practical pharmaceutics an international guideline for the preparation care and use of medicinal products

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Practical Pharmaceutics

Author : Yvonne Bouwman
ISBN : 9783319158143
Genre : Medical
File Size : 31. 3 MB
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This book contains essential knowledge on the preparation, control, logistics, dispensing and use of medicines. It features chapters written by experienced pharmacists working in hospitals and academia throughout Europe, complete with practical examples as well as information on current EU-legislation. From prescription to production, from usage instructions to procurement and the impact of medicines on the environment, the book provides step-by-step coverage that will help a wide range of readers. It offers product knowledge for all pharmacists working directly with patients and it will enable them to make the appropriate medicine available, to store medicines properly, to adapt medicines if necessary and to dispense medicines with the appropriate information to inform patients and caregivers about product care and how to maintain their quality. This basic knowledge will also be of help to industrial pharmacists to remind and focus them on the application of the medicines manufactured. The basic and practical knowledge on the design, preparation and quality management of medicines can directly be applied by the pharmacists whose main duty is production in community and hospital pharmacies and industries. Undergraduate as well as graduate pharmacy students will find knowledge and backgrounds in a fully coherent way and fully supported with examples.

In Vitro And In Vivo Tools In Drug Delivery Research For Optimum Clinical Outcomes

Author : Ambikanandan Misra
ISBN : 9781351368711
Genre : Medical
File Size : 66. 16 MB
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This book covers the essentials of drug delivery research and provides a unique forum for scientific experimental methods that are exclusively focused by the in-vitro, ex-vivo, and in-vivo methodologies of drug delivery research and felicitates translational research. The book includes recent and novel approaches in evaluation methods of transdermal, nasal, ocular, oral and intraoral, gastro-retentive, colon-targeted, and brain-targeted drug delivery systems. Providing up to date and comprehensive information, this text is invaluable to students, teachers, scientists, and others employed in the field of drug delivery.

Inhaled Pharmaceutical Product Development Perspectives

Author : Anthony J. Hickey
ISBN : 9780128123362
Genre : Science
File Size : 70. 99 MB
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Inhaled Pharmaceutical Product Development Perspectives: Challenges and Opportunities describes methods and procedures for consideration when developing inhaled pharmaceuticals, while commenting on product development strategies and their suitability to support regulatory submission. It bridges the gap between the aspirations of scientists invested in new technology development and the requirements that must be met for any new product. The book brings together emerging analytical and inhalation technologies, providing perspectives that illuminate formulation and device design, development, regulatory compliance, and practice. Focusing on underlying scientific and technical principles known to be acceptable from the current regulatory perspective, this monograph will remain useful as a high-level guide to inhaled product development for the foreseeable future. Discusses development strategies and best practices in the context of regulatory requirements Written by a broadly qualified expert drawing on the knowledge and critical opinions of key individuals in the field Includes a foreword by Charles G. Thiel

Effective Drug Regulation

Author : Ratanawijitrasin S
ISBN : 9789241562065
Genre : Medical
File Size : 63. 42 MB
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Seven independent variables were used including the five financing instruments, the firm's ordinary debt, and the firm's operating risk.

Who Expert Committee On Specifications For Pharmaceutical Preparations

Author : World Health Organization
ISBN : 9789241209298
Genre : Business & Economics
File Size : 80. 18 MB
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This report discusses the monographs on antiretrovirals proposed for inclusion in The International Pharmacopoeia and specifications for radiopharmaceuticals, quality specifications for antituberculosis drugs and the revision of the monograph on artemisinin derivatives, as well as quality control of reference materials, good manufacturing practices, inspection, distribution and trade, and other aspects of quality assurance of pharmaceuticals, and regulatory issues. Several annexes include an amendment togood manufacturing practices: main principles regarding the requirement for the sampling of starting materials, guidelines on good manufacturing practices regarding water for pharmaceutical use, guidelines on the sampling of pharmaceutical products, and draft guidelines for registration of fixed-dose combination medicinal products.

Regulating Pharmaceuticals In Europe Striving For Efficiency Equity And Quality

Author : Mossialos, Elias
ISBN : 9780335226559
Genre : Education
File Size : 26. 54 MB
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The rising cost of pharmaceutical expenditures in many European countries is of concern to governments required to make effective use of health care budgets. Taking a broad perspective that encompasses institutional, political and supranational aspects of pharmaceutical regulation, this book examines approaches used to manage pharmaceutical expenditure across Europe and what impact these strategies have had on efficiency, quality, equity and cost of pharmaceutical care. Regulating Pharmaceuticals in Europe is an important book for students of health policy, regulation and management, and for health managers and policy makers.

Drug And Biological Development

Author : Ronald Evens
ISBN : 9780387329789
Genre : Medical
File Size : 59. 1 MB
Format : PDF
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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.

The Physics Of The Mind And Brain Disorders

Author : Ioan Opris
ISBN : 9783319296746
Genre : Medical
File Size : 66. 87 MB
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This book covers recent advances in the understanding of brain structure, function and disorders based on the fundamental principles of physics. It covers a broad range of physical phenomena occurring in the brain circuits for perception, cognition, emotion and action, representing the building blocks of the mind. It provides novel insights into the devastating brain disorders of the mind such as schizophrenia, dementia, autism, aging or addictions, as well as into the new devices for brain repair. The book is aimed at basic researchers in the fields of neuroscience, physics, biophysics and clinicians in the fields of neurology, neurosurgery, psychology, psychiatry.

The Challenge Of Cmc Regulatory Compliance For Biopharmaceuticals

Author : John Geigert
ISBN : 9781441991317
Genre : Medical
File Size : 35. 73 MB
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"The greater our knowledge increases, the more our ignorance unfolds. " U. S. President John F. Kennedy, speech, Rice University, September 12, 1962 My primary purpose for writing this book was much more than to provide another information source on Chemistry, Manufacturing & Controls (CMC) that would rapidly become out of date. My primary purpose was to provide insight and practical suggestions into a common sense business approach to manage the CMC regulatory compliance requirements for biopharmaceuticals. Such a common sense business approach would need (1) to be applicable for all types of biopharmaceutical products both present and future, (2) to address the needs of a biopharmaceutical manufacturer from the beginning to the end of the clinical development stages and including post market approval, and (3) to be adaptable to the constantly changing CMC regulatory compliance requirements and guidance. Trying to accomplish this task was a humbling experience for this author! In Chapter 1, the CMC regulatory process is explained, the breadth of products included under the umbrella ofbiopharmaceuticals are identified, and the track record for the pharmaceutical and biopharmaceutical industry in meeting CMC regulatory compliance is discussed. In Chapter 2, while there are many CMC commonalities between biopharmaceuticals and chemically-synthesized pharmaceuticals, the significant differences in the way the regulatory agencies handle them are examined and the reasons for why such differences are necessary is discussed. Also, the importance of CMC FDA is stressed.

Reviewing Clinical Trials

Author : Chinese University of Hong Kong
ISBN : 9881904110
Genre : Clinical trials
File Size : 72. 3 MB
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The idea for this manual came from Pfizer in the US, which provided the Clinical Trials Centre at The University of Hong Kong, Hong Kong SAR, PR China with a nonbinding grant for its development. The general project layout protocol was accepted by Pfizer in July 2009. Pfizer has not in any way interfered with the project, except for providing nonbinding comments to the final product. The entire text of this manual was written by Johan PE Karlberg. Marjorie A Speers provided considerable and essential comments on the contents and the first and subsequent drafts. A group of international human research protection experts mostly working in non-profit institutions or organisations - see Contributors for details - reviewed and provided important comments on the contents and final draft. It was solely created with the intention to promote human research protection of participants in clinical trials. This manual will be translated into numerous languages and is provided free of charge as an electronic file over the Internet ( and offered in print for a fee. The objective beyond this project is to establish educational activities, developed around the manual, and jointly organised with leading academic institutions worldwide.

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