this unique book, experts describe practices applicable to the large-scale processing of biotechnological products. Beginning with processing and bulk storage preservation techniques, the book provides strategies for improving efficiency of process campaigns of multiple products and manufacturing facilities for such processing techniques. Large-scale chromatography for the purification of biomolecules in manufacturing and lyophilization of protein pharmaceuticals are discussed. Includes a case study on blow-fill-seal processing technology and a chapter on economic and cost factors for bioprocess engineering.
Author: Anne Booth
Publisher: Routledge
ISBN: 1351413805
Category : Medical
Languages : en
Pages : 430
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Book Description
This book presents vital information on international sterilization standards and guidance on practical application of these standards in the manufacturing process. It covers validation, industrial sterilization methods, emerging sterilization techniques, laboratory testing, manufacturing of sterile devices, and device reuse. Excerpted from The Validator, edited by Anne F. Booth, more than fifty experts share their knowledge of current technologies in easy-to-understand articles that establish methods to ensure compliance. Contents include reviews of ISO sterilization standards, industrial sterilization methods and technologies, and support testing methodologies.
Author:
Publisher: Academic Press
ISBN: 012814422X
Category : Medical
Languages : en
Pages : 816
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Book Description
Dosage Form Design Parameters, Volume II, examines the history and current state of the field within the pharmaceutical sciences, presenting key developments. Content includes drug development issues, the scale up of formulations, regulatory issues, intellectual property, solid state properties and polymorphism. Written by experts in the field, this volume in the Advances in Pharmaceutical Product Development and Research series deepens our understanding of dosage form design parameters. Chapters delve into a particular aspect of this fundamental field, covering principles, methodologies and the technologies employed by pharmaceutical scientists. In addition, the book contains a comprehensive examination suitable for researchers and advanced students working in pharmaceuticals, cosmetics, biotechnology and related industries. - Examines the history and recent developments in drug dosage forms for pharmaceutical sciences - Focuses on physicochemical aspects, prefomulation solid state properties and polymorphism - Contains extensive references for further discovery and learning that are appropriate for advanced undergraduates, graduate students and those interested in drug dosage design
Author: Rodney Pearlman
Publisher: Springer Science & Business Media
ISBN: 9780306453328
Category : Medical
Languages : en
Pages : 470
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Book Description
Leading scientists offer detailed profiles of ten protein drugs currently in development. The case histories of these important new compounds are described from the perspective of their formulation, characterization, and stability. This ready reference also features recent data and an abundance of previously unpublished information. The in-depth coverage includes a highly useful compendium of degradation sites occurring in over 70 proteins. An invaluable aid in the rapid identification of potential `hot spots' in proteins, this accessible compilation allows for inspection of the protein's primary structure and preparation of a hydroflex plot.
Author: Jack Lysfjord
Publisher: Parenteral Drug Association
ISBN: 9781933722283
Category : Drugs
Languages : en
Pages : 405
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Book Description
Author: Alfred Fahr
Publisher: John Wiley & Sons
ISBN: 1118972449
Category : Medical
Languages : en
Pages : 1601
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Book Description
A textbook which is both comprehensive and comprehensible and that offers easy but scientifically sound reading to both students and professionals Now in its 12th edition in its native German, Voigt's Pharmaceutical Technology is an interdisciplinary textbook covering the fundamental principles of pharmaceutical technology. Available for the first time in English, this edition is produced in full colour throughout, with a concise, clear structure developed after consultation with students, instructors and researchers. This book: Features clear chapter layouts and easily digestible content Presents novel trends, devices and processes Discusses classical and modern manufacturing processes Covers all formulation principles including tablets, ointments, capsules, nanosystems and biopharmaceutics Takes account of legal requirements for both qualitative and quantitative composition Addresses quality assurance considerations Uniquely relates contrasting international pharmacopeia from EU, US and Japan to formulation principles Includes examples and text boxes for quicker data assimilation Written for both students studying pharmacy and industry professionals in the field as well as toxicologists, biochemists, medical lab technicians, Voigt’s Pharmaceutical Technology is the essential resource for understanding the various aspects of pharmaceutical technology.
Author:
Publisher: Universal Law Publishing
ISBN:
Category :
Languages : en
Pages : 588
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Book Description
Author: Dr. S. Valarmathi, Dr. Anasuya Patil, Dr. Abhishek Suman, Mr Vinay Kumar Yanmandru, Dr. NARLA SUNITHA, Prof. (Dr.) Varsha Deva
Publisher: Shashwat Publication
ISBN: 8119281241
Category : Medical
Languages : en
Pages : 452
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Book Description
This book structured in TWO different parts. These parts are as follows: Part I emphasizes on GCP (Good Clinical Practices), GLP (Good Laboratory Practices), GMP (Good Manufacturing Practices), USFDA-NDA/ANDA (U S Food and Drug Administrations- New Drug Approval/Abbreviated New Drug Approval) and TQM (Total Quality Management). GCP (Good Clinical Practices) is an international quality standard that is provided by International Conference on Harmonization (ICH), an international body that defines standards, which governments can transpose into regulations for clinical trials involving human subjects. Good Clinical Practice guidelines include protection of human rights as a subject in clinical trial. It also provides assurance of the safety and efficacy of the newly developed compounds. Good Clinical Practice Guidelines include standards on how clinical trials should be conducted, define the roles and responsibilities of clinical trial sponsors, clinical research investigators, and monitors. In the pharmaceutical industry monitors are often called Clinical Research Associates. GLP (Good Laboratory Practices) deals with the organization, process and conditions under which laboratory studies are planned, performed, monitored, recorded and reported. GLP practices are intended to promote the quality and validity of test data. Published GLP regulations and guidelines have a significant impact on the daily operation of an analytical laboratory. GMP (Good Manufacturing Practices) Manufacturing relies on the ability to reproduce exactly a single product hundreds, if not thousands, of times. To make this possible, guidelines have been drawn up in most countries that are similar to the FDA ones described here that define GMPs. Diagnostic companies, including those manufacturing and distributing biosensors, cannot sell their products for either public or professional use unless they have been approved on the basis of these guidelines. USFDA-NDA/ANDA (U S Food and Drug Ad
Author: José das Neves
Publisher: Springer Science & Business Media
ISBN: 1461495245
Category : Medical
Languages : en
Pages : 603
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Book Description
Biopharmaceutical medicines, the newest class of therapeutics, are quite heterogeneous and include a range of molecules such as proteins, peptides, vaccines and nucleic acids, with use in virtually all therapeutic fields (e.g. cancer and infectious diseases, vaccination, metabolic dysfunctions) and diagnostics. This edited book gives a concise and up-to-date overview of the biological features justifying the use of different human mucosa as delivery routes for biopharmaceuticals, the technological strategies that have been followed so far regarding the optimization of mucosal potentialities as well as the challenges that arise with the advent of new biopharmaceutical drugs and alternative means of administration. Following a brief introduction, the first section addresses general aspects of the biology of mucosal tissues and their unique aspects toward beneficial or deleterious interaction with biopharmaceuticals and their delivery systems. The second part reviews the different delivery strategies that have recently been investigated for different mucosal sites. The third section describes the development and clinical applications of drug delivery systems and products enclosing biopharmaceuticals for mucosal delivery, with a focus on the most successful case studies of recent years. The last section briefly centers on relevant aspects of the regulatory, toxicological and market issues of mucosal delivery of biopharmaceuticals. Scientists and researchers in the fields of drug delivery, material science, biomedical science and bioengineering as well as professionals, regulators and policy makers in the pharmaceutical, biotechnology and healthcare industries will find in this book an important compendium of fundamental concepts and practical tools for their daily research and activities.
