The Combination Products Handbook
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| Author | : Susan Neadle |
| Publisher | : CRC Press |
| Total Pages | : 439 |
| Release | : 2023-05-16 |
| Genre | : Medical |
| ISBN | : 1000874583 |
Combination products are therapeutic and diagnostic products that combine drugs, devices, and/or biological products. According to the US Food and Drug Administration (FDA), “a combination product is one composed of any combination of a drug and a device; a biological product and a device; a drug and a biological product; or a drug, device and a biological product.” Examples include prefilled syringes, pen injectors, autoinjectors, inhalers, transdermal delivery systems, drug-eluting stents, and kits containing drug administration devices co-packaged with drugs and/or biological products. This handbook provides the most up-to-date information on the development of combination products, from the technology involved to successful delivery to market. The authors present important and up-to-the-minute pre- and post-market reviews of international combination product regulations, guidance, considerations, and best practices. This handbook: Brings clarity of understanding for global combination products guidance and regulations Reviews the current state-of-the-art considerations and best practices spanning the combination product lifecycle, pre-market through post-market Reviews medical product classification and assignment issues faced by global regulatory authorities and industry The editor is a recognized international Combination Products and Medical Device expert with over 35 years of industry experience and has an outstanding team of contributors. Endorsed by AAMI – Association for the Advancement of Medical Instrumentation.
| Author | : Susan W. Neadle |
| Publisher | : |
| Total Pages | : 0 |
| Release | : 2023 |
| Genre | : |
| ISBN | : 9781032291635 |
"Combination products are therapeutic and diagnostic products that combine drugs, devices, and/or biological products. According to the FDA, "a combination product is one composed of any combination of a drug, a device, and a biological product. Examples include prefilled syringes, pen injectors, auto-injectors, inhalers, transdermal pumps and patches, and kits containing drug administration devices or components. This handbook provides the most up to date information on the development of combination products, from the technology involved to successful delivery. The authors present important and up to the minute pre and post market reviews of combination products as well as regulation"--
| Author | : Smita Gopalaswamy |
| Publisher | : CRC Press |
| Total Pages | : 260 |
| Release | : 2008-04-22 |
| Genre | : Business & Economics |
| ISBN | : 1420064517 |
The field of combination product development (products born of the integration of medical devices, biologics, and drugs) is so new that, while literature abounds on each part individually, there are very few publications, including FDA documents, available concerning the unique challenges posed by this nascent but fast-growing area. Providing
| Author | : Stephen M. Kanovsky |
| Publisher | : |
| Total Pages | : 672 |
| Release | : 2020-09 |
| Genre | : Drugs |
| ISBN | : 9781935065876 |
FDLI's popular reference book, A Practical Guide to FDA's Food and Drug Law and Regulation, Seventh Edition, provides an introduction to the laws and regulations governing development, marketing, and sale of FDA-regulated products, including topics on food, drugs, medical devices, biologics, dietary supplements, cosmetics, new animal drugs, cannabis, and tobacco and nicotine products. Structured to serve as a reference and as a teaching tool, the book offers practical legal and regulatory fundamentals, and each chapter builds sequentially from the last to provide an accessible overview of the key topics relevant to practitioners of food and drug law and regulation. This book is a standard legal text in law schools and graduate regulatory programs and has been cited as a reference in judicial opinions (including the U.S. Supreme Court). This Seventh Edition includes new sections on controlled substances, compounded drugs, and cannabis and cannabis-derived compounds. It also incorporates the latest amendments to the Federal Food, Drug, and Cosmetic Act, as well as FDA regulations and guidances.
| Author | : Susan Onel |
| Publisher | : |
| Total Pages | : 1112 |
| Release | : 2016-11 |
| Genre | : Medical instruments and apparatus |
| ISBN | : 9781402427749 |
This title walks you through the current regulatory requirements and provides in-depth coverage of individual FDA programs that cover everything from conducting clinical trials, preparing successful premarket submissions, adhering to quality system requirements, and fulfilling post-market obligations.
| Author | : Jones & Bartlett Learning, |
| Publisher | : Jones & Bartlett Publishers |
| Total Pages | : 882 |
| Release | : 2009-05-04 |
| Genre | : Medical |
| ISBN | : 1449658180 |
The only reference that covers two or more drugs administered simultaneously! Using one formulation to administer two or more medications simultaneously can simplify a patient's drug regimen and even improve compliance. For the nurse, however, the convenience of combination drugs is linked with the added responsibility to provide safe, effective drug therapy and complete patient teaching about the medications. Nurse's Handbook of Combination Drugs, Second Edition meets your need for accurate, up-to-date, and easy-to-use drug information, preparing you to administer these drugs, teach your patients about them, and provide safe and effective care. Here's what you'll find in the handbook: An organization that groups drugs into body system chapters and alphabetizes the entries for quick finding. In each chapter, you'll find all the combination drugs to treat that system's disorders Concise drug entries that use a consistent format. Use one entry and you'll know how all the others are formatted Comprehensive index listing each generic in the combination and all trade names
| Author | : Jack Wong |
| Publisher | : CRC Press |
| Total Pages | : 806 |
| Release | : 2022-01-27 |
| Genre | : Medical |
| ISBN | : 1000440516 |
This handbook covers medical device regulatory systems in different countries, ISO standards for medical devices, clinical trial and regulatory requirements, and documentation for application. It is the first to cover the medical device regulatory affairs in Asia. Experts from influential international regulatory bodies, including the US Food and Drug Administration (FDA), UK Medicines and Healthcare Products Regulatory Agency, Japan Pharmaceuticals and Medical Devices Agency, Saudi Food and Drug Authority, Korea Testing Laboratory, Taiwan FDA, World Health Organization, Asian Harmonization Working Party, Regulatory Affairs Professionals Society, and British Standards Institution, have contributed to the book. Government bodies, the medical device industry, academics, students, and general readers will find the book immensely useful for understanding the global regulatory environment and in their research and development projects.
| Author | : Kim Huynh-Ba |
| Publisher | : Springer Science & Business Media |
| Total Pages | : 389 |
| Release | : 2008-11-16 |
| Genre | : Medical |
| ISBN | : 0387856277 |
This handbook is the first to cover all aspects of stability testing in pharmaceutical development. Written by a group of international experts, the book presents a scientific understanding of regulations and balances methodologies and best practices.
| Author | : Mark Allen Durivage |
| Publisher | : Quality Press |
| Total Pages | : 386 |
| Release | : 2016-05-26 |
| Genre | : Business & Economics |
| ISBN | : 0873899334 |
The purpose of this handbook is to assist individuals for the Certified Pharmaceutical Good Manufacturing Practices Professional (CPGP) examination and provide a reference for the practitioner. The second edition reflects the Body of Knowledge which was updated in 2015. This edition has also incorporated additional information including updated references. The updates reflect the current trends and expectations of the evolving pharmaceutical industry driven by consumer expectations and regulatory oversight. This handbook covers compliance with good manufacturing practices (GMPs), as regulated and guided by national and international agencies for the pharmaceutical industry. It covers finished human and veterinary drugs and biologics, and combination devices, as well as their component raw materials (including active pharmaceutical ingredients (APIs) and excipients), and packaging and labeling operations.
| Author | : Grant S. Lipman |
| Publisher | : Simon and Schuster |
| Total Pages | : 119 |
| Release | : 2013-08-13 |
| Genre | : Sports & Recreation |
| ISBN | : 1626365377 |
The Wilderness First Aid Handbook is a handy, quick-reference guide easily accessible with basic wilderness first aid knowledge, but it does not require advanced degrees or experience with medicine and prehospital care. Recognizing that certain knowledge and procedures are outside the scope of a layperson’s training, Dr. Grant Lipman limits the use of technical terms and advanced techniques that may be unfamiliar to some readers or beyond their comfort zone. This system-based, easy-to-follow guide assists the first aid provider when encountering most wilderness emergencies, from cold and heat concerns and blister treatments to high altitude illness and lightning injury prevention—and much more. Typically the most challenging decision in the wilderness environment is when to evacuate a sick or potentially sick person, and as such, each section has detailed decision-making steps to inform you of when to be concerned and when to get out. This guidance is based upon the recent evidence-based consensus statement published by the Wilderness Medical Society on the scope of practice of wilderness first aid. Filled with original, full-color artwork illustrating the techniques and procedures described and with internal-spiral binding and waterproof pages handy for travel into extreme environments, The Wilderness First Aid Handbook is a must-have for every back pocket or backpack.
