Author: California. Resources Agency
Publisher:
ISBN:
Category : Environmental law
Languages : en
Pages :

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Author:
Publisher:
ISBN:
Category : Highway planning
Languages : en
Pages : 44

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Book Description
This guide was written as a quick primer for transportation professionals and analysts who assess the impacts of proposed transportation actions on communities. It outlines the community impact assessment process, highlights critical areas that must be examined, identifies basic tools and information sources, and stimulates the thought-process related to individual projects. In the past, the consequences of transportation investments on communities have often been ignored or introduced near the end of a planning process, reducing them to reactive considerations at best. The goals of this primer are to increase awareness of the effects of transportation actions on the human environment and emphasize that community impacts deserve serious attention in project planning and development-attention comparable to that given the natural environment. Finally, this guide is intended to provide some tips for facilitating public involvement in the decision making process.

Author:
Publisher:
ISBN:
Category : Coastal zone management
Languages : en
Pages : 41

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Author: Ronald E. Bass
Publisher:
ISBN:
Category : Law
Languages : en
Pages : 520

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Author: Ohio. General Assembly. Senate
Publisher:
ISBN:
Category : Legislation
Languages : en
Pages : 114

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Author: United States. Department of the Army
Publisher:
ISBN:
Category : Real property
Languages : en
Pages : 24

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Author: John Geigert
Publisher: Springer
ISBN: 3030137546
Category : Medical
Languages : en
Pages : 446

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Book Description
Biopharmaceuticals (i.e., biological medicines sourced from genetically-engineered living systems) for treatment of human diseases have become a significant percentage of the pharmaceutical industry. And not just the recombinant DNA-derived proteins and monoclonal antibodies (both from the innovators and biosimilars); but now, an increasing awareness of the importance of gene therapy and genetically engineered cellular medicinal products. These biopharmaceuticals are being developed by many companies whose Chemistry, Manufacturing & Control (CMC) teams have varying degrees of familiarity or experience with the CMC strategy and regulatory compliance requirements for these challenging products. Companies clearly plan out the strategy for their clinical study plans, but frequently, the development of a strategy for CMC is an afterthought. Coupled with the complexity of the biopharmaceutical manufacturing processes and products, and this can be a recipe for disaster. The third edition of this book provides insights and practical guidance for the CMC teams to develop an acceptable cost-effective, risk-based CMC regulatory compliance strategy for all biopharmaceuticals (recombinant proteins, monoclonal antibodies, genetically engineered viruses and genetically engineered human cells) from early clinical stage development through market approval. The third edition of this book provides added coverage for the biosimilars, antibody drug conjugates (ADCs), bispecific antibodies, genetically engineered viruses, and genetically engineered cells. This third edition of the book also addresses the heightened pressure on CMC regulatory compliance timelines due to the introduction of expedited clinical pathways moving the clinical development closer to a seamless phase process (e.g., FDA Breakthrough Therapy designation, CBER Regenerative Medicine Advanced Therapy (RMAT) designation, EMA Priority Medicines (PRIME) designation). The Challenge of CMC Regulatory Compliance for Biopharmaceuticals is essential, practical information for all pharmaceutical development scientists, Manufacturing and Quality Unit staff, Regulatory Affairs personnel, and senior management involved in the manufacture of biopharmaceuticals.

Author: Paras N. Prasad
Publisher: John Wiley & Sons
ISBN: 0471465399
Category : Science
Languages : en
Pages : 622

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Book Description
Paras Prasad’s text provides a basic knowledge of a broad range of topics so that individuals in all disciplines can rapidly acquire the minimal necessary background for research and development in biophotonics. Introduction to Biophotonics serves as both a textbook for education and training as well as a reference book that aids research and development of those areas integrating light, photonics, and biological systems. Each chapter contains a topic introduction, a review of key data, and description of future directions for technical innovation. Introduction to Biophotonics covers the basic principles of Optics Optical spectroscopy Microscopy Each section also includes illustrated examples and review questions to test and advance the reader’s knowledge. Sections on biosensors and chemosensors, important tools for combating biological and chemical terrorism, will be of particular interest to professionals in toxicology and other environmental disciplines. Introduction to Biophotonics proves a valuable reference for graduate students and researchers in engineering, chemistry, and the life sciences.

Author:
Publisher:
ISBN:
Category : Hazardous wastes
Languages : en
Pages : 690

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Author: Morton Walker D.P.M.
Publisher: Penguin
ISBN: 1101662344
Category : Health & Fitness
Languages : en
Pages : 354

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Book Description
An easy-to-understand, up-to-date guide on the highly publicized drug, DMSO DMSO—dimethyl sulfoxide—is a simple by-product of wood and has been called a “miracle” drug, capable of relieving pain, diminishing swelling, reducing inflammation, encouraging healing, and restoring normal function. In this groundbreaking work, award-winning health science writer Dr. Morton Walker examines the powerful and compelling case for the use of DMSO in the treatment of many debilitating disease and health-related problems. In DMSO: Nature’s Healer, Dr. Walker cites documented cases of its astounding use in healing and prevention of a host of health disorders, including arthritis, stroke, cancer, mental retardation, and sports and auto injuries. He also recounts the dramatic story of the long struggle to gain FDA approval of DMSO.