Code of Federal Regulations

Code of Federal Regulations
Author:
Publisher:
Total Pages: 1096
Release: 2007
Genre: Administrative law
ISBN:

Special edition of the Federal register. Subject/agency index for rules codified in the Code of Federal Regulations, revised as of Jan. 1 ...

Medical Product Regulatory Affairs

Medical Product Regulatory Affairs
Author: John J. Tobin
Publisher: John Wiley & Sons
Total Pages: 304
Release: 2011-08-24
Genre: Science
ISBN: 3527644717

Written in a clear and concise style by an experienced author, this attractively-priced book covers regulatory affairs in all major global markets for pharmaceuticals and medical devices, making it the most comprehensive in its field. Following a look at drug development, complete sections are devoted to national and EU regulatory issues, manufacturing license application and retention, and regulation in the USA. Other topics dealt with include CDER, CBER and marketing and manufacturing licenses, the ICH process and Good Laboratory/Clinical/Manufacturing Practices. Everything pharmacologists, bioengineers, pharma engineers, students in pharmacy and those working in the pharmaceutical industry need to know about medical regulatory affairs.

Excipient Development for Pharmaceutical, Biotechnology, and Drug Delivery Systems

Excipient Development for Pharmaceutical, Biotechnology, and Drug Delivery Systems
Author: Ashok Katdare
Publisher: CRC Press
Total Pages: 474
Release: 2006-07-28
Genre: Medical
ISBN: 1420004131

To facilitate the development of novel drug delivery systems and biotechnology-oriented drugs, the need for new, yet to be developed, and approved excipients continues to increase. Excipient Development for Pharmaceutical, Biotechnology, and Drug Delivery Systems serves as a comprehensive source to improve understanding of excipients and forge potential new avenues for regulatory approval. This book presents detailed, up-to-date information on various aspects of excipient development, testing, and technological considerations for their use. It addresses specific details such as historical perspective, preclinical testing, safety, and toxicology evaluation, as well as regulatory, quality, and utility aspects. The text also describes best practices for use of various functional excipients and extensive literature references for all topics.

Beyond the HIPAA Privacy Rule

Beyond the HIPAA Privacy Rule
Author: Institute of Medicine
Publisher: National Academies Press
Total Pages: 334
Release: 2009-03-24
Genre: Computers
ISBN: 0309124999

In the realm of health care, privacy protections are needed to preserve patients' dignity and prevent possible harms. Ten years ago, to address these concerns as well as set guidelines for ethical health research, Congress called for a set of federal standards now known as the HIPAA Privacy Rule. In its 2009 report, Beyond the HIPAA Privacy Rule: Enhancing Privacy, Improving Health Through Research, the Institute of Medicine's Committee on Health Research and the Privacy of Health Information concludes that the HIPAA Privacy Rule does not protect privacy as well as it should, and that it impedes important health research.

Handbook of Drug Monitoring Methods

Handbook of Drug Monitoring Methods
Author: Amitava Dasgupta
Publisher: Springer Science & Business Media
Total Pages: 441
Release: 2007-10-23
Genre: Medical
ISBN: 1588297802

Written in a handbook style with specific methods and tips on eliminating false positive and false negative results, this book is a practical guide to the detailed mechanisms of such occurrences.

Design of Biomedical Devices and Systems, Third Edition

Design of Biomedical Devices and Systems, Third Edition
Author: Paul H. King
Publisher: CRC Press
Total Pages: 520
Release: 2014-07-29
Genre: Medical
ISBN: 1466569131

Apply a Wide Variety of Design Processes to a Wide Category of Design Problems Design of Biomedical Devices and Systems, Third Edition continues to provide a real-world approach to the design of biomedical engineering devices and/or systems. Bringing together information on the design and initiation of design projects from several sources, this edition strongly emphasizes and further clarifies the standards of design procedure. Following the best practices for conducting and completing a design project, it outlines the various steps in the design process in a basic, flexible, and logical order. What’s New in the Third Edition: This latest edition contains a new chapter on biological engineering design, a new chapter on the FDA regulations for items other than devices such as drugs, new end-of-chapter problems, new case studies, and a chapter on product development. It adds mathematical modeling tools, and provides new information on FDA regulations and standards, as well as clinical trials and sterilization methods. Familiarizes the reader with medical devices, and their design, regulation, and use Considers safety aspects of the devices Contains an enhanced pedagogy Provides an overview of basic design issues Design of Biomedical Devices and Systems, Third Edition covers the design of biomedical engineering devices and/or systems, and is designed to support bioengineering and biomedical engineering students and novice engineers entering the medical device market.