Download or read book California EIR Monitor written by California. Resources Agency and published by . This book was released on 1982 with total page pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Community Impact Assessment written by and published by . This book was released on 1996 with total page 44 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Download or read book San Francisco Bay Plan written by and published by . This book was released on 1983 with total page 41 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book CEQA Deskbook written by Ronald E. Bass and published by . This book was released on 1999 with total page 520 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Senate Joint Resolutions written by Ohio. General Assembly. Senate and published by . This book was released on 1925 with total page 114 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Utilization of written by United States. Department of the Army and published by . This book was released on 1993 with total page 24 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book The Challenge of CMC Regulatory Compliance for Biopharmaceuticals written by John Geigert and published by Springer. This book was released on 2019-05-08 with total page 446 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Download or read book Introduction to Biophotonics written by Paras N. Prasad and published by John Wiley & Sons. This book was released on 2004-01-16 with total page 622 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Download or read book National Biennial RCRA Hazardous Waste Report based on 1989 Data written by and published by . This book was released on 1993 with total page 690 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Dmso written by Morton Walker D.P.M. and published by Penguin. This book was released on 1993-01-01 with total page 354 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Download or read book Geologic History of Middle California written by Arthur David Howard and published by Univ of California Press. This book was released on 1979-01-01 with total page 142 pages. Available in PDF, EPUB and Kindle. Book excerpt: 00 Only recently has the astonishing modern theory of moving crustal plates enabled us to understand fully how the picturesque landscape of the San Francisco Bay Region and its surrounding areas has come into existence. In this book Howard tells the dramatic story, illustrated by clear, graphic sequential drawings: the continual remaking of the earth's surface on a time scale so immense human minds can scarcely grasp it. Only recently has the astonishing modern theory of moving crustal plates enabled us to understand fully how the picturesque landscape of the San Francisco Bay Region and its surrounding areas has come into existence. In this book Howard tells the dramatic story, illustrated by clear, graphic sequential drawings: the continual remaking of the earth's surface on a time scale so immense human minds can scarcely grasp it.
Download or read book Industrial Pharmaceutical Biotechnology written by Heinrich Klefenz and published by Wiley-VCH. This book was released on 2002-04-22 with total page 328 pages. Available in PDF, EPUB and Kindle. Book excerpt: This volume focuses on pharmaceutical biotechnology as a key area of life sciences. The complete range of concepts, processes and technologies of biotechnology is applied in modern industrial pharmaceutical research, development and production. The results of genome sequencing and studies of biological-genetic function are combined with chemical, micro-electronic and microsystem technology to produce medical devices and diagnostic biochips. A multitude of biologically active molecules is expanded by additional novel structures created with newly arranged gene clusters and bio-catalytic chemical processes. New organisational structures in the co-operation of institutes, companies and networks enable faster knowledge and product development and immediate application of the results of research and process development. This book is the ideal source of information for scientists and engineers in research and development, for decision-makers in biotech, pharma and chemical corporations, as well as for research institutes, but also for founders of biotech companies and people working for venture capital corporations.
Download or read book American River Watershed California written by and published by . This book was released on 1987 with total page 52 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Cosmetic and Pharmaceutical Applications of Polymers written by T. Cheng and published by Springer Science & Business Media. This book was released on 2012-12-06 with total page 409 pages. Available in PDF, EPUB and Kindle. Book excerpt: Polymers continue to show almost amazing versatility. We have always known that polymers could be used for trinkets, toys and dishes. Now, however, we are no longer surprised to encounter these adaptable mate rials in almost every place we look. We find them in our cars, tools, electronic devices, building materials, etc. The use of polymeric mate rials in medicine is also well documented in previous books by one of the Editors (Gebelein) and by others. Likewise, the use of polymeric mate rials in pharmaceutical applications, especially in controlled release systems, is also well established. Nevertheless, the use of these ubiquitous chemicals is far less ob vious in the field of cosmetics, although modern cosmetic preparations rely heavily on polymers and this trend is certain to increase. This book brings together much of the basic information on polymers in cosmetics and compares this usage with similar applications in pharmaceutical and medical applications. Cosmetics, like medicine and pharmacy, dates back to antiquity. We can find uses of perfumes, balms and ointments in various old books, such as the Bible. For example, the use of ointments and balms is noted more than thirty eight times, and perfumes and related materials are cited at least twenty nine times in the Bible.
Download or read book Quality by Design for Biopharmaceutical Drug Product Development written by Feroz Jameel and published by Springer. This book was released on 2015-04-01 with total page 710 pages. Available in PDF, EPUB and Kindle. Book excerpt: This volume explores the application of Quality by Design (QbD) to biopharmaceutical drug product development. Twenty-eight comprehensive chapters cover dosage forms, liquid and lyophilized drug products. The introductory chapters of this book define key elements of QbD and examine how these elements are integrated into drug product development. These chapters also discuss lessons learned from the FDA Office of Biotechnology Products pilot program. Following chapters demonstrate how QbD is used for formulation development ranging from screening of formulations to developability assessment to development of lyophilized and liquid formats. The next few chapters study the use of small-scale and surrogate models as well as QbD application to drug product processes such as drug substance freezing and thawing, mixing, sterile filtration, filling, lyophilization, inspection and shipping and handling. Later chapters describe more specialized applications of QbD in the drug product realm. This includes the use of QbD in primary containers, devices and combination product development. The volume also explores QbD applied to vaccine development, automation, mathematical modeling and monitoring, and controlling processes and defining control strategies. It concludes with a discussion on the application of QbD to drug product technology transfer as well as overall regulatory considerations and lifecycle management. Quality by Design for Biopharmaceutical Drug Product Development is an authoritative resource for scientists and researchers interested in expanding their knowledge on QbD principles and uses in creating better drugs.
Download or read book Hyperbaric Oxygen Therapy Indications written by Linda Ed Weaver and published by . This book was released on 2014-04-01 with total page 415 pages. Available in PDF, EPUB and Kindle. Book excerpt: The Undersea and Hyperbaric Medical Society (UHMS) is an international, non-profit organization serving over 2,400 members from more than 50 countries. The UHMS is the primary source of scientific information for diving and hyperbaric medicine physiology worldwide, the breadth of which is illustrated in the triennial report, Hyperbaric Oxygen Therapy Indications. With leading experts authoring chapters in their respective fields, this publication continues to provide the most current and up to date guidance and support for scientists and practitioners of hyperbaric oxygen therapy. Hyperbaric Oxygen Therapy Indications, currently in its thirteenth edition, has grown in size and depth to reflect the evolution of the literature on the approved use of hyperbarics from both a clinical practice standpoint and insurance coverage perspective. To date, the committee recognizes fourteen indications, including the new indication, idiopathic sudden sensorineural hearing loss. Additionally, this book continues to be used by the Centers for Medicare and Medicaid Services and other third party insurance carriers in determining payment for HBO2 services.
Download or read book California Riparian Systems written by Richard E. Warner and published by Univ of California Press. This book was released on 1984-01-01 with total page 1076 pages. Available in PDF, EPUB and Kindle. Book excerpt: This volume presents 135 of the papers presented at the 1981 California Riparian Systems Conference. The papers address all aspects of riparian systems: habitat, wildlife, land management, land use policy planning, conservation and water resource management.
